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Stepping Together for Children After Trauma, Norway (NorStep)

Primary Purpose

PTSD, Sleep Disorder, Depressive Symptoms

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Stepping Together for Children after Trauma (ST-CT)
Usual care
Sponsored by
Norwegian Center for Violence and Traumatic Stress Studies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PTSD focused on measuring Posttraumatic stress symptoms, Parent-led treatment, Cost-effectiveness, Childhood trauma

Eligibility Criteria

7 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Child is between 7-12 years Exposed to a potentially traumatizing event according to the DSM-5 A-criterion Has a minimum of 5 symptoms of post-traumatic stress (1 symptom must be re-experiencing or avoidance) ≥3 years at the time of the traumatic event to ensure an explicit memory of the event ≥1 month since the traumatic event, according to the diagnostic criteria for PTSD The child must confirm in a conversation alone with the therapist that they feel safe at home and together with the parent and that they are not exposed to ongoing trauma. Exclusion Criteria: Suspicions of psychosis, active suicidality, serious intellectual disability, or lack of Norwegian skills to complete the workbook A psychotropic medication regime that has not been stable for at least 4 weeks (2 weeks for stimulants/benzodiazepines) Currently receives other trauma treatment. Caregiver/family exclusion criteria for participation: A caregiver that is the cause of the trauma exposure can neither be the caregiver that leads the treatment nor live in the same household as the child at the time of treatment The caregiver has had a substance use disorder within the past 3 months, suspected suicidality or insufficient Norwegian language skills to complete the workbook/treatment without use of an interpreter.

Sites / Locations

  • Asker kommuneRecruiting
  • NKVTSRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stepping Together for Children after Trauma (ST-CT)

Usual care

Arm Description

Parent-led, therapist assisted CBT treatment

The types of interventions normally provided in the first-line municipal services

Outcomes

Primary Outcome Measures

Child and Adolescent Trauma Screen 2.0 (CATS 2.0)
The CATS 2.0 assesses child PTSD in the last 4 weeks, according to the DSM-5 and ICD-11 manuals. It includes 15 items of trauma exposure; 20 symptoms of PTS and complex-PTS (intrusions/re-experiencing, avoidance, negative changes in cognition/mood, hyperarousal, and disturbances in self-organization), and 5 items assessing the symptoms' interference on psychosocial functioning. Symptom scores range from 0-60 with higher scores indicating higher levels of PTSD symptoms.
Child and Adolescent Trauma Screen 2.0 (CATS 2.0)
The CATS 2.0 assesses child PTSD in the last 4 weeks, according to the DSM-5 and ICD-11 manuals. It includes 15 items of trauma exposure; 20 symptoms of PTS and complex-PTS (intrusions/re-experiencing, avoidance, negative changes in cognition/mood, hyperarousal, and disturbances in self-organization), and 5 items assessing the symptoms' interference on psychosocial functioning. Symptom scores range from 0-60 with higher scores indicating higher levels of PTSD symptoms.
Child and Adolescent Trauma Screen 2.0 (CATS 2.0)
The CATS 2.0 assesses child PTSD in the last 4 weeks, according to the DSM-5 and ICD-11 manuals. It includes 15 items of trauma exposure; 20 symptoms of PTS and complex-PTS (intrusions/re-experiencing, avoidance, negative changes in cognition/mood, hyperarousal, and disturbances in self-organization), and 5 items assessing the symptoms' interference on psychosocial functioning. Symptom scores range from 0-60 with higher scores indicating higher levels of PTSD symptoms.
Child and Adolescent Trauma Screen 2.0 (CATS 2.0)
The CATS 2.0 assesses child PTSD in the last 4 weeks, according to the DSM-5 and ICD-11 manuals. It includes 15 items of trauma exposure; 20 symptoms of PTS and complex-PTS (intrusions/re-experiencing, avoidance, negative changes in cognition/mood, hyperarousal, and disturbances in self-organization), and 5 items assessing the symptoms' interference on psychosocial functioning. Symptom scores range from 0-60 with higher scores indicating higher levels of PTSD symptoms.
Child and Adolescent Trauma Screen 2.0 (CATS 2.0)
The CATS 2.0 assesses child PTSD in the last 4 weeks, according to the DSM-5 and ICD-11 manuals. It includes 15 items of trauma exposure; 20 symptoms of PTS and complex-PTS (intrusions/re-experiencing, avoidance, negative changes in cognition/mood, hyperarousal, and disturbances in self-organization), and 5 items assessing the symptoms' interference on psychosocial functioning. Symptom scores range from 0-60 with higher scores indicating higher levels of PTSD symptoms.

