Clinical trial NCT05237999: 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
Overall status: RECRUITING
Phase: NA
Conditions: Post-traumatic Stress Disorder
Keywords: post-traumatic stress disorder
parenting
children of parents with mental illness (COPMI)
social support
Lead sponsor: Arkin
Sponsor class: INDUSTRY
Collaborators: name: Sinai Centrum
name: Trimbos Institute
name: Arkin Jeugd en Gezin Preventie
name: Utrecht University
First posted: 2022-02-14
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Alabama Parenting Questionnaire (APQ)
timeFrame: 2 months
measure: Short Parenting Scale for EMA (SPS-EMA)
timeFrame: 5 hours
Secondary outcomes:
measure: Parenting Sense of Competence Scale (PSOCS)
timeFrame: 2 months
measure: Interpersonal Social Support Evaluation List - 12
timeFrame: 2 months
measure: Strengths and Difficulties Questionnaire - Parent Report (SDQ-P)
timeFrame: 2 months
measure: Child and Adolescent Trauma Screener-Caregiver Report (CATS-C)
timeFrame: 2 weeks
Other outcomes:
measure: PTSD Checklist for DSM-5
timeFrame: 1 month
measure: Life Events Questionnaire for DSM-5 (LEC-5)
timeFrame: Lifetime
measure: Outcome Questionnaire-45 (OQ-45)
timeFrame: 1 week
measure: Demographic information
timeFrame: Lifetime
measure: Intervention adherence and satisfaction
timeFrame: 10 weeks
measure: Short Form PTSD Checklist for DSM-5 (SF-PCL-5)
timeFrame: 5 hours
measure: Sleep Quality Rating
timeFrame: 1 day
measure: Situational Context
timeFrame: 5 hours
measure: Distress Rating
timeFrame: 5 hours
Locations:
city: Amstelveen
country: Netherlands
facility: Sinai Centrum
Study officials:
affiliation: Sinai Centrum
name: Kathleen Thomaes
role: PRINCIPAL_INVESTIGATOR
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