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

Post-traumatic Stress Disorder Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Post-traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

• NCT number: NCT05237999
• Study type: Interventional
• Source: Arkin
• Contact: Laurien Meijer
• Phone: +31205457327
• Email: laurien.meijer@sinaicentrum.nl
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Completion date: December 2024