Secondary Outcome Measures

Short Moods and Feeling Questionnaire (SMFQ)
The measure has 13 items assessing symptoms of depression during the last 2 weeks. Scores range from 0-26 with higher scores indicating greater depressive symptoms.
Short Moods and Feeling Questionnaire (SMFQ)
The measure has 13 items assessing symptoms of depression during the last 2 weeks. Scores range from 0-26 with higher scores indicating greater depressive symptoms.
Short Moods and Feeling Questionnaire (SMFQ)
The measure has 13 items assessing symptoms of depression during the last 2 weeks. Scores range from 0-26 with higher scores indicating greater depressive symptoms.
Short Moods and Feeling Questionnaire (SMFQ)
The measure has 13 items assessing symptoms of depression during the last 2 weeks. Scores range from 0-26 with higher scores indicating greater depressive symptoms.
Short Moods and Feeling Questionnaire (SMFQ)
The measure has 13 items assessing symptoms of depression during the last 2 weeks. Scores range from 0-26 with higher scores indicating greater depressive symptoms.
Sleep Disturbance Scale for Children (SDSC)
The scale includes 26 items that covers 6 types of sleep disorders. It is completed by the child's caregiver, and scores range from 26-130, with a higher score indicating more sleep disturbance.
Sleep Disturbance Scale for Children (SDSC)
The scale includes 26 items that covers 6 types of sleep disorders. It is completed by the child's caregiver, and scores range from 26-130, with a higher score indicating more sleep disturbance.
Sleep Disturbance Scale for Children (SDSC)
The scale includes 26 items that covers 6 types of sleep disorders. It is completed by the child's caregiver, and scores range from 26-130, with a higher score indicating more sleep disturbance.
Sleep Disturbance Scale for Children (SDSC)
The scale includes 26 items that covers 6 types of sleep disorders. It is completed by the child's caregiver, and scores range from 26-130, with a higher score indicating more sleep disturbance.
Sleep Disturbance Scale for Children (SDSC)
The scale includes 26 items that covers 6 types of sleep disorders. It is completed by the child's caregiver, and scores range from 26-130, with a higher score indicating more sleep disturbance.
Children's Post-Traumatic Cognitions Inventory Short (CPTCI-S)
The scale includes 10 items covering the two components "Disturbing and permanent change" and "Feeble person in a scary world". Scores range from 10-40, with higher scores indicating greater post-traumatic cognitions.
Children's Post-Traumatic Cognitions Inventory Short (CPTCI-S)
The scale includes 10 items covering the two components "Disturbing and permanent change" and "Feeble person in a scary world". Scores range from 10-40, with higher scores indicating greater post-traumatic cognitions.
Children's Post-Traumatic Cognitions Inventory Short (CPTCI-S)
The scale includes 10 items covering the two components "Disturbing and permanent change" and "Feeble person in a scary world". Scores range from 10-40, with higher scores indicating greater post-traumatic cognitions.
Children's Post-Traumatic Cognitions Inventory Short (CPTCI-S)
The scale includes 10 items covering the two components "Disturbing and permanent change" and "Feeble person in a scary world". Scores range from 10-40, with higher scores indicating greater post-traumatic cognitions.
Children's Post-Traumatic Cognitions Inventory Short (CPTCI-S)
The scale includes 10 items covering the two components "Disturbing and permanent change" and "Feeble person in a scary world". Scores range from 10-40, with higher scores indicating greater post-traumatic cognitions.
The Parent Child Communication Scale, child version (PCCSc)
10 items covering the child's perception of their communication with their parents. Scores range from 0-40, with higher scores indicating better communication with the parent.
The Parent Child Communication Scale, child version (PCCSc)
10 items covering the child's perception of their communication with their parents. Scores range from 0-40, with higher scores indicating better communication with the parent.
The Parent Child Communication Scale, child version (PCCSc)
10 items covering the child's perception of their communication with their parents. Scores range from 0-40, with higher scores indicating better communication with the parent.
The Parent Child Communication Scale, child version (PCCSc)
10 items covering the child's perception of their communication with their parents. Scores range from 0-40, with higher scores indicating better communication with the parent.
The Parent Child Communication Scale, child version (PCCSc)
10 items covering the child's perception of their communication with their parents. Scores range from 0-40, with higher scores indicating better communication with the parent.
Kidscreen 52 - The Parent Relations and Home Life dimension
The scale has 6 items covering the child's perceptions of being loved, understood, and being able to talk to their parents, during the last week. Scores range from 6-30, with higher scores indicating better relationships and home-life.
Kidscreen 52 - The Parent Relations and Home Life dimension
The scale has 6 items covering the child's perceptions of being loved, understood, and being able to talk to their parents, during the last week. Scores range from 6-30, with higher scores indicating better relationships and home-life.
Kidscreen 52 - The Parent Relations and Home Life dimension
The scale has 6 items covering the child's perceptions of being loved, understood, and being able to talk to their parents, during the last week. Scores range from 6-30, with higher scores indicating better relationships and home-life.
Kidscreen 52 - The Parent Relations and Home Life dimension
The scale has 6 items covering the child's perceptions of being loved, understood, and being able to talk to their parents, during the last week. Scores range from 6-30, with higher scores indicating better relationships and home-life.
Kidscreen 52 - The Parent Relations and Home Life dimension
The scale has 6 items covering the child's perceptions of being loved, understood, and being able to talk to their parents, during the last week. Scores range from 6-30, with higher scores indicating better relationships and home-life.
Kidscreen 52 - The Parent Relations and Home Life dimension
The scale has 6 items covering the child's perceptions of being loved, understood, and being able to talk to their parents, during the last week. Scores range from 6-30, with higher scores indicating better relationships and home-life. For the children in the ST-CT arm only, we include these additional measuring points of Parent Relations to be able to explore change-processed during treatment with ST-CT (assessment at the first four sessions with the therapist).
Strengths and Difficulties Questionnaire (SDQ) - Parent and Teacher report
The SDQ includes 25 items covering five areas of clinical interest: hyperactivity/inattention, emotional symptoms, conduct problems, peer relation problems, and prosocial behaviors. The four first areas (20 items) can be summed to give an overall picture of difficulties, with scores ranging from 0-40, or kept as two subscales (internalizing and externalizing) of 10 items each. Higher scores indicate more difficulties. The fifth area, prosocial behavior, is kept as a separate scale from 0-10 where a higher score indicates more prosocial behaviors/strengths.
Strengths and Difficulties Questionnaire (SDQ) - Parent and Teacher report
The SDQ includes 25 items covering five areas of clinical interest: hyperactivity/inattention, emotional symptoms, conduct problems, peer relation problems, and prosocial behaviors. The four first areas (20 items) can be summed to give an overall picture of difficulties, with scores ranging from 0-40, or kept as two subscales (internalizing and externalizing) of 10 items each. Higher scores indicate more difficulties. The fifth area, prosocial behavior, is kept as a separate scale from 0-10 where a higher score indicates more prosocial behaviors/strengths.
Strengths and Difficulties Questionnaire (SDQ) - Parent and Teacher report
The SDQ includes 25 items covering five areas of clinical interest: hyperactivity/inattention, emotional symptoms, conduct problems, peer relation problems, and prosocial behaviors. The four first areas (20 items) can be summed to give an overall picture of difficulties, with scores ranging from 0-40, or kept as two subscales (internalizing and externalizing) of 10 items each. Higher scores indicate more difficulties. The fifth area, prosocial behavior, is kept as a separate scale from 0-10 where a higher score indicates more prosocial behaviors/strengths.
Strengths and Difficulties Questionnaire (SDQ) - Parent and Teacher report
The SDQ includes 25 items covering five areas of clinical interest: hyperactivity/inattention, emotional symptoms, conduct problems, peer relation problems, and prosocial behaviors. The four first areas (20 items) can be summed to give an overall picture of difficulties, with scores ranging from 0-40, or kept as two subscales (internalizing and externalizing) of 10 items each. Higher scores indicate more difficulties. The fifth area, prosocial behavior, is kept as a separate scale from 0-10 where a higher score indicates more prosocial behaviors/strengths.
Strengths and Difficulties Questionnaire (SDQ) - Parent and Teacher report
The SDQ includes 25 items covering five areas of clinical interest: hyperactivity/inattention, emotional symptoms, conduct problems, peer relation problems, and prosocial behaviors. The four first areas (20 items) can be summed to give an overall picture of difficulties, with scores ranging from 0-40, or kept as two subscales (internalizing and externalizing) of 10 items each. Higher scores indicate more difficulties. The fifth area, prosocial behavior, is kept as a separate scale from 0-10 where a higher score indicates more prosocial behaviors/strengths.
Child Health Utility instrument (CHU9D)
The CHU9D is a measure of health-related quality of life (HRQoL). The scale covers 9 dimensions such as feeling worried, tired, annoyed, and not being able to complete school-work, daily activities and chores. Each dimension has 5 response levels, and higher scores indicate lower HRQoL.
Child Health Utility instrument (CHU9D)
The CHU9D is a measure of health-related quality of life (HRQoL). The scale covers 9 dimensions such as feeling worried, tired, annoyed, and not being able to complete school-work, daily activities and chores. Each dimension has 5 response levels, and higher scores indicate lower HRQoL.
Child Health Utility instrument (CHU9D)
The CHU9D is a measure of health-related quality of life (HRQoL). The scale covers 9 dimensions such as feeling worried, tired, annoyed, and not being able to complete school-work, daily activities and chores. Each dimension has 5 response levels, and higher scores indicate lower HRQoL.
Child Health Utility instrument (CHU9D)
The CHU9D is a measure of health-related quality of life (HRQoL). The scale covers 9 dimensions such as feeling worried, tired, annoyed, and not being able to complete school-work, daily activities and chores. Each dimension has 5 response levels, and higher scores indicate lower HRQoL.
Child Health Utility instrument (CHU9D)
The CHU9D is a measure of health-related quality of life (HRQoL). The scale covers 9 dimensions such as feeling worried, tired, annoyed, and not being able to complete school-work, daily activities and chores. Each dimension has 5 response levels, and higher scores indicate lower HRQoL.
Kidscreen 27: Friends and school dimensions
The scales consists of 4 questions regarding the child's relationship to their friends, and 4 items regarding school functioning during the last week. Items are scored on a 5-point scale, ranging from 4-20 for each subscale. Higher scores indicate better functioning.
Kidscreen 27: Friends and School dimension
The scales consists of 4 questions regarding the child's relationship to their friends, and 4 items regarding school functioning during the last week. Items are scored on a 5-point scale, ranging from 4-20 for each subscale. Higher scores indicate better functioning.
Kidscreen 27: Friends and School dimension
The scales consists of 4 questions regarding the child's relationship to their friends, and 4 items regarding school functioning during the last week. Items are scored on a 5-point scale, ranging from 4-20 for each subscale. Higher scores indicate better functioning.
Kidscreen 27: Friends and School dimension
The scales consists of 4 questions regarding the child's relationship to their friends, and 4 items regarding school functioning during the last week. Items are scored on a 5-point scale, ranging from 4-20 for each subscale. Higher scores indicate better functioning.
Kidscreen 27: Friends and School dimension
The scales consists of 4 questions regarding the child's relationship to their friends, and 4 items regarding school functioning during the last week. Items are scored on a 5-point scale, ranging from 4-20 for each subscale. Higher scores indicate better functioning.
Children's somatic symptoms inventory short form (CSSI-8)
The scale consists of 8 items covering pain and somatic symptoms during the last 2 weeks. Scores range from 0-32 with higher scores indicating more somatic symptoms.
Children's somatic symptoms inventory short form (CSSI-8)
The scale consists of 8 items covering pain and somatic symptoms during the last 2 weeks. Scores range from 0-32 with higher scores indicating more somatic symptoms.
Children's somatic symptoms inventory short form (CSSI-8)
The scale consists of 8 items covering pain and somatic symptoms during the last 2 weeks. Scores range from 0-32 with higher scores indicating more somatic symptoms.
Children's somatic symptoms inventory short form (CSSI-8)
The scale consists of 8 items covering pain and somatic symptoms during the last 2 weeks. Scores range from 0-32 with higher scores indicating more somatic symptoms.
Children's somatic symptoms inventory short form (CSSI-8)
The scale consists of 8 items covering pain and somatic symptoms during the last 2 weeks. Scores range from 0-32 with higher scores indicating more somatic symptoms.
Child sleep quality: objective measure and sleep diary
A non-contact sensor (Somnofy radar, Vital Things A/S) will be used to assess the child's sleep quality in 7 days before treatment start. The sensor registers the child's movement, respiration frequency and sleep quality during the night. A sleep diary will be completed for the same 7 days, with parents recording: when their child falls asleep, wakes up, time taken to fall asleep, awake periods during the night and how well they slept; and the child reporting: if they woke up at time, how many times and how well they slept.
Child sleep quality: objective measure and sleep diary
A non-contact sensor (Somnofy radar, Vital Things A/S) will be used to assess the child's sleep quality in 7 days before treatment start. The sensor registers the child's movement, respiration frequency and sleep quality during the night. A sleep diary will be completed for the same 7 days, with parents recording: when their child falls asleep, wakes up, time taken to fall asleep, awake periods during the night and how well they slept; and the child reporting: if they woke up at time, how many times and how well they slept.
The Rage Outburst and Anger Rating Scale (ROARS)
3 items where the parent rates the frequency, intensity and duration of the child's anger outbursts in the last 7 days. Each item is scored on a 4-point scale, and the sum score ranges from 0 to 9, with a higher score indicating more severe anger outbursts.
The Rage Outburst and Anger Rating Scale (ROARS)
3 items where the parent rates the frequency, intensity and duration of the child's anger outbursts in the last 7 days. Each item is scored on a 4-point scale, and the sum score ranges from 0 to 9, with a higher score indicating more severe anger outbursts.
The Rage Outburst and Anger Rating Scale (ROARS)
3 items where the parent rates the frequency, intensity and duration of the child's anger outbursts in the last 7 days. Each item is scored on a 4-point scale, and the sum score ranges from 0 to 9, with a higher score indicating more severe anger outbursts.
The Rage Outburst and Anger Rating Scale (ROARS)
3 items where the parent rates the frequency, intensity and duration of the child's anger outbursts in the last 7 days. Each item is scored on a 4-point scale, and the sum score ranges from 0 to 9, with a higher score indicating more severe anger outbursts.
The Rage Outburst and Anger Rating Scale (ROARS)
3 items where the parent rates the frequency, intensity and duration of the child's anger outbursts in the last 7 days. Each item is scored on a 4-point scale, and the sum score ranges from 0 to 9, with a higher score indicating more severe anger outbursts.
The Child and Adolescent Serive Use Schedule (CA-SUS)
The parents report the total amount of health and social care services the child has received, including type of services and quantity, and the parents' days of absence from work. The type of services, quantity and parents' work-absence will be transformed to reflect costs related to services used, using cost units from the corresponding financial years. At baseline, service use in the last 6 months will be recorded.
The Child and Adolescent Serive Use Schedule (CA-SUS)
The parents report the total amount of health and social care services the child has received, including type of services and quantity, and the parents' days of absence from work. The type of services, quantity and parents' work-absence will be transformed to reflect costs related to services used, using cost units from the corresponding financial years. At T2, service use in the period since T1 will be recorded.
The Child and Adolescent Serive Use Schedule (CA-SUS)
The parents report the total amount of health and social care services the child has received, including type of services and quantity, and the parents' days of absence from work. The type of services, quantity and parents' work-absence will be transformed to reflect costs related to services used, using cost units from the corresponding financial years. At T3, service use in the period since T2 will be recorded.
The Child and Adolescent Serive Use Schedule (CA-SUS)
The parents report the total amount of health and social care services the child has received, including type of services and quantity, and the parents' days of absence from work. The type of services, quantity and parents' work-absence will be transformed to reflect costs related to services used, using cost units from the corresponding financial years. At T4, service use in the period since T3 will be recorded.
The Child and Adolescent Serive Use Schedule (CA-SUS)
The parents report the total amount of health and social care services the child has received, including type of services and quantity, and the parents' days of absence from work. The type of services, quantity and parents' work-absence will be transformed to reflect costs related to services used, using cost units from the corresponding financial years. At T5, service use in the period since T4 will be recorded.
The ICD-11 criteria of the Child and Adolescent Trauma Screen 2.0 (CATS 2.0)
We will use the 9 items that are prerequisites for assessing both an ICD-11 PTSD diagnosis (complex and non-complex) and and DSM-5 diagnosis, in the CATS 2.0 to assess change processes for the children in the ST-CT arm only. This will be assessed up to 15 times in the period between T1 and T2 (at 11 home parent-child meetings and 4 therapist sessions).

