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

Study Overview
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Brief Summary
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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
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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.

Official Title
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KopOpOuders-PTSD: Randomized Controlled Trial of A Preventive Blended Care Parenting Intervention for Parents With PTSD

Conditions
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Post-traumatic Stress Disorder

Intervention / Treatment
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* Behavioral: KopOpOuders-PTSD


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention: KopOpOuders-PTSD<br>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. | Behavioral: KopOpOuders-PTSD<br>* See arm description<br>* Other names: KopOpOuders for PTSD;|
| No Intervention: Control: No intervention<br>The control group receives no parenting intervention during their participation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 2 months | 
| 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). | 5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 months | 
| 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. | 2 months | 
| 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). | 2 months | 
| 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. | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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post-traumatic stress disorder, parenting, children of parents with mental illness (COPMI), social support