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Preventing Suicide With Safe Alternatives for Teens and Youths (SAFETY) (SAFETYF2022)

Primary Purpose

Suicide and Self-harm

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Safe Alternatives for Teens and Youths (SAFETY)
Supportive Therapy
Sponsored by
Region Stockholm
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide and Self-harm

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Suicidal behavior (defined as suicide attempt, interrupted suicide attempt, aborted suicide attempt, or preparatory behavior) in the last 3 months
  • Age 10-17 years
  • At least one primary caregiver willing to participate in treatment

Exclusion Criteria:

  • Symptoms requiring other immediate treatment (e.g. psychosis, severe anorexia nervosa)
  • Ongoing treatment with DBT
  • Individual or life circumstances that could complicate or make treatment participation impossible, or that require immediate intervention (e.g., violence in close relationships; intellectual disability)
  • Insufficient understanding of the Swedish language

Sites / Locations

  • Stockholm Regional CouncilRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Safe Alternatives for Teens and Youths (SAFETY)

Supportive Therapy

Arm Description

SAFETY is a transdiagnostic cognitive-behavioral family treatment informed by Dialectical Behavior Therapy (DBT) and Multisystemic Therapy (MST). The twelve week long treatment is principle based, structured in phases, and individually tailored based on a cognitive-behavioral fit analysis that specifies key risk and protective processes. Each session contains one individual component for youth and parents respectively, and one family component where youth and parents work together with therapists to practice skills identified as critical for preventing future suicidal behavior. Treatment targets are arranged in a SAFETY Pyramid, consisting of (a) safe settings; (b) safe people; (c) safe activities and actions; (d) safe thought; and (e) safe stress reactions, emphasizing strengthening protective support and validation within the family and/or social environment surrounding the youth.

Supportive Therapy is a manualized client-centered therapy. The Supportive Therapy will be adapted to match SAFETY to control for nonspecific treatment factors such as therapist characteristics, time, and treatment exposure. The Supportive Therapy program consists of twelve weekly individual sessions with the youth, focusing on the therapeutic supporting relationship between the therapist and the youth, and follow-ups with parents. Therapeutic strategies include acceptance and validation, to increase feelings of connectedness and belonging and counteract thwarted belongingness, helplessness, and hopelessness. Cognitive-behavioral techniques (e.g., active modeling, problem-solving training, cognitive restructuring) are not allowed.

Outcomes

Primary Outcome Measures

Number of completed assessments at week 12
Defined as number of completed assessments at end of intervention (week 12)
Number of completed assessments at 3 months follow-up
Defined as number of completed assessments 3 months after end of intervention
Number of completed assessments at 12 months follow-up
Defined as number of completed assessments 12 months after end of intervention
The fraction of eligible participants who consent to inclusion and randomization
The fraction of potential participants will be determined as the number of eligible persons compared to the number of randomized persons.
Compliance
Compliance will be defined as number of completed sessions.
Credibility/Expectancy Scale (CEQ)
The CEQ is a 6-item measure of treatment credibility and expectancy. Scale points ranges from 0-9 and 0-100%, where a higher score indicates a better outcome.
Client Satisfaction Questionnaire (CSQ)
The CSQ-8 is an 8-item self-rated 4-point scale, measuring different aspects of satisfaction with treatment, e.g. perception of quality of treatment, if the treatment adequately addressed their needs and overall satisfaction. Total range is 8 to 32, with higher values indicating higher satisfaction. Mean in total satisfaction scores on the CSQ-8 for each treatment group at end of treatment will be reported.
Adverse events
Participants are asked to report and rate the discomfort of the eventual adverse events caused by their participation in the treatment.
Columbia Suicide Severity Rating Scale (C-SSRS) as exploratory clinical outcome
The C-SSRS is a 22-item measure assessing the frequency and severity of suicidal ideation, suicidal behaviors, and self-harm. The C-SSRS will be administered as a clinical interview at baseline (week 0).
Columbia Suicide Severity Rating Scale (C-SSRS) as exploratory clinical outcome
See description above (outcome 9). The C-SSRS will be administered as a self-rated measure for weekly assessments during treatment.
Columbia Suicide Severity Rating Scale (C-SSRS) as exploratory clinical outcome
See description above (outcome 9), The C-SSRS will be administered as a clinical interview.
Columbia Suicide Severity Rating Scale (C-SSRS) as exploratory clinical outcome
See description above (outcome 9), The C-SSRS will be administered as a clinical interview.
Columbia Suicide Severity Rating Scale (C-SSRS) as exploratory clinical outcome
See description above (outcome 9), The C-SSRS will be administered as a clinical interview.