Full Information

First Posted
February 6, 2023
Last Updated
June 13, 2023
Sponsor
Norwegian Center for Violence and Traumatic Stress Studies
Collaborators
Ministry of Health and Care Services, Norway, University of Oslo, King's College London
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1. Study Identification

Unique Protocol Identification Number
NCT05734547
Brief Title
Stepping Together for Children After Trauma, Norway
Acronym
NorStep
Official Title
Stepping Together for Children After Trauma: Investigating Effectiveness of a Parent-led, Therapist Assisted Trauma Treatment in Norwegian Municipal Services (The NorStep Study)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 14, 2023 (Actual)
Primary Completion Date
December 1, 2026 (Anticipated)
Study Completion Date
December 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Norwegian Center for Violence and Traumatic Stress Studies
Collaborators
Ministry of Health and Care Services, Norway, University of Oslo, King's College London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The goal of this randomized controlled trial is to learn about how to effectively help children (aged 7-12) who have developed moderate symptoms of posttraumatic stress after exposure to trauma, and prevent development of more severe problems. The main research questions are: Will the parent-led, therapist assisted treatment "Stepping Together for Children after Trauma" (ST-CT) be more effective, compared to usual care, in reducing symptoms of posttraumatic stress, depression and sleep disorders, and in improving daily functioning for children and their parents after trauma? Is ST-CT implemented to the municipal first-line services cost-effective? Will ST-CT prevent use of health care services and prescribed drugs in the long term? The children and their non-offending caregivers will be randomized to receive treatment with ST-CT or usual care, and symptoms and general functioning will be assessed at five time-points.
Detailed Description
Childhood trauma is a major public health challenge and affects a substantial number of children. Trauma impacts psychological and physical development, as well as long term mental and physical health and behaviour. These adverse outcomes can be prevented through appropriate treatment. Unfortunately, there is a substantial gap between the need for treatment and access to evidence-based care. Low-intensive treatments that utilize and strengthen family resources could contribute to bridging this gap and contribute to improving long-term public health and quality of life. The Stepped Care Cognitive Behavioral Therapy for Children after Trauma (SC-CBT-CT; Salloum et al. .2014) is a promising intervention for traumatized children that consists of two steps: 1) Stepping Together for Children after Trauma (Stepping Together CT, ST-CT), which is a parent-led, therapist-assisted treatment that takes advantage of and strengthens parent resources; and 2) Trauma-Focused Cognitive Behavioral Therapy (TF-CBT; Cohen et al. 2017) which is a therapist-led treatment provided when Stepping Together CT does not sufficiently help the child. Results from a recent randomized control trial (RCT) conducted in the United States, show that SC-CBT-CT is as effective as standard therapist-led TF-CBT in reducing post-traumatic symptoms, depression, sleep disturbance and parental distress, while simultaneously reducing treatment-related costs by 50% (Salloum et al. 2022). In Norway, a recent pilot study found that the first step, ST-CT, is well accepted by children, parents, and therapists, and is feasible as a first-line intervention in the municipal services (ClinicalTrials.gov Identifier: NCT04073862). The current study is an RCT with a hybrid effectiveness-implementation design where ST-CT will be implemented to municipal first-line service centers. Participants will be randomized to either the ST-CT or usual care (UC). We will recruit 160 child-parent dyads through 30 participating municipalities from 2023-2025. This will be the first RCT of ST-CT from an independent research group, with the potential for wider implementation which will greatly impact the resources and tools the municipalities have in facing challenges related to childhood trauma. Aims and data collection: 1) Assess the effectiveness of the parent-led intervention in reducing symptoms on post-traumatic stress, depression, somatic pain and quality of life from both children and caregivers compared to UC. In addition, an objective assessment of quality of sleep will be recorded with a sensor that registers the child's sleep patterns; 2) Evaluate the cost-effectiveness and cost-utility of the ST-CT model; 3) Assess the potential preventive effect of the intervention through long-term follow-up data on use of health services from the Norwegian Patient Registry (NPR), the Norwegian Prescribed Drug Registry (NorPD), and Statistics Norway (SSB); and 4) Investigate barriers and facilitator for implementation, develop culturally adapted treatment material, and an implementation guideline. Assessments of the children and parents will be conducted by an independent assessor at five time points: T1 = baseline, T2 = after completion of the workbook (ST-CT)/9 weeks (UC); T3 = after the maintenance phase (ST-CT)/ 15 weeks (UC); T4 = 6 months after baseline; T5 = 12 months after baseline. A secondary aim is to investigate the change-processes within the ST-CT arm, including when during the treatment change in PTSS occurs and how change is related to parenting practices and the child's perceived relationship to their parent. Assessments related to change-processes will take place in the first 6-9 weeks of treatment, between T1 and T2, for participants in the ST-CT arm only. Specifically, we will collect a short post-traumatic stress symptom assessment (at each parent-child meeting at home, and the first four sessions with the therapist, altogether 15 times), and assess parenting practices and the child's perceived relationship to the parent (the first four sessions with the therapist).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD, Sleep Disorder, Depressive Symptoms, Quality of Life
Keywords
Posttraumatic stress symptoms, Parent-led treatment, Cost-effectiveness, Childhood trauma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
The assessments will be conducted by a clinician from the study group that will be blind to treatment condition
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stepping Together for Children after Trauma (ST-CT)
Arm Type
Experimental
Arm Description
Parent-led, therapist assisted CBT treatment
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
The types of interventions normally provided in the first-line municipal services
Intervention Type
Behavioral
Intervention Name(s)
Stepping Together for Children after Trauma (ST-CT)
Other Intervention Name(s)
Part of the treatment previously called Stepped Care Trauma-focused Cognitive Behavioral Therapy
Intervention Description
ST-CT is Step One of Stepped Care CBT for Children after Trauma (previously called Stepped Care Trauma-focused Cognitive Behavioral Therapy; Salloum et al., 2014). It consists of five components: psychoeducation, stabilization, trauma narrative, in-vivo exposures and consolidation. The parent and child have 11 at-home-meetings and complete tasks in a workbook, Stepping Together (from the Preschool PTSD Treatment by Michael Scheeringa et al), over 6-9 weeks. In addition, there are weekly calls and five sessions with the therapist. Children who meet responder-criteria (i.e., no more than four symptoms of PTSS) continue to a 6-week maintenance phase, after which treatment is complete if the child still meets responder criteria. For those who do not meet responder-criteria, or are not able to complete the workbook, the responsibility for the treatment is transferred from the municipal service level to the corresponding child and adolescent mental health service (BUP).
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Intervention Description
Therapists in the control group will provide the treatment they usually provide, and develop a treatment plan in collaboration with the parents. This may consist of individual sessions with the child, parent sessions, group treatment, meetings with the school and other collaborating services, or referral to the second line mental health centres (BUP).
Primary Outcome Measure Information:
Title
Child and Adolescent Trauma Screen 2.0 (CATS 2.0)
Description
The CATS 2.0 assesses child PTSD in the last 4 weeks, according to the DSM-5 and ICD-11 manuals. It includes 15 items of trauma exposure; 20 symptoms of PTS and complex-PTS (intrusions/re-experiencing, avoidance, negative changes in cognition/mood, hyperarousal, and disturbances in self-organization), and 5 items assessing the symptoms' interference on psychosocial functioning. Symptom scores range from 0-60 with higher scores indicating higher levels of PTSD symptoms.
Time Frame
Baseline (T1)
Title
Child and Adolescent Trauma Screen 2.0 (CATS 2.0)
Description
The CATS 2.0 assesses child PTSD in the last 4 weeks, according to the DSM-5 and ICD-11 manuals. It includes 15 items of trauma exposure; 20 symptoms of PTS and complex-PTS (intrusions/re-experiencing, avoidance, negative changes in cognition/mood, hyperarousal, and disturbances in self-organization), and 5 items assessing the symptoms' interference on psychosocial functioning. Symptom scores range from 0-60 with higher scores indicating higher levels of PTSD symptoms.
Time Frame
Mid-treatment/ 9 weeks (T2)
Title
Child and Adolescent Trauma Screen 2.0 (CATS 2.0)
Description
