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Effectiveness of a Blended Care Parenting Intervention for Parents With PTSD (KopOpOuders-PTSD)

Primary Purpose

Post-traumatic Stress Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
KopOpOuders-PTSD
Sponsored by
Arkin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-traumatic Stress Disorder focused on measuring post-traumatic stress disorder, parenting, children of parents with mental illness (COPMI), social support

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

  • Has current DSM-5 diagnosis of PTSD;
  • Is receiving PTSD treatment of at least three sessions at one of the following Arkin departments: Sinai Centrum, Jellinek, Punt P, NPI, or Arkin BasisGGZ;
  • Has parenting responsibilities for at least one child aged 4-17 (biological or legal relationship not required).

Exclusion Criteria:

A potential subject who meets any of the following criteria will be excluded from participation in this study:

  • Has urgent care needs or (imminent) crisis (e.g. current psychosis, substance detoxification, active suicidality);
  • Is not in contact with children (e.g. due to out of home placement);
  • Is receiving another form of parenting intervention during the participation period;
  • Severe psychological problems or intellectual disability (IQ < 50) are present in children (diagnosis of oppositional-defiant disorder, conduct disorder, psychotic spectrum disorder or personality disorder);
  • Inability to participate in the intervention and/or assessments (e.g., because of intellectual disability (IQ < 75), illiteracy, or insufficient mastery of the Dutch language).

Sites / Locations

  • Sinai CentrumRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention: KopOpOuders-PTSD

Control: No intervention

Arm Description

KopOpOuders-PTSD is a blended care (i.e., partially online and partially in person) intervention that addresses the enhancing of protective factors within the family setting (reducing negative parental self-perceptions; parent-child interaction quality, social support, child adaptive functioning/coping, and child understanding of the parent's illness) from a combination of transdiagnostic and PTSD-specific perspectives. It consists of 8 sessions (5 online self-help modules, 3 in-person sessions with a professional) to be completed in a maximum period of 9 weeks.

The control group receives no parenting intervention during their participation.

Outcomes

Primary Outcome Measures

Alabama Parenting Questionnaire (APQ)
Parenting skills are measured using the caregiver-report version of the Alabama Parenting Questionnaire (APQ; Frick, 1991). The APQ is a 42-item questionnaire with five subscales: positive involvement with children, supervision/monitoring, use of positive discipline techniques, consistency in discipline techniques, and use of corporal punishment. Responses are scored on a five-point Likert scale ranging from 'never' (1) to 'always' (5). APQ total scores range from 42 to 210. We will recode items so that higher scores reflect more positive parenting. The total score will be used for the main analysis and we will perform additional analyses on the separate subscales. We will use the Dutch translation of the APQ (Van Lier & Crijnen, 1999).
Short Parenting Scale for EMA (SPS-EMA)
Parenting behavior is assessed three times a day during two weeks (at baseline and posttest) with an app for ecological momentary assessment (EMA) using eight adapted items from the Parenting Behavior Inventory (PBI; Lovejoy et al., 1999). For this study, we have selected eight items from the PBI, of which four from each subscale (hostile/coercive and supportive/engaged). The wording of these items has been changed slightly to fit with the EMA format (e.g., 'I say mean things to my child that could make him/her feel bad' becomes 'Since the last notification… I have said mean things to my child that could make him/her feel bad'). We have also changed the response scale from seven- to three-point Likert scale: 'Not true' (1), 'Somewhat true' (2), 'Certainly true' (3). We will analyze the total score of the two subscales combined which ranges from 8-24. For this study, we will call this questionnaire the 'Short Parenting Scale for EMA' (SPS-EMA).