Secondary Outcome Measures

Difficulties In Emotion Regulation Scale (DERS)
The DERS is a measure of difficulties in emotion regulation, with 36 items rated on a 1-5 Likert scale, with a higher score indicating greater difficulties with emotion regulation.
Brief 16-item Version of the Difficulties In Emotion Regulation Scale (DERS-16)
DERS-16 is a brief 16-item version of the DERS, see description above, with 16 items rated on a 1-5 Likert scale, with a higher score indicating greater difficulties with emotion regulation.
Cognitive Emotion Regulation Questionnaire (CERQ)
The CERQ is a measure of cognitive emotion regulation, with 36 items on a Likert scale ranging from 1-5. A higher score indicates greater difficulties with cognitive emotion regulation.
Behavioral Emotion Regulation Questionnaire (BERQ)
The BERQ is a measure of behavioral emotion regulation, with 20 items on a Likert scale ranging from 1-5. A higher score indicates greater difficulties with behavioral emotion regulation.
Emotion Beliefs Questionnaire (EBQ)
The EBQ is a measure of emotion beliefs, with 16 items on a Likert scale ranging from 1-7. A higher score indicates more maladaptive beliefs about emotions.
Perth Alexithymia Questionnaire (PAQ)
The PAQ is a measure of how emotions are perceived and experienced, with 24 items on a Likert scale ranging from 1-7. A higher score indicates greater difficulties related to alexithymia.
Multidimensional Scale of Perceived Social Support (MSPSS)
The MSPSS is a measure of perceived social support, with 12 items on a Likert scale ranging from 1-7. A higher score indicates higher level of perceived social support.
Systemic Clinical Outcome and Routine Evaluation, 15 item version (SCORE-15)
The SCORE-15 is a measure of family function, with 15 items on a Likert scale ranging from 1-5. A higher score indicates greater family function.
Deliberate Self-Harm Inventory - Youth version (DSHI-Y)
The DSHI-Y is a 7-item measure assessing occurrence, method, frequency of deliberate self-harm. A higher score indicates higher frequency and severity of self-harm. The DSHI-Y will be administered as a clinical interview at baseline, post and follow-up, and as a self-rated measure for weekly assessments.
Revised Children's Anxiety and Depression Scale, short (RCADS-S)
The RCADS-S, a shortened version of the Spence Child Anxiety Scale, is a child self-report measure of anxiety- and depression-related psychopathology. Total range is 0-45, Likert scale ranging from 0-3, with higher values representing a worse outcome.
Beck's Hopelessness Scale (BHS)
The BHS is a measure of hopelessness, with 20 dichotomous "true/false" items. A higher score indicates greater difficulties related to hopelessness.
1-item version of the Perceived Criticism Measure (PCM - 1 item version)
The PCM - 1 item version is a measure of expressed emotion, consisting of one question on a Likert scale ranging from 0-10, about how critical an emotionally important individual is perceived to be by the rater.
Borderline Symptom List Supplement (BSL-Supplement)
The BSL-Supplement is a 11-item measure of self-destructive behaviors. Higher score indicates higher frequency of self-destructive behaviors.
Dialectical Behavior Therapy - Ways of Coping Checklist (DBT-WCCL)
The DBT-WCCL is a measure of use of DBT skills use and dysfunctional ways of coping with emotions. Higher average score in the skills use subscale and lower average scores in the dysfunctional coping subscales indicate greater functional coping.
CRAFFT
CRAFFT is a 9-item screening measure of alcohol and substance use. A higher score indicates greater difficulties related to substance use.
Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a 18-item measure of sleep problems. A higher score indicates greater sleep problems.
The Coping with Children's Negative Emotions Scale - Adolescent Version (CCNES-A)
The CCNES-A is a measure of parental coping responses in response to adolescents' negative emotions. The CCNES-A version used in this trial consists of nine hypothetical scenarios accompanied by six types of responses, rated on a Likert scale ranging from 1-7.
Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 is a measure of depression, with 10 items on a Likert scale ranging from 0-3. Higher score indicates greater depressive symptoms.
Generalized anxiety disorder 7-item scale (GAD-7)
The GAD-7 is a measure of anxiety, with 7 items on a Likert scale ranging from 0-3. Higher score indicates greater anxiety symptoms.
The Work and Social Adjustment Scale, youth version (WSAS-Y) - adolescent and parent versions
WSAS-Y is a measure of impaired functioning in school, everyday life, friends and social life, recreation and hobbies and family and close relationships. The scale generates a global score ranging from 0 to 40, with higher scores indicating greater impairment.
Trimbos/iMTA questionnaire for Costs associated with Psychiatric illness (TIC-P)
The TIC-P is a 37 item measure assessing healthcare and societal resource use, including for example items on healthcare resource use, medications, school absenteeism, and parental productivity loss. In the present trial no health economic evaluations will be conducted. Rather this instrument is included to gain feasibility data in preparation of a planned larger randomized controlled trial. Therefore, no data on TiC-P will be reported in this trial.
Child Health Utility 9D (CHU-9D)
The CHU-9D is a measure of health related quality of life, with 9 items on a Likert scale ranging from 1-5. A higher score indicates greater health-related quality of life.
Children's Global Assessment Scale (CGAS)
The CGAS is a single item clinician rated 1-100 scale that integrates psychological, social, and academic functioning in children as a measure of psychiatric disturbance. Higher values represent a better outcome.
The Clinical Global Impressions -Severity and Improvement scales (CGI-S; CGI-I)
The CGI-S and CGI-I are clinician rated 1-item scales ranging from 1-7 where higher ratings indicate greater symptom severity (CGI-S), and greater symptom improvement (CGI-I), respectively.