The CATS 2.0 assesses child PTSD in the last 4 weeks, according to the DSM-5 and ICD-11 manuals. It includes 15 items of trauma exposure; 20 symptoms of PTS and complex-PTS (intrusions/re-experiencing, avoidance, negative changes in cognition/mood, hyperarousal, and disturbances in self-organization), and 5 items assessing the symptoms' interference on psychosocial functioning. Symptom scores range from 0-60 with higher scores indicating higher levels of PTSD symptoms.
Time Frame
Post-treatment/ 15 weeks (T3)
Title
Child and Adolescent Trauma Screen 2.0 (CATS 2.0)
Description
The CATS 2.0 assesses child PTSD in the last 4 weeks, according to the DSM-5 and ICD-11 manuals. It includes 15 items of trauma exposure; 20 symptoms of PTS and complex-PTS (intrusions/re-experiencing, avoidance, negative changes in cognition/mood, hyperarousal, and disturbances in self-organization), and 5 items assessing the symptoms' interference on psychosocial functioning. Symptom scores range from 0-60 with higher scores indicating higher levels of PTSD symptoms.
Time Frame
6 months follow-up (T4)
Title
Child and Adolescent Trauma Screen 2.0 (CATS 2.0)
Description
The CATS 2.0 assesses child PTSD in the last 4 weeks, according to the DSM-5 and ICD-11 manuals. It includes 15 items of trauma exposure; 20 symptoms of PTS and complex-PTS (intrusions/re-experiencing, avoidance, negative changes in cognition/mood, hyperarousal, and disturbances in self-organization), and 5 items assessing the symptoms' interference on psychosocial functioning. Symptom scores range from 0-60 with higher scores indicating higher levels of PTSD symptoms.
Time Frame
12 months follow-up (T5)
Secondary Outcome Measure Information:
Title
Short Moods and Feeling Questionnaire (SMFQ)
Description
The measure has 13 items assessing symptoms of depression during the last 2 weeks. Scores range from 0-26 with higher scores indicating greater depressive symptoms.
Time Frame
Baseline (T1)
Title
Short Moods and Feeling Questionnaire (SMFQ)
Description
The measure has 13 items assessing symptoms of depression during the last 2 weeks. Scores range from 0-26 with higher scores indicating greater depressive symptoms.
Time Frame
Mid-treatment/ 9 weeks (T2)
Title
Short Moods and Feeling Questionnaire (SMFQ)
Description
The measure has 13 items assessing symptoms of depression during the last 2 weeks. Scores range from 0-26 with higher scores indicating greater depressive symptoms.
Time Frame
Post-treatment/ 15 weeks (T3)
Title
Short Moods and Feeling Questionnaire (SMFQ)
Description
The measure has 13 items assessing symptoms of depression during the last 2 weeks. Scores range from 0-26 with higher scores indicating greater depressive symptoms.
Time Frame
6 months follow-up (T4)
Title
Short Moods and Feeling Questionnaire (SMFQ)
Description
The measure has 13 items assessing symptoms of depression during the last 2 weeks. Scores range from 0-26 with higher scores indicating greater depressive symptoms.
Time Frame
12 months follow-up (T5)
Title
Sleep Disturbance Scale for Children (SDSC)
Description
The scale includes 26 items that covers 6 types of sleep disorders. It is completed by the child's caregiver, and scores range from 26-130, with a higher score indicating more sleep disturbance.
Time Frame
Baseline (T1)
Title
Sleep Disturbance Scale for Children (SDSC)
Description
The scale includes 26 items that covers 6 types of sleep disorders. It is completed by the child's caregiver, and scores range from 26-130, with a higher score indicating more sleep disturbance.
Time Frame
Mid-treatment/ 9 weeks (T2)
Title
Sleep Disturbance Scale for Children (SDSC)
Description
The scale includes 26 items that covers 6 types of sleep disorders. It is completed by the child's caregiver, and scores range from 26-130, with a higher score indicating more sleep disturbance.
Time Frame
Post-treatment/ 15 weeks (T3)
Title
Sleep Disturbance Scale for Children (SDSC)
Description
The scale includes 26 items that covers 6 types of sleep disorders. It is completed by the child's caregiver, and scores range from 26-130, with a higher score indicating more sleep disturbance.
Time Frame
6 months follow-up (T4)
Title
Sleep Disturbance Scale for Children (SDSC)
Description
The scale includes 26 items that covers 6 types of sleep disorders. It is completed by the child's caregiver, and scores range from 26-130, with a higher score indicating more sleep disturbance.
Time Frame
12 months follow-up (T5)
Title
Children's Post-Traumatic Cognitions Inventory Short (CPTCI-S)
Description
The scale includes 10 items covering the two components "Disturbing and permanent change" and "Feeble person in a scary world". Scores range from 10-40, with higher scores indicating greater post-traumatic cognitions.
Time Frame
Baseline (T1)
Title
Children's Post-Traumatic Cognitions Inventory Short (CPTCI-S)
Description
The scale includes 10 items covering the two components "Disturbing and permanent change" and "Feeble person in a scary world". Scores range from 10-40, with higher scores indicating greater post-traumatic cognitions.
Time Frame
Mid-treatment/ 9 weeks (T2)
Title
Children's Post-Traumatic Cognitions Inventory Short (CPTCI-S)
Description
The scale includes 10 items covering the two components "Disturbing and permanent change" and "Feeble person in a scary world". Scores range from 10-40, with higher scores indicating greater post-traumatic cognitions.
Time Frame
Post-treatment/ 15 weeks (T3)
Title
Children's Post-Traumatic Cognitions Inventory Short (CPTCI-S)
Description
The scale includes 10 items covering the two components "Disturbing and permanent change" and "Feeble person in a scary world". Scores range from 10-40, with higher scores indicating greater post-traumatic cognitions.
Time Frame
6 months follow-up (T4)
Title
Children's Post-Traumatic Cognitions Inventory Short (CPTCI-S)
Description
The scale includes 10 items covering the two components "Disturbing and permanent change" and "Feeble person in a scary world". Scores range from 10-40, with higher scores indicating greater post-traumatic cognitions.
Time Frame
12 months follow-up (T5)
Title
The Parent Child Communication Scale, child version (PCCSc)
Description
10 items covering the child's perception of their communication with their parents. Scores range from 0-40, with higher scores indicating better communication with the parent.
Time Frame
Baseline (T1)
Title
The Parent Child Communication Scale, child version (PCCSc)
Description
10 items covering the child's perception of their communication with their parents. Scores range from 0-40, with higher scores indicating better communication with the parent.
Time Frame
Mid-treatment/ 9 weeks (T2)
Title
The Parent Child Communication Scale, child version (PCCSc)
Description
10 items covering the child's perception of their communication with their parents. Scores range from 0-40, with higher scores indicating better communication with the parent.
Time Frame
Post-treatment/ 15 weeks (T3)
Title
The Parent Child Communication Scale, child version (PCCSc)
Description
10 items covering the child's perception of their communication with their parents. Scores range from 0-40, with higher scores indicating better communication with the parent.
Time Frame
6 months follow-up (T4)
Title
The Parent Child Communication Scale, child version (PCCSc)
Description
10 items covering the child's perception of their communication with their parents. Scores range from 0-40, with higher scores indicating better communication with the parent.
Time Frame
12 months follow-up (T5)
Title
Kidscreen 52 - The Parent Relations and Home Life dimension
Description
The scale has 6 items covering the child's perceptions of being loved, understood, and being able to talk to their parents, during the last week. Scores range from 6-30, with higher scores indicating better relationships and home-life.
Time Frame
Baseline (T1)
Title
Kidscreen 52 - The Parent Relations and Home Life dimension
Description
The scale has 6 items covering the child's perceptions of being loved, understood, and being able to talk to their parents, during the last week. Scores range from 6-30, with higher scores indicating better relationships and home-life.
Time Frame
Mid-treatment/ 9 weeks (T2)
Title
Kidscreen 52 - The Parent Relations and Home Life dimension
Description
The scale has 6 items covering the child's perceptions of being loved, understood, and being able to talk to their parents, during the last week. Scores range from 6-30, with higher scores indicating better relationships and home-life.
Time Frame
Post-treatment/ 15 weeks (T3)
Title
Kidscreen 52 - The Parent Relations and Home Life dimension
Description
The scale has 6 items covering the child's perceptions of being loved, understood, and being able to talk to their parents, during the last week. Scores range from 6-30, with higher scores indicating better relationships and home-life.
Time Frame
6 months follow-up (T4)
Title
Kidscreen 52 - The Parent Relations and Home Life dimension
Description
The scale has 6 items covering the child's perceptions of being loved, understood, and being able to talk to their parents, during the last week. Scores range from 6-30, with higher scores indicating better relationships and home-life.
Time Frame
12 months follow-up (T5)
Title
Kidscreen 52 - The Parent Relations and Home Life dimension
Description
The scale has 6 items covering the child's perceptions of being loved, understood, and being able to talk to their parents, during the last week. Scores range from 6-30, with higher scores indicating better relationships and home-life. For the children in the ST-CT arm only, we include these additional measuring points of Parent Relations to be able to explore change-processed during treatment with ST-CT (assessment at the first four sessions with the therapist).