Secondary Outcome Measures

Parenting Sense of Competence Scale (PSOCS)
Perceived parenting competence is measured using the Parenting Sense of Competence Scale (PSOCS; Johnston & Mash, 1989). The PSOCS is a 17-item questionnaire comprising two subscales: satisfaction and efficacy. We will use the total score for the main analysis and perform additional analyses on the two subscales. Items are posed as statements (e.g., 'Being a parent makes me tense and anxious'), which are scored for agreement on a six-point Likert scale ranging from 'strongly disagree' (1) to 'strongly agree' (6). PSOCS total scores range from 17 to 102. We will use the Dutch translation of the PSOCS.
Interpersonal Social Support Evaluation List - 12
Parent social support is measured using the abbreviated version of the Interpersonal Social Support Evaluation List (ISEL-12 (72)). The ISEL-12 has 12 items comprising three subscales: appraisal support, belonging support, and tangible support. We will use the total score for our main analysis (research question 4). Items are rated on a four-point scale ranging from 'Definitely false' (1) to 'Definitely true' (4). ISEL-12 total scores range from 12-48, and will be coded so that higher scores indicate more support. The ISEL-12 total score has good psychometric properties (Cohen et al., 1985). We translated the ISEL-12 to Dutch using the back-translation method. We also added two self-made items reflecting aspects of social support we were interested in in light of our intervention: having someone to look after your children (tangible support) and having someone to talk to about worries about your child (appraisal support). These will be analyzed descriptively.
Strengths and Difficulties Questionnaire - Parent Report (SDQ-P)
Child overall psychological problems are measured using parent-report on the Strengths and Difficulties Questionnaire-Parent Report (SDQ-P; Goodman, 1997). The SDQ-P. The SDQ-P comprises five subscales with five items each: hyperactivity/attention deficit, emotional problems, behavioral problems, peer relationship problems, and prosocial behavior. We will use the 'general difficulties' score as our analysis outcome, which aggregates all subscales excluding prosocial behavior (thus comprising 20 items). We will perform additional analyses on the separate subscales. Items are scored on a three-point Likert scale ranging from 'Not true' (0) to 'Certainly true' (2). The 'general difficulties' score ranges from 0-40. We will use the Dutch translation of the SDQ-P (van Widenfelt et al., 2003).
Child and Adolescent Trauma Screener-Caregiver Report (CATS-C)
Child PTSD symptoms are measured using parent-report on the Child and Adolescent Trauma Screener-Caregiver Report (CATS-C; Sachser et al., 2017; Dutch translation: Kooij & Lindauer, 2022). The CATS-C starts with 15 yes/no items about child exposure to DSM-5 A-criterion traumatic events. If the parent reports their child has been exposed to at least one of these events, the questionnaire continues with 16 (age 3-6) or 20 (age 7-17) items about PTSD symptoms. Data on PTSD symptoms are thus only collected if the child has experienced at least one A-criterion traumatic event. PTSD symptom items are rated on a four-point Likert scale ranging from 'Never' (0) to 'Almost always' (3). Interference with life domains is assessd with five yes/no items. We will analyze the total symptom score (range: 0-48 for age 3-6; 0-60 for age 7-17). We will perform additional analyses on the separate subscales. Scores on trauma exposure items will be reported descriptively.

Full Information

First Posted
February 3, 2022
Last Updated
May 23, 2022
Sponsor
Arkin
Collaborators
Sinai Centrum, Trimbos Institute, Arkin Jeugd en Gezin Preventie, Utrecht University
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1. Study Identification

Unique Protocol Identification Number
NCT05237999
Brief Title
Effectiveness of a Blended Care Parenting Intervention for Parents With PTSD (KopOpOuders-PTSD)
Official Title
KopOpOuders-PTSD: Randomized Controlled Trial of A Preventive Blended Care Parenting Intervention for Parents With PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arkin
Collaborators
Sinai Centrum, Trimbos Institute, Arkin Jeugd en Gezin Preventie, Utrecht University

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
KopOpOuders-PTSD is a new preventive blended care intervention for parents with PTSD. The purpose of this study is to evaluate its effectiveness in improving parenting and preventing child mental health problems.
Detailed Description
Rationale: Children of parents with post-traumatic stress disorder (PTSD) are at increased risk of mental health problems, such as depression, anxiety and hyperactivity. They are also more likely than children of healthy parents to be exposed to potential trauma, especially in the family setting (e.g., child maltreatment). Parents with PTSD often experience difficulties in their parenting role (e.g., deficits in effective parenting, sense of parenting incompetence, lack of social support). Research in other mental disorders shows that preventively supporting parents with mental illness in their parenting role decreases mental health problems in children. As of yet, no preventive intervention specifically aimed at parents with PTSD exist. We have therefore adapted an existing preventive online course for parents with mental illness, 'KopOpOuders zelfhulp', into a blended care intervention for parents with PTSD: 'KopOpOuders-PTSD'. This intervention was developed in co-creation with parents with PTSD and their partners. Objective: Main objective: to test the effectiveness of KopOpOuders-PTSD on macro- and micro-level parenting behavior. Secondary objectives: to test the effectiveness of KopOpOuders-PTSD on perceived parenting competence, parents' social support, and child mental health; to test whether intervention effects are moderated by baseline PTSD symptoms. Study design: The study uses a single-blind randomized controlled trial design with three measurement points (pretest, posttest, and follow-up). Data are collected through self-report questionnaires (macro-level) and ecological momentary assessment (EMA; micro-level) using a smartphone app. Study population: 142 adults (71 per condition) receiving PTSD treatment at Arkin (departments Sinai Centrum, NPI, Jellinek, Arkin Basis GGZ), who have parenting responsibilities for one or more children aged 4-17. Intervention (if applicable): The intervention group receives KopOpOuders-PTSD, consisting of 5 online modules and 3 face-to-face sessions, in addition to treatment as usual. The control group does not receive intervention apart from treatment as usual, but can access the online modules of KopOpOuders-PTSD after participation. Main study parameters/endpoints: Main study parameters are mean level change from pretest to posttest in parenting behavior at the macro- and micro-level.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-traumatic Stress Disorder
Keywords
post-traumatic stress disorder, parenting, children of parents with mental illness (COPMI), social support