Full Information

First Posted
August 10, 2022
Last Updated
December 30, 2022
Sponsor
Region Stockholm
Collaborators
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT05537623
Brief Title
Preventing Suicide With Safe Alternatives for Teens and Youths (SAFETY)
Acronym
SAFETYF2022
Official Title
Preventing Suicide With Safe Alternatives for Teens and Youths (SAFETY) - A Randomized Controlled Feasibility Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 2, 2022 (Actual)
Primary Completion Date
October 2, 2024 (Anticipated)
Study Completion Date
December 2, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Stockholm
Collaborators
Karolinska Institutet

4. Oversight

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

5. Study Description

Brief Summary
Suicide is the leading cause of death in the age span 10-19 years in Sweden. The most robust predictor of future suicide attempt and suicide death is prior suicide attempt. Yet, most youths presenting with suicidal behavior to the Child and Adolescent Mental Health Services (CAMHS) in Stockholm, Sweden are not offered evidence-based care directly targeting suicide risk. Safe Alternatives for Teens and Youths (SAFETY) is a novel scalable suicide prevention program designed to fill this critical gap. SAFETY is a cognitive behavioral family treatment incorporating elements from Dialectical Behavior Therapy and Multisystemic Therapy. SAFETY has shown promise in reducing suicide attempts in two small-N trials. In a randomized controlled feasibility trial, the investigators will examine the feasibility of SAFETY and an active control condition named Supportive Therapy at post-treatment, 3 and 12 months after treatment on youth suicidal behavior. Evaluations of feasibility, acceptability, and safety based on data from this pilot trial will guide and inform the design of a full-scale randomized controlled trial.
Detailed Description
Research questions: Is it feasible (operationalized as participation in treatment, completed homework assignments, reported adverse events) to offer SAFETY to youths with suicidal behavior and their caregivers within the CAMHS? Is it feasible (operationalized as participation in treatment, completed homework assignments, reported adverse events) to offer Supportive Therapy as an active control treatment to youths with suicidal behavior and their caregivers within the CAMHS? Is the planned procedure and design (recruitment, blinded assessors, randomization and data attrition) of the study feasible? What are the proportions of suicidal behavior in the group randomized to SAFETY group and the group randomized to Supportive Therapy, respectively? Is participation in SAFETY and Supportive Therapy associated with improved emotion regulation, perceived social support, and family function, and how large are the effects (suggested treatment processes)? Is participation in SAFETY and Supportive Therapy associated with improvements in nonsuicidal self-injury, depression, anxiety, and other outcomes, and how large are the effects (outcomes)? How do the youths and caregivers experience participation in SAFETY and Supportive Therapy, respectively?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide and Self-harm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Safe Alternatives for Teens and Youths (SAFETY)
Arm Type
Experimental
Arm Description
SAFETY is a transdiagnostic cognitive-behavioral family treatment informed by Dialectical Behavior Therapy (DBT) and Multisystemic Therapy (MST). The twelve week long treatment is principle based, structured in phases, and individually tailored based on a cognitive-behavioral fit analysis that specifies key risk and protective processes. Each session contains one individual component for youth and parents respectively, and one family component where youth and parents work together with therapists to practice skills identified as critical for preventing future suicidal behavior. Treatment targets are arranged in a SAFETY Pyramid, consisting of (a) safe settings; (b) safe people; (c) safe activities and actions; (d) safe thought; and (e) safe stress reactions, emphasizing strengthening protective support and validation within the family and/or social environment surrounding the youth.
Arm Title
Supportive Therapy
Arm Type
Active Comparator
Arm Description