Time Frame
Every 2 weeks between T1 and T2 (3 times)
Title
Strengths and Difficulties Questionnaire (SDQ) - Parent and Teacher report
Description
The SDQ includes 25 items covering five areas of clinical interest: hyperactivity/inattention, emotional symptoms, conduct problems, peer relation problems, and prosocial behaviors. The four first areas (20 items) can be summed to give an overall picture of difficulties, with scores ranging from 0-40, or kept as two subscales (internalizing and externalizing) of 10 items each. Higher scores indicate more difficulties. The fifth area, prosocial behavior, is kept as a separate scale from 0-10 where a higher score indicates more prosocial behaviors/strengths.
Time Frame
Baseline (T1)
Title
Strengths and Difficulties Questionnaire (SDQ) - Parent and Teacher report
Description
The SDQ includes 25 items covering five areas of clinical interest: hyperactivity/inattention, emotional symptoms, conduct problems, peer relation problems, and prosocial behaviors. The four first areas (20 items) can be summed to give an overall picture of difficulties, with scores ranging from 0-40, or kept as two subscales (internalizing and externalizing) of 10 items each. Higher scores indicate more difficulties. The fifth area, prosocial behavior, is kept as a separate scale from 0-10 where a higher score indicates more prosocial behaviors/strengths.
Time Frame
Mid-treatment/ 9 weeks (T2)
Title
Strengths and Difficulties Questionnaire (SDQ) - Parent and Teacher report
Description
The SDQ includes 25 items covering five areas of clinical interest: hyperactivity/inattention, emotional symptoms, conduct problems, peer relation problems, and prosocial behaviors. The four first areas (20 items) can be summed to give an overall picture of difficulties, with scores ranging from 0-40, or kept as two subscales (internalizing and externalizing) of 10 items each. Higher scores indicate more difficulties. The fifth area, prosocial behavior, is kept as a separate scale from 0-10 where a higher score indicates more prosocial behaviors/strengths.
Time Frame
Post-treatment/ 15 weeks (T3)
Title
Strengths and Difficulties Questionnaire (SDQ) - Parent and Teacher report
Description
The SDQ includes 25 items covering five areas of clinical interest: hyperactivity/inattention, emotional symptoms, conduct problems, peer relation problems, and prosocial behaviors. The four first areas (20 items) can be summed to give an overall picture of difficulties, with scores ranging from 0-40, or kept as two subscales (internalizing and externalizing) of 10 items each. Higher scores indicate more difficulties. The fifth area, prosocial behavior, is kept as a separate scale from 0-10 where a higher score indicates more prosocial behaviors/strengths.
Time Frame
6 months follow-up (T4)
Title
Strengths and Difficulties Questionnaire (SDQ) - Parent and Teacher report
Description
The SDQ includes 25 items covering five areas of clinical interest: hyperactivity/inattention, emotional symptoms, conduct problems, peer relation problems, and prosocial behaviors. The four first areas (20 items) can be summed to give an overall picture of difficulties, with scores ranging from 0-40, or kept as two subscales (internalizing and externalizing) of 10 items each. Higher scores indicate more difficulties. The fifth area, prosocial behavior, is kept as a separate scale from 0-10 where a higher score indicates more prosocial behaviors/strengths.
Time Frame
12 months follow-up (T5)
Title
Child Health Utility instrument (CHU9D)
Description
The CHU9D is a measure of health-related quality of life (HRQoL). The scale covers 9 dimensions such as feeling worried, tired, annoyed, and not being able to complete school-work, daily activities and chores. Each dimension has 5 response levels, and higher scores indicate lower HRQoL.
Time Frame
Baseline (T1)
Title
Child Health Utility instrument (CHU9D)
Description
The CHU9D is a measure of health-related quality of life (HRQoL). The scale covers 9 dimensions such as feeling worried, tired, annoyed, and not being able to complete school-work, daily activities and chores. Each dimension has 5 response levels, and higher scores indicate lower HRQoL.
Time Frame
Mid-treatment/ 9 weeks (T2)
Title
Child Health Utility instrument (CHU9D)
Description
The CHU9D is a measure of health-related quality of life (HRQoL). The scale covers 9 dimensions such as feeling worried, tired, annoyed, and not being able to complete school-work, daily activities and chores. Each dimension has 5 response levels, and higher scores indicate lower HRQoL.
Time Frame
Post-treatment/ 15 weeks (T3)
Title
Child Health Utility instrument (CHU9D)
Description
The CHU9D is a measure of health-related quality of life (HRQoL). The scale covers 9 dimensions such as feeling worried, tired, annoyed, and not being able to complete school-work, daily activities and chores. Each dimension has 5 response levels, and higher scores indicate lower HRQoL.
Time Frame
6 months follow-up (T4)
Title
Child Health Utility instrument (CHU9D)
Description
The CHU9D is a measure of health-related quality of life (HRQoL). The scale covers 9 dimensions such as feeling worried, tired, annoyed, and not being able to complete school-work, daily activities and chores. Each dimension has 5 response levels, and higher scores indicate lower HRQoL.
Time Frame
12 months follow-up (T5)
Title
Kidscreen 27: Friends and school dimensions
Description
The scales consists of 4 questions regarding the child's relationship to their friends, and 4 items regarding school functioning during the last week. Items are scored on a 5-point scale, ranging from 4-20 for each subscale. Higher scores indicate better functioning.
Time Frame
Baseline (T1)
Title
Kidscreen 27: Friends and School dimension
Description
The scales consists of 4 questions regarding the child's relationship to their friends, and 4 items regarding school functioning during the last week. Items are scored on a 5-point scale, ranging from 4-20 for each subscale. Higher scores indicate better functioning.
Time Frame
Mid-treatment/9 weeks (T2)
Title
Kidscreen 27: Friends and School dimension
Description
The scales consists of 4 questions regarding the child's relationship to their friends, and 4 items regarding school functioning during the last week. Items are scored on a 5-point scale, ranging from 4-20 for each subscale. Higher scores indicate better functioning.
Time Frame
Post-treatment/15 weeks (T3)
Title
Kidscreen 27: Friends and School dimension
Description
The scales consists of 4 questions regarding the child's relationship to their friends, and 4 items regarding school functioning during the last week. Items are scored on a 5-point scale, ranging from 4-20 for each subscale. Higher scores indicate better functioning.
Time Frame
6 months follow-up (T4)
Title
Kidscreen 27: Friends and School dimension
Description
The scales consists of 4 questions regarding the child's relationship to their friends, and 4 items regarding school functioning during the last week. Items are scored on a 5-point scale, ranging from 4-20 for each subscale. Higher scores indicate better functioning.
Time Frame
12 months follow-up (T5)
Title
Children's somatic symptoms inventory short form (CSSI-8)
Description
The scale consists of 8 items covering pain and somatic symptoms during the last 2 weeks. Scores range from 0-32 with higher scores indicating more somatic symptoms.
Time Frame
Baseline (T1)
Title
Children's somatic symptoms inventory short form (CSSI-8)
Description
The scale consists of 8 items covering pain and somatic symptoms during the last 2 weeks. Scores range from 0-32 with higher scores indicating more somatic symptoms.
Time Frame
Mid-treatment/ 9 weeks (T2)
Title
Children's somatic symptoms inventory short form (CSSI-8)
Description
The scale consists of 8 items covering pain and somatic symptoms during the last 2 weeks. Scores range from 0-32 with higher scores indicating more somatic symptoms.
Time Frame
Post-treatment/ 15 weeks (T3)
Title
Children's somatic symptoms inventory short form (CSSI-8)
Description
The scale consists of 8 items covering pain and somatic symptoms during the last 2 weeks. Scores range from 0-32 with higher scores indicating more somatic symptoms.
Time Frame
6 months follow-up (T4)
Title
Children's somatic symptoms inventory short form (CSSI-8)
Description
The scale consists of 8 items covering pain and somatic symptoms during the last 2 weeks. Scores range from 0-32 with higher scores indicating more somatic symptoms.
Time Frame
12 months follow-up (T5)
Title
Child sleep quality: objective measure and sleep diary
Description
A non-contact sensor (Somnofy radar, Vital Things A/S) will be used to assess the child's sleep quality in 7 days before treatment start. The sensor registers the child's movement, respiration frequency and sleep quality during the night. A sleep diary will be completed for the same 7 days, with parents recording: when their child falls asleep, wakes up, time taken to fall asleep, awake periods during the night and how well they slept; and the child reporting: if they woke up at time, how many times and how well they slept.
Time Frame
7 days before treatment starts
Title
Child sleep quality: objective measure and sleep diary
Description
A non-contact sensor (Somnofy radar, Vital Things A/S) will be used to assess the child's sleep quality in 7 days before treatment start. The sensor registers the child's movement, respiration frequency and sleep quality during the night. A sleep diary will be completed for the same 7 days, with parents recording: when their child falls asleep, wakes up, time taken to fall asleep, awake periods during the night and how well they slept; and the child reporting: if they woke up at time, how many times and how well they slept.