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized controlled trial comparing KopOpOuders-PTSD to control (no intervention). In the intervention group, participants complete 8 sessions over 9 weeks (5 individual online self-help modules, 3 in-person sessions with a prevention professional) of KopOpOuders-PTSD. In the control group, participants do not receive an intervention (but do get access to the online self-help modules after their participation). In both conditions, PTSD treatment (and other therapies if applicable) continue as normal during and after participation.
Masking
InvestigatorOutcomes Assessor
Masking Description
Assessments will be performed by allocation-blind assessors. The randomization procedure is carried out by a research assistant not involved in assessments, and outcomes are not visible for assessors. Participants are reminded immediately at each contact with an assessor that they are not allowed to discuss whether or not they were in the intervention group.
Allocation
Randomized
Enrollment
142 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention: KopOpOuders-PTSD
Arm Type
Experimental
Arm Description
KopOpOuders-PTSD is a blended care (i.e., partially online and partially in person) intervention that addresses the enhancing of protective factors within the family setting (reducing negative parental self-perceptions; parent-child interaction quality, social support, child adaptive functioning/coping, and child understanding of the parent's illness) from a combination of transdiagnostic and PTSD-specific perspectives. It consists of 8 sessions (5 online self-help modules, 3 in-person sessions with a professional) to be completed in a maximum period of 9 weeks.
Arm Title
Control: No intervention
Arm Type
No Intervention
Arm Description
The control group receives no parenting intervention during their participation.
Intervention Type
Behavioral
Intervention Name(s)
KopOpOuders-PTSD
Other Intervention Name(s)
KopOpOuders for PTSD
Intervention Description
See arm description
Primary Outcome Measure Information:
Title
Alabama Parenting Questionnaire (APQ)
Description
Parenting skills are measured using the caregiver-report version of the Alabama Parenting Questionnaire (APQ; Frick, 1991). The APQ is a 42-item questionnaire with five subscales: positive involvement with children, supervision/monitoring, use of positive discipline techniques, consistency in discipline techniques, and use of corporal punishment. Responses are scored on a five-point Likert scale ranging from 'never' (1) to 'always' (5). APQ total scores range from 42 to 210. We will recode items so that higher scores reflect more positive parenting. The total score will be used for the main analysis and we will perform additional analyses on the separate subscales. We will use the Dutch translation of the APQ (Van Lier & Crijnen, 1999).
Time Frame
2 months
Title
Short Parenting Scale for EMA (SPS-EMA)
Description
Parenting behavior is assessed three times a day during two weeks (at baseline and posttest) with an app for ecological momentary assessment (EMA) using eight adapted items from the Parenting Behavior Inventory (PBI; Lovejoy et al., 1999). For this study, we have selected eight items from the PBI, of which four from each subscale (hostile/coercive and supportive/engaged). The wording of these items has been changed slightly to fit with the EMA format (e.g., 'I say mean things to my child that could make him/her feel bad' becomes 'Since the last notification… I have said mean things to my child that could make him/her feel bad'). We have also changed the response scale from seven- to three-point Likert scale: 'Not true' (1), 'Somewhat true' (2), 'Certainly true' (3). We will analyze the total score of the two subscales combined which ranges from 8-24. For this study, we will call this questionnaire the 'Short Parenting Scale for EMA' (SPS-EMA).
Time Frame
5 hours
Secondary Outcome Measure Information:
Title
Parenting Sense of Competence Scale (PSOCS)
Description
Perceived parenting competence is measured using the Parenting Sense of Competence Scale (PSOCS; Johnston & Mash, 1989). The PSOCS is a 17-item questionnaire comprising two subscales: satisfaction and efficacy. We will use the total score for the main analysis and perform additional analyses on the two subscales. Items are posed as statements (e.g., 'Being a parent makes me tense and anxious'), which are scored for agreement on a six-point Likert scale ranging from 'strongly disagree' (1) to 'strongly agree' (6). PSOCS total scores range from 17 to 102. We will use the Dutch translation of the PSOCS.
Time Frame
2 months
Title
Interpersonal Social Support Evaluation List - 12
Description