Supportive Therapy is a manualized client-centered therapy. The Supportive Therapy will be adapted to match SAFETY to control for nonspecific treatment factors such as therapist characteristics, time, and treatment exposure. The Supportive Therapy program consists of twelve weekly individual sessions with the youth, focusing on the therapeutic supporting relationship between the therapist and the youth, and follow-ups with parents. Therapeutic strategies include acceptance and validation, to increase feelings of connectedness and belonging and counteract thwarted belongingness, helplessness, and hopelessness. Cognitive-behavioral techniques (e.g., active modeling, problem-solving training, cognitive restructuring) are not allowed.
Intervention Type
Behavioral
Intervention Name(s)
Safe Alternatives for Teens and Youths (SAFETY)
Intervention Description
Please see description of experimental arm (arm one)
Intervention Type
Behavioral
Intervention Name(s)
Supportive Therapy
Intervention Description
Please see description of active comparator arm (arm two)
Primary Outcome Measure Information:
Title
Number of completed assessments at week 12
Description
Defined as number of completed assessments at end of intervention (week 12)
Time Frame
week 12
Title
Number of completed assessments at 3 months follow-up
Description
Defined as number of completed assessments 3 months after end of intervention
Time Frame
3 months follow-up
Title
Number of completed assessments at 12 months follow-up
Description
Defined as number of completed assessments 12 months after end of intervention
Time Frame
12 months follow-up
Title
The fraction of eligible participants who consent to inclusion and randomization
Description
The fraction of potential participants will be determined as the number of eligible persons compared to the number of randomized persons.
Time Frame
week 12
Title
Compliance
Description
Compliance will be defined as number of completed sessions.
Time Frame
week 12
Title
Credibility/Expectancy Scale (CEQ)
Description
The CEQ is a 6-item measure of treatment credibility and expectancy. Scale points ranges from 0-9 and 0-100%, where a higher score indicates a better outcome.
Time Frame
week 1 (youth and parent reported)
Title
Client Satisfaction Questionnaire (CSQ)
Description
The CSQ-8 is an 8-item self-rated 4-point scale, measuring different aspects of satisfaction with treatment, e.g. perception of quality of treatment, if the treatment adequately addressed their needs and overall satisfaction. Total range is 8 to 32, with higher values indicating higher satisfaction. Mean in total satisfaction scores on the CSQ-8 for each treatment group at end of treatment will be reported.
Time Frame
week 12 (youth and parent reported)
Title
Adverse events
Description
Participants are asked to report and rate the discomfort of the eventual adverse events caused by their participation in the treatment.
Time Frame
week 12 (youth and parent reported)
Title
Columbia Suicide Severity Rating Scale (C-SSRS) as exploratory clinical outcome
Description
The C-SSRS is a 22-item measure assessing the frequency and severity of suicidal ideation, suicidal behaviors, and self-harm. The C-SSRS will be administered as a clinical interview at baseline (week 0).
Time Frame
week 0 (clinician reported)
Title
Columbia Suicide Severity Rating Scale (C-SSRS) as exploratory clinical outcome
Description
See description above (outcome 9). The C-SSRS will be administered as a self-rated measure for weekly assessments during treatment.
Time Frame
once every week during treatment (week 1-11 after baseline; youth reported)
Title
Columbia Suicide Severity Rating Scale (C-SSRS) as exploratory clinical outcome
Description
See description above (outcome 9), The C-SSRS will be administered as a clinical interview.
Time Frame
week 12 (end of treatment; clinician reported)
Title
Columbia Suicide Severity Rating Scale (C-SSRS) as exploratory clinical outcome
Description
See description above (outcome 9), The C-SSRS will be administered as a clinical interview.
Time Frame
3 months after end of treatment (clinician reported)
Title
Columbia Suicide Severity Rating Scale (C-SSRS) as exploratory clinical outcome
Description
See description above (outcome 9), The C-SSRS will be administered as a clinical interview.
Time Frame
12 months after end of treatment (clinician reported)
Secondary Outcome Measure Information:
Title
Difficulties In Emotion Regulation Scale (DERS)
Description
The DERS is a measure of difficulties in emotion regulation, with 36 items rated on a 1-5 Likert scale, with a higher score indicating greater difficulties with emotion regulation.
Time Frame
Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth and parent reported)
Title
Brief 16-item Version of the Difficulties In Emotion Regulation Scale (DERS-16)
Description