Time Frame
7 days post-treatment/ after 15 weeks
Title
The Rage Outburst and Anger Rating Scale (ROARS)
Description
3 items where the parent rates the frequency, intensity and duration of the child's anger outbursts in the last 7 days. Each item is scored on a 4-point scale, and the sum score ranges from 0 to 9, with a higher score indicating more severe anger outbursts.
Time Frame
Baseline (T1)
Title
The Rage Outburst and Anger Rating Scale (ROARS)
Description
3 items where the parent rates the frequency, intensity and duration of the child's anger outbursts in the last 7 days. Each item is scored on a 4-point scale, and the sum score ranges from 0 to 9, with a higher score indicating more severe anger outbursts.
Time Frame
Mid-treatment/9 weeks (T2)
Title
The Rage Outburst and Anger Rating Scale (ROARS)
Description
3 items where the parent rates the frequency, intensity and duration of the child's anger outbursts in the last 7 days. Each item is scored on a 4-point scale, and the sum score ranges from 0 to 9, with a higher score indicating more severe anger outbursts.
Time Frame
Post-treatment/15 weeks (T3)
Title
The Rage Outburst and Anger Rating Scale (ROARS)
Description
3 items where the parent rates the frequency, intensity and duration of the child's anger outbursts in the last 7 days. Each item is scored on a 4-point scale, and the sum score ranges from 0 to 9, with a higher score indicating more severe anger outbursts.
Time Frame
6 months follow-up (T4)
Title
The Rage Outburst and Anger Rating Scale (ROARS)
Description
3 items where the parent rates the frequency, intensity and duration of the child's anger outbursts in the last 7 days. Each item is scored on a 4-point scale, and the sum score ranges from 0 to 9, with a higher score indicating more severe anger outbursts.
Time Frame
12 months follow-up (T5)
Title
The Child and Adolescent Serive Use Schedule (CA-SUS)
Description
The parents report the total amount of health and social care services the child has received, including type of services and quantity, and the parents' days of absence from work. The type of services, quantity and parents' work-absence will be transformed to reflect costs related to services used, using cost units from the corresponding financial years. At baseline, service use in the last 6 months will be recorded.
Time Frame
Baseline (T1)
Title
The Child and Adolescent Serive Use Schedule (CA-SUS)
Description
The parents report the total amount of health and social care services the child has received, including type of services and quantity, and the parents' days of absence from work. The type of services, quantity and parents' work-absence will be transformed to reflect costs related to services used, using cost units from the corresponding financial years. At T2, service use in the period since T1 will be recorded.
Time Frame
Mid-treatment/9 weeks (T2)
Title
The Child and Adolescent Serive Use Schedule (CA-SUS)
Description
The parents report the total amount of health and social care services the child has received, including type of services and quantity, and the parents' days of absence from work. The type of services, quantity and parents' work-absence will be transformed to reflect costs related to services used, using cost units from the corresponding financial years. At T3, service use in the period since T2 will be recorded.
Time Frame
Post-treatment/15 weeks (T3)
Title
The Child and Adolescent Serive Use Schedule (CA-SUS)
Description
The parents report the total amount of health and social care services the child has received, including type of services and quantity, and the parents' days of absence from work. The type of services, quantity and parents' work-absence will be transformed to reflect costs related to services used, using cost units from the corresponding financial years. At T4, service use in the period since T3 will be recorded.
Time Frame
6 months follow-up (T4)
Title
The Child and Adolescent Serive Use Schedule (CA-SUS)
Description
The parents report the total amount of health and social care services the child has received, including type of services and quantity, and the parents' days of absence from work. The type of services, quantity and parents' work-absence will be transformed to reflect costs related to services used, using cost units from the corresponding financial years. At T5, service use in the period since T4 will be recorded.
Time Frame
12 months follow-up (T5)
Title
The ICD-11 criteria of the Child and Adolescent Trauma Screen 2.0 (CATS 2.0)
Description
We will use the 9 items that are prerequisites for assessing both an ICD-11 PTSD diagnosis (complex and non-complex) and and DSM-5 diagnosis, in the CATS 2.0 to assess change processes for the children in the ST-CT arm only. This will be assessed up to 15 times in the period between T1 and T2 (at 11 home parent-child meetings and 4 therapist sessions).
Time Frame
Twice a week between T1 and T2 (at the at-home meetings, 15 assessments)
Other Pre-specified Outcome Measures:
Title
Stressful Life-Events Screening Questionnaire (SLESQ)
Description
SLESQ assesses the parent's life-time exposure to 15 potentially traumatizing events, with scores ranging from 0-15.
Time Frame
Baseline (T1)
Title
Stressful Life-Events Screening Questionnaire (SLESQ)
Description
SLESQ assesses the parent's exposure to 15 potentially traumatizing events since the last assessment. Scores range from 0-15.
Time Frame
Mid-treatment/ 9 weeks (T2)
Title
Stressful Life-Events Screening Questionnaire (SLESQ)
Description
SLESQ assesses the parent's exposure to 15 potentially traumatizing events since the last assessment. Scores range from 0-15.
Time Frame
Post-treatment/ 15 weeks (T3)
Title
Stressful Life-Events Screening Questionnaire (SLESQ)
Description
SLESQ assesses the parent's exposure to 15 potentially traumatizing events since the last assessment. Scores range from 0-15.
Time Frame
6 months follow-up (T4)
Title
Stressful Life-Events Screening Questionnaire (SLESQ)
Description
SLESQ assesses the parent's exposure to 15 potentially traumatizing events since the last assessment. Scores range from 0-15.
Time Frame
12 months follow-up (T5)
Title
International Trauma Questionnaire (ITQ)
Description
The ITQ assesses symptoms of post-traumatic stress disorder (PTSD) and Complex PTSD according to the ICD-11. It includes 18 items, and scores range from 0-90, with higher scores indicating greater PTSD
Time Frame
Baseline (T1)
Title
International Trauma Questionnaire (ITQ)
Description
The ITQ assesses symptoms of post-traumatic stress disorder (PTSD) and Complex PTSD according to the ICD-11. It includes 18 items, and scores range from 0-90, with higher scores indicating greater PTSD
Time Frame
Mid-treatment/ 9 weeks (T2)
Title
International Trauma Questionnaire (ITQ)
Description
The ITQ assesses symptoms of post-traumatic stress disorder (PTSD) and Complex PTSD according to the ICD-11. It includes 18 items, and scores range from 0-90, with higher scores indicating greater PTSD
Time Frame
Post-treatment/ 15 weeks (T3)
Title
International Trauma Questionnaire (ITQ)
Description
The ITQ assesses symptoms of post-traumatic stress disorder (PTSD) and Complex PTSD according to the ICD-11. It includes 18 items, and scores range from 0-90, with higher scores indicating greater PTSD
Time Frame
6 months follow-up (T4)
Title
International Trauma Questionnaire (ITQ)
Description
The ITQ assesses symptoms of post-traumatic stress disorder (PTSD) and Complex PTSD according to the ICD-11. It includes 18 items, and scores range from 0-90, with higher scores indicating greater PTSD
Time Frame
12 months follow-up (T5)
Title
Hopkins Symptom Check List 25 (HSCL-25)
Description
The HSCL-25 measures the parent's symptoms of anxiety and depression during the last 2 weeks. Scores range from 25-100, with higher scores indicating greater anxiety and depression.
Time Frame
Baseline (T1)
Title
Hopkins Symptom Check List 25 (HSCL-25)
Description
The HSCL-25 measures the parent's symptoms of anxiety and depression during the last 2 weeks. Scores range from 25-100, with higher scores indicating greater anxiety and depression.
Time Frame
Mid-treatment/ 9 weeks (T2)
Title
Hopkins Symptom Check List 25 (HSCL-25)
Description
The HSCL-25 measures the parent's symptoms of anxiety and depression during the last 2 weeks. Scores range from 25-100, with higher scores indicating greater anxiety and depression.
Time Frame
Post-treatment/ 15 weeks (T3)
Title
Hopkins Symptom Check List 25 (HSCL-25)
Description
The HSCL-25 measures the parent's symptoms of anxiety and depression during the last 2 weeks. Scores range from 25-100, with higher scores indicating greater anxiety and depression.
Time Frame
6 months follow-up (T4)
Title
Hopkins Symptom Check List 25 (HSCL-25)
Description
The HSCL-25 measures the parent's symptoms of anxiety and depression during the last 2 weeks. Scores range from 25-100, with higher scores indicating greater anxiety and depression.
Time Frame
12 months follow-up (T5)
Title
Parents Emotional Reactions Questionnaire (PERQ)
Description
The scale consists of 15 items covering the parent's emotional reactions (distress, shame and guilt) to their child's trauma during the last 2 weeks. In this study, item 15 (have you felt guilty about not discovering your child's trauma sooner) will not be included, as it is not relevant for many participants. Scores will range from 14-70 with higher scores indicating greater emotional reactions.
Time Frame