Parent social support is measured using the abbreviated version of the Interpersonal Social Support Evaluation List (ISEL-12 (72)). The ISEL-12 has 12 items comprising three subscales: appraisal support, belonging support, and tangible support. We will use the total score for our main analysis (research question 4). Items are rated on a four-point scale ranging from 'Definitely false' (1) to 'Definitely true' (4). ISEL-12 total scores range from 12-48, and will be coded so that higher scores indicate more support. The ISEL-12 total score has good psychometric properties (Cohen et al., 1985). We translated the ISEL-12 to Dutch using the back-translation method. We also added two self-made items reflecting aspects of social support we were interested in in light of our intervention: having someone to look after your children (tangible support) and having someone to talk to about worries about your child (appraisal support). These will be analyzed descriptively.
Time Frame
2 months
Title
Strengths and Difficulties Questionnaire - Parent Report (SDQ-P)
Description
Child overall psychological problems are measured using parent-report on the Strengths and Difficulties Questionnaire-Parent Report (SDQ-P; Goodman, 1997). The SDQ-P. The SDQ-P comprises five subscales with five items each: hyperactivity/attention deficit, emotional problems, behavioral problems, peer relationship problems, and prosocial behavior. We will use the 'general difficulties' score as our analysis outcome, which aggregates all subscales excluding prosocial behavior (thus comprising 20 items). We will perform additional analyses on the separate subscales. Items are scored on a three-point Likert scale ranging from 'Not true' (0) to 'Certainly true' (2). The 'general difficulties' score ranges from 0-40. We will use the Dutch translation of the SDQ-P (van Widenfelt et al., 2003).
Time Frame
2 months
Title
Child and Adolescent Trauma Screener-Caregiver Report (CATS-C)
Description
Child PTSD symptoms are measured using parent-report on the Child and Adolescent Trauma Screener-Caregiver Report (CATS-C; Sachser et al., 2017; Dutch translation: Kooij & Lindauer, 2022). The CATS-C starts with 15 yes/no items about child exposure to DSM-5 A-criterion traumatic events. If the parent reports their child has been exposed to at least one of these events, the questionnaire continues with 16 (age 3-6) or 20 (age 7-17) items about PTSD symptoms. Data on PTSD symptoms are thus only collected if the child has experienced at least one A-criterion traumatic event. PTSD symptom items are rated on a four-point Likert scale ranging from 'Never' (0) to 'Almost always' (3). Interference with life domains is assessd with five yes/no items. We will analyze the total symptom score (range: 0-48 for age 3-6; 0-60 for age 7-17). We will perform additional analyses on the separate subscales. Scores on trauma exposure items will be reported descriptively.
Time Frame
2 weeks
Other Pre-specified Outcome Measures:
Title
PTSD Checklist for DSM-5
Description
PTSD symptoms are measured at baseline using the PTSD Checklist for DSM-5 (PCL-5; Blevins et al., 2015). The PCL-5 comprises 20 items describing PTSD symptoms rated on a five-point Likert scale ranging from 'Not at all' (0) to 'Extremely' (4). The PCL-5 comprises four subscales corresponding to DSM-5 PTSD symptom clusters (intrusion, avoidance, negative alterations in mood and cognitions, and hyperarousal). We will use the PCL-5 total score (ranging from 0-80) as a moderator variable. We will use the Dutch translation of the PCL-5 (Boeschoten et al., 2014).
Time Frame
1 month
Title
Life Events Questionnaire for DSM-5 (LEC-5)
Description
Trauma exposure is measured at baseline using the Life Events Questionnaire for DSM-5 (LEC-5; Weathers et al., 2013). The LEC-5 comprises 17 items which describe DSM-5 A-criterion traumatic events (e.g., 'Fire or explosion'). Participants note for each event on a scale with 6 options whether they were directly or indirectly (i.e., as a witness, learning about it happening to someone close to them, or as part of their job) exposed to it. In case of multiple trauma exposures, the participant is asked to indicate which event bothers them the most. This event is called the 'index trauma' and will be used to determine trauma type in this study. The Dutch translation of the LEC-5 is used (Boeschoten et al., 2014).
Time Frame
Lifetime
Title
Outcome Questionnaire-45 (OQ-45)
Description
General psychosocial functioning is measured as part of the ROM at Arkin using the Outcome Questionnaire-45 (OQ-45; Lambert et al., 1996). We will use the closest ROM measurement before baseline. The OQ-45 comprises 45 items, divided into three subscales: symptom distress (25 items, measures symptoms of depression, anxiety and substance abuse), interpersonal relations (11 items, measures relational functioning) and social role (9 items, measures functioning in school, work and/or leisure). Items are scored on a 5-point Likert scale ranging from 'Never' (0) to 'Always' (4). We will descriptively report the OQ-45 total score, which ranges from 0-180.