DERS-16 is a brief 16-item version of the DERS, see description above, with 16 items rated on a 1-5 Likert scale, with a higher score indicating greater difficulties with emotion regulation.
Time Frame
Change from baseline, once every week during treatment (week 1-11; youth reported)
Title
Cognitive Emotion Regulation Questionnaire (CERQ)
Description
The CERQ is a measure of cognitive emotion regulation, with 36 items on a Likert scale ranging from 1-5. A higher score indicates greater difficulties with cognitive emotion regulation.
Time Frame
Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Title
Behavioral Emotion Regulation Questionnaire (BERQ)
Description
The BERQ is a measure of behavioral emotion regulation, with 20 items on a Likert scale ranging from 1-5. A higher score indicates greater difficulties with behavioral emotion regulation.
Time Frame
Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Title
Emotion Beliefs Questionnaire (EBQ)
Description
The EBQ is a measure of emotion beliefs, with 16 items on a Likert scale ranging from 1-7. A higher score indicates more maladaptive beliefs about emotions.
Time Frame
Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Title
Perth Alexithymia Questionnaire (PAQ)
Description
The PAQ is a measure of how emotions are perceived and experienced, with 24 items on a Likert scale ranging from 1-7. A higher score indicates greater difficulties related to alexithymia.
Time Frame
Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Title
Multidimensional Scale of Perceived Social Support (MSPSS)
Description
The MSPSS is a measure of perceived social support, with 12 items on a Likert scale ranging from 1-7. A higher score indicates higher level of perceived social support.
Time Frame
Change from baseline, once every week during treatment (week 1-11), week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Title
Systemic Clinical Outcome and Routine Evaluation, 15 item version (SCORE-15)
Description
The SCORE-15 is a measure of family function, with 15 items on a Likert scale ranging from 1-5. A higher score indicates greater family function.
Time Frame
Change from baseline, once every week during treatment (week 1-11), week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Title
Deliberate Self-Harm Inventory - Youth version (DSHI-Y)
Description
The DSHI-Y is a 7-item measure assessing occurrence, method, frequency of deliberate self-harm. A higher score indicates higher frequency and severity of self-harm. The DSHI-Y will be administered as a clinical interview at baseline, post and follow-up, and as a self-rated measure for weekly assessments.
Time Frame
Change from baseline, once every week during treatment (week 1-11), week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Title
Revised Children's Anxiety and Depression Scale, short (RCADS-S)
Description
The RCADS-S, a shortened version of the Spence Child Anxiety Scale, is a child self-report measure of anxiety- and depression-related psychopathology. Total range is 0-45, Likert scale ranging from 0-3, with higher values representing a worse outcome.
Time Frame
Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Title
Beck's Hopelessness Scale (BHS)
Description
The BHS is a measure of hopelessness, with 20 dichotomous "true/false" items. A higher score indicates greater difficulties related to hopelessness.
Time Frame
Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth and parent reported)
Title
1-item version of the Perceived Criticism Measure (PCM - 1 item version)
Description
The PCM - 1 item version is a measure of expressed emotion, consisting of one question on a Likert scale ranging from 0-10, about how critical an emotionally important individual is perceived to be by the rater.
Time Frame
Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Title
Borderline Symptom List Supplement (BSL-Supplement)
Description
The BSL-Supplement is a 11-item measure of self-destructive behaviors. Higher score indicates higher frequency of self-destructive behaviors.
Time Frame
Change from baseline, once every week during treatment (week 1-11), week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Title
Dialectical Behavior Therapy - Ways of Coping Checklist (DBT-WCCL)
Description
The DBT-WCCL is a measure of use of DBT skills use and dysfunctional ways of coping with emotions. Higher average score in the skills use subscale and lower average scores in the dysfunctional coping subscales indicate greater functional coping.
Time Frame
Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Title
CRAFFT
Description
CRAFFT is a 9-item screening measure of alcohol and substance use. A higher score indicates greater difficulties related to substance use.