Baseline (T1)
Title
Parents Emotional Reactions Questionnaire (PERQ)
Description
The scale consists of 15 items covering the parent's emotional reactions (distress, shame and guilt) to their child's trauma during the last 2 weeks. In this study, item 15 (have you felt guilty about not discovering your child's trauma sooner) will not be included, as it is not relevant for many participants. Scores will range from 14-70 with higher scores indicating greater emotional reactions.
Time Frame
Mid-treatment/ 9 weeks (T2)
Title
Parents Emotional Reactions Questionnaire (PERQ)
Description
The scale consists of 15 items covering the parent's emotional reactions (distress, shame and guilt) to their child's trauma during the last 2 weeks. In this study, item 15 (have you felt guilty about not discovering your child's trauma sooner) will not be included, as it is not relevant for many participants. Scores will range from 14-70 with higher scores indicating greater emotional reactions.
Time Frame
Post-treatment/ 15 weeks (T3)
Title
Parents Emotional Reactions Questionnaire (PERQ)
Description
The scale consists of 15 items covering the parent's emotional reactions (distress, shame and guilt) to their child's trauma during the last 2 weeks. In this study, item 15 (have you felt guilty about not discovering your child's trauma sooner) will not be included, as it is not relevant for many participants. Scores will range from 14-70 with higher scores indicating greater emotional reactions.
Time Frame
6 months follow-up (T4)
Title
Parents Emotional Reactions Questionnaire (PERQ)
Description
The scale consists of 15 items covering the parent's emotional reactions (distress, shame and guilt) to their child's trauma during the last 2 weeks. In this study, item 15 (have you felt guilty about not discovering your child's trauma sooner) will not be included, as it is not relevant for many participants. Scores will range from 14-70 with higher scores indicating greater emotional reactions.
Time Frame
12 months follow-up (T5)
Title
Parent Trauma Response Questionnaire (PTRQ), Child coping dimension
Description
The scale consists of 20 items covering five different types of parent strategies: behavioral avoidance, cognitive avoidance, overprotection, maintaining pre-trauma routines, and approach coping. Scores range from 0-80, with higher scores indicating more of the parent strategy.
Time Frame
Baseline (T1)
Title
Parent Trauma Response Questionnaire (PTRQ), Child coping dimension
Description
The scale consists of 20 items covering five different types of parent strategies: behavioral avoidance, cognitive avoidance, overprotection, maintaining pre-trauma routines, and approach coping. Scores range from 0-80, with higher scores indicating more of the parent strategy.
Time Frame
Mid-treatment/ 9 weeks (T2)
Title
Parent Trauma Response Questionnaire (PTRQ), Child coping dimension
Description
The scale consists of 20 items covering five different types of parent strategies: behavioral avoidance, cognitive avoidance, overprotection, maintaining pre-trauma routines, and approach coping. Scores range from 0-80, with higher scores indicating more of the parent strategy.
Time Frame
Post-treatment/ 15 weeks (T3)
Title
Parent Trauma Response Questionnaire (PTRQ), Child coping dimension
Description
The scale consists of 20 items covering five different types of parent strategies: behavioral avoidance, cognitive avoidance, overprotection, maintaining pre-trauma routines, and approach coping. Scores range from 0-80, with higher scores indicating more of the parent strategy.
Time Frame
6 months follow-up (T4)
Title
Parent Trauma Response Questionnaire (PTRQ), Child coping dimension
Description
The scale consists of 20 items covering five different types of parent strategies: behavioral avoidance, cognitive avoidance, overprotection, maintaining pre-trauma routines, and approach coping. Scores range from 0-80, with higher scores indicating more of the parent strategy.
Time Frame
12 months follow-up (T5)
Title
Implementation Leadership Scale (ILS)
Description
The scale consists of 12 items covering proactive, knowledgeable, supportive and perseverant leadership, and will be completed by the participating therapists. Scores range from 0-48, with higher scores indicating greater implementation leadership.
Time Frame
Before training
Title
Implementation Leadership Scale (ILS)
Description
The scale consists of 12 items covering proactive, knowledgeable, supportive and perseverant leadership, and will be completed by the participating therapists. Scores range from 0-48, with higher scores indicating greater implementation leadership.
Time Frame
4 months after training
Title
Implementation Leadership Scale (ILS)
Description
The scale consists of 12 items covering proactive, knowledgeable, supportive and perseverant leadership, and will be completed by the participating therapists. Scores range from 0-48, with higher scores indicating greater implementation leadership.
Time Frame
8 months after training
Title
Implementation Leadership Scale (ILS)
Description
The scale consists of 12 items covering proactive, knowledgeable, supportive and perseverant leadership, and will be completed by the participating therapists. Scores range from 0-48, with higher scores indicating greater implementation leadership.
Time Frame
12 months after training
Title
Professional Quality of Life Scale (ProQOL-V)
Description
The ProQOL consists of 30 items assessing compassion satisfaction, burnout and secondary traumatic stress in therapists. Scores range from 30-150, with higher scores indicating higher satisfaction/ burnout/ secondary traumatic stress.
Time Frame
Before training
Title
Professional Quality of Life Scale (ProQOL-V)
Description
The ProQOL consists of 30 items assessing compassion satisfaction, burnout and secondary traumatic stress in therapists. Scores range from 30-150, with higher scores indicating higher satisfaction/ burnout/ secondary traumatic stress.
Time Frame
4 months after training
Title
Professional Quality of Life Scale (ProQOL-V)
Description
The ProQOL consists of 30 items assessing compassion satisfaction, burnout and secondary traumatic stress in therapists. Scores range from 30-150, with higher scores indicating higher satisfaction/ burnout/ secondary traumatic stress.
Time Frame
8 months after training
Title
Professional Quality of Life Scale (ProQOL-V)
Description
The ProQOL consists of 30 items assessing compassion satisfaction, burnout and secondary traumatic stress in therapists. Scores range from 30-150, with higher scores indicating higher satisfaction/ burnout/ secondary traumatic stress.
Time Frame
12 months after training
Title
Turnover Intention Scale (TIS)
Description
The TIS includes 6 items measuring therapist's turnover intention. Scores range from 6-30 with higher scores indicating greater turnover intentions.
Time Frame
Before training
Title
Turnover Intention Scale (TIS)
Description
The TIS includes 6 items measuring therapist's turnover intention. Scores range from 6-30 with higher scores indicating greater turnover intentions.
Time Frame
4 months after training
Title
Turnover Intention Scale (TIS)
Description
The TIS includes 6 items measuring therapist's turnover intention. Scores range from 6-30 with higher scores indicating greater turnover intentions.
Time Frame
8 months after training
Title
Turnover Intention Scale (TIS)
Description
The TIS includes 6 items measuring therapist's turnover intention. Scores range from 6-30 with higher scores indicating greater turnover intentions.
Time Frame
12 months after training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Child is between 7-12 years Exposed to a potentially traumatizing event according to the DSM-5 A-criterion Has a minimum of 5 symptoms of post-traumatic stress (1 symptom must be re-experiencing or avoidance) ≥3 years at the time of the traumatic event to ensure an explicit memory of the event ≥1 month since the traumatic event, according to the diagnostic criteria for PTSD The child must confirm in a conversation alone with the therapist that they feel safe at home and together with the parent and that they are not exposed to ongoing trauma. Exclusion Criteria: Suspicions of psychosis, active suicidality, serious intellectual disability, or lack of Norwegian skills to complete the workbook A psychotropic medication regime that has not been stable for at least 4 weeks (2 weeks for stimulants/benzodiazepines) Currently receives other trauma treatment. Caregiver/family exclusion criteria for participation: A caregiver that is the cause of the trauma exposure can neither be the caregiver that leads the treatment nor live in the same household as the child at the time of treatment The caregiver has had a substance use disorder within the past 3 months, suspected suicidality or insufficient Norwegian language skills to complete the workbook/treatment without use of an interpreter.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Silje M Ormhaug, PhD
Phone
+4799609336
Email
s.m.ormhaug@nkvts.no
First Name & Middle Initial & Last Name or Official Title & Degree
Ingeborg Skjærvø, PhD
Email
ingeborg.skjarvo@nkvts.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silje M Ormhaug
Organizational Affiliation
Norwegian Center for Violence and Traumatic Stress Studies (NKVTS)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asker kommune
City
Asker
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Trude Hansen
Facility Name
NKVTS
City
Oslo
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristin Eliassen, MA
Email
krel@nkvts.no
First Name & Middle Initial & Last Name & Degree
Silje Ormhaug, PhD
Email
trinnvissammen@nkvts.no