Time Frame
1 week
Title
Demographic information
Description
To provide information on the demographic background of the sample, participants complete a short demographic questionnaire (DQ) at baseline with items about themselves and their children.
Time Frame
Lifetime
Title
Intervention adherence and satisfaction
Description
For participants in the intervention condition, results on intervention adherence (completion of online modules; attendance of face-to-face sessions; and use of PTSD-specific content in the online library) will be reported descriptively. Furthermore, intervention group participants complete a short satisfaction questionnaire (SQ) at posttest. The SQ contains closed-ended and open-ended questions on aspects of the intervention, and invites participants to provide suggestions for improvement. Results will be reported descriptively in the publication of the current study and will be used for future improvement of the intervention.
Time Frame
10 weeks
Title
Short Form PTSD Checklist for DSM-5 (SF-PCL-5)
Description
PTSD symptoms are assessed in the EMA app using a short-form version of the PTSD Checklist for DSM-5 (PCL-5) with one item for each of the four symptom clusters (SF-PCL-5; Zuromski et al., 2019). Each item is rated for past-month frequency on a five-point Likert scale ranging from 'Not at all' (0) to 'Extremely' (4). The instruction of the SF-PCL-5 will be changed to fit with the EMA format. That is, participants are asked to report on their symptoms during the current part of the day (morning/afternoon/evening). Scores range from 0-16.
Time Frame
5 hours
Title
Sleep Quality Rating
Description
Sleep quality will only be assessed in the morning EMA assessments, using a single item ('How well did you sleep last night?') answered on a 10-point scale.
Time Frame
1 day
Title
Situational Context
Description
To assess the situational context, each EMA questionnaire starts with two situation items (Where are you; Who are you with), answered using multiple choice.
Time Frame
5 hours
Title
Distress Rating
Description
To assess current levels of distress, each EMA questionnaire contains a single item ('How much distress are you currently feeling?'), answered on a 10-point scale.
Time Frame
5 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: Has current DSM-5 diagnosis of PTSD; Is receiving PTSD treatment of at least three sessions at one of the following Arkin departments: Sinai Centrum, Jellinek, Punt P, NPI, or Arkin BasisGGZ; Has parenting responsibilities for at least one child aged 4-17 (biological or legal relationship not required). Exclusion Criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: Has urgent care needs or (imminent) crisis (e.g. current psychosis, substance detoxification, active suicidality); Is not in contact with children (e.g. due to out of home placement); Is receiving another form of parenting intervention during the participation period; Severe psychological problems or intellectual disability (IQ < 50) are present in children (diagnosis of oppositional-defiant disorder, conduct disorder, psychotic spectrum disorder or personality disorder); Inability to participate in the intervention and/or assessments (e.g., because of intellectual disability (IQ < 75), illiteracy, or insufficient mastery of the Dutch language).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laurien Meijer
Phone
+31205457327
Email
laurien.meijer@sinaicentrum.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Thomaes
Organizational Affiliation
Sinai Centrum
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sinai Centrum
City
Amstelveen
ZIP/Postal Code
1186 AM
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurien Meijer
Phone
+3120 545 7327
Email
laurien.meijer@sinaicentrum.nl
First Name & Middle Initial & Last Name & Degree
Kathleen Thomaes
First Name & Middle Initial & Last Name & Degree
Matthijs Blankers
First Name & Middle Initial & Last Name & Degree
Catrin Finkenauer
First Name & Middle Initial & Last Name & Degree
Anouk De Gee
First Name & Middle Initial & Last Name & Degree
Jeannet Kramer

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
After completion of the study, metadata will be made available. Anonymized IPD can be requested by submitting a data request form to the investigators. IPD will only be shared for those participants who provided informed consent for this in advance.
IPD Sharing Time Frame
Anticipated in 2025, for at least 15 years.
IPD Sharing Access Criteria
Data request form
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Effectiveness of a Blended Care Parenting Intervention for Parents With PTSD (KopOpOuders-PTSD)

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