Time Frame
Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
The PSQI is a 18-item measure of sleep problems. A higher score indicates greater sleep problems.
Time Frame
Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Title
The Coping with Children's Negative Emotions Scale - Adolescent Version (CCNES-A)
Description
The CCNES-A is a measure of parental coping responses in response to adolescents' negative emotions. The CCNES-A version used in this trial consists of nine hypothetical scenarios accompanied by six types of responses, rated on a Likert scale ranging from 1-7.
Time Frame
Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (parent reported)
Title
Patient Health Questionnaire-9 (PHQ-9)
Description
The PHQ-9 is a measure of depression, with 10 items on a Likert scale ranging from 0-3. Higher score indicates greater depressive symptoms.
Time Frame
Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (parent reported)
Title
Generalized anxiety disorder 7-item scale (GAD-7)
Description
The GAD-7 is a measure of anxiety, with 7 items on a Likert scale ranging from 0-3. Higher score indicates greater anxiety symptoms.
Time Frame
Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (parent reported)
Title
The Work and Social Adjustment Scale, youth version (WSAS-Y) - adolescent and parent versions
Description
WSAS-Y is a measure of impaired functioning in school, everyday life, friends and social life, recreation and hobbies and family and close relationships. The scale generates a global score ranging from 0 to 40, with higher scores indicating greater impairment.
Time Frame
Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth and parent reported)
Title
Trimbos/iMTA questionnaire for Costs associated with Psychiatric illness (TIC-P)
Description
The TIC-P is a 37 item measure assessing healthcare and societal resource use, including for example items on healthcare resource use, medications, school absenteeism, and parental productivity loss. In the present trial no health economic evaluations will be conducted. Rather this instrument is included to gain feasibility data in preparation of a planned larger randomized controlled trial. Therefore, no data on TiC-P will be reported in this trial.
Time Frame
Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (parent reported)
Title
Child Health Utility 9D (CHU-9D)
Description
The CHU-9D is a measure of health related quality of life, with 9 items on a Likert scale ranging from 1-5. A higher score indicates greater health-related quality of life.
Time Frame
Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Title
Children's Global Assessment Scale (CGAS)
Description
The CGAS is a single item clinician rated 1-100 scale that integrates psychological, social, and academic functioning in children as a measure of psychiatric disturbance. Higher values represent a better outcome.
Time Frame
Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (clinician reported)
Title
The Clinical Global Impressions -Severity and Improvement scales (CGI-S; CGI-I)
Description
The CGI-S and CGI-I are clinician rated 1-item scales ranging from 1-7 where higher ratings indicate greater symptom severity (CGI-S), and greater symptom improvement (CGI-I), respectively.
Time Frame
Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (clinician reported)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Suicidal behavior (defined as suicide attempt, interrupted suicide attempt, aborted suicide attempt, or preparatory behavior) in the last 3 months Age 10-17 years At least one primary caregiver willing to participate in treatment Exclusion Criteria: Symptoms requiring other immediate treatment (e.g. psychosis, severe anorexia nervosa) Ongoing treatment with DBT Individual or life circumstances that could complicate or make treatment participation impossible, or that require immediate intervention (e.g., violence in close relationships; intellectual disability) Insufficient understanding of the Swedish language
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Moa Karemyr, MSc
Phone
+46 72-395 04 43
Email
moa.karemyr@ki.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johan Bjureberg, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stockholm Regional Council
City
Stockholm
ZIP/Postal Code
12177
Country
Sweden
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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Preventing Suicide With Safe Alternatives for Teens and Youths (SAFETY)

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