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

Arkin

Status: Enrolling

Conditions: Post-traumatic Stress Disorder

Treatments: Behavioral: KopOpOuders-PTSD

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05237999

KOO-PTSS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 142 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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142 participants in 2 patient groups

Intervention: KopOpOuders-PTSD

Experimental group

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.

Treatment:

Behavioral: KopOpOuders-PTSD

Control: No intervention

No Intervention group

Description:

The control group receives no parenting intervention during their participation.