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-coded individual participant data will be made available after data inclusion upon participants' written consent.
IPD Sharing Time Frame
2026-2032
IPD Sharing Access Criteria
Receiving party must follow the general data protection pegulation (GDPR).
Citations:
PubMed Identifier
35032578
Citation
Salloum A, Lu Y, Chen H, Quast T, Cohen JA, Scheeringa MS, Salomon K, Storch EA. Stepped Care Versus Standard Care for Children After Trauma: A Randomized Non-Inferiority Clinical Trial. J Am Acad Child Adolesc Psychiatry. 2022 Aug;61(8):1010-1022.e4. doi: 10.1016/j.jaac.2021.12.013. Epub 2022 Jan 12.
Results Reference
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PubMed Identifier
25411544
Citation
Salloum A, Scheeringa MS, Cohen JA, Storch EA. Development of Stepped Care Trauma-Focused Cognitive-Behavioral Therapy for Young Children. Cogn Behav Pract. 2014 Feb 1;21(1):97-108. doi: 10.1016/j.cbpra.2013.07.004.
Results Reference
background
Citation
Cohen JA, Mannarino AP, Deblinger E. Treating Trauma and Traumatic Grief in Children and Adolescents. 2nd ed. New York: Guilford Press; 2017
Results Reference
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Stepping Together for Children After Trauma, Norway

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