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

NCT05237999 | Unknown

• 1 other identifier: KOO-PTSS
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-traumatic Stress Disorder

Keywords

post-traumatic stress disorder; parenting; children of parents with mental illness (COPMI); social support

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Parenting Sense of Competence Scale (PSOCS)

  2 months

• Interpersonal Social Support Evaluation List - 12

  2 months

• Strengths and Difficulties Questionnaire - Parent Report (SDQ-P)

  2 months

• Child and Adolescent Trauma Screener-Caregiver Report (CATS-C)

  2 weeks

Other Outcomes (9)

• PTSD Checklist for DSM-5

  1 month

• Life Events Questionnaire for DSM-5 (LEC-5)

  Lifetime

• Outcome Questionnaire-45 (OQ-45)

  1 week

Study Arms (2)

Intervention: KopOpOuders-PTSD

EXPERIMENTAL

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

Control: No intervention

NO INTERVENTION

The control group receives no parenting intervention during their participation.

Interventions

KopOpOuders-PTSD BEHAVIORAL

See arm description

Also known as: KopOpOuders for PTSD

Intervention: KopOpOuders-PTSD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Arkin: lead
• Sinai Centrum: collaborator
• Trimbos Institute: collaborator
• Arkin Jeugd en Gezin Preventie: collaborator
• Utrecht University: collaborator

Study Sites (1)

Sinai Centrum

Amstelveen, 1186 AM, Netherlands

RECRUITING

Related Publications (16)

• Bowers ME, Yehuda R. Intergenerational Transmission of Stress in Humans. Neuropsychopharmacology. 2016 Jan;41(1):232-44. doi: 10.1038/npp.2015.247. Epub 2015 Aug 17.

  PMID: 26279078 BACKGROUND

• Chesmore AA, Piehler TF, Gewirtz AH. PTSD as a moderator of a parenting intervention for military families. J Fam Psychol. 2018 Feb;32(1):123-133. doi: 10.1037/fam0000366. Epub 2017 Dec 28.

  PMID: 29283597 BACKGROUND

• Christie H, Hamilton-Giachritsis C, Alves-Costa F, Tomlinson M, Halligan SL. The impact of parental posttraumatic stress disorder on parenting: a systematic review. Eur J Psychotraumatol. 2019 Jan 14;10(1):1550345. doi: 10.1080/20008198.2018.1550345. eCollection 2019.

  PMID: 30693071 BACKGROUND

• Chun CA. The Expression of Posttraumatic Stress Symptoms in Daily Life: A Review of Experience Sampling Methodology and Daily Diary Studies. Journal of Psychopathology and Behavioral Assessment. 2016; 38(3): 406-420.

  BACKGROUND

• Hosman CMH, van Doesum KTM, van Santvoort F. Prevention of emotional problems and psychiatric risks in children of parents with a mental illness in the Netherlands: I. The scientific basis to a comprehensive approach. Australian E-Journal for the Advancement of Mental Health. 2006; 8(3): 250-263.

  BACKGROUND

• Jones TL, Prinz RJ. Potential roles of parental self-efficacy in parent and child adjustment: a review. Clin Psychol Rev. 2005 May;25(3):341-63. doi: 10.1016/j.cpr.2004.12.004.

  PMID: 15792853 BACKGROUND

• Lambert JE, Holzer J, Hasbun A. Association between parents' PTSD severity and children's psychological distress: a meta-analysis. J Trauma Stress. 2014 Feb;27(1):9-17. doi: 10.1002/jts.21891. Epub 2014 Jan 24.

  PMID: 24464491 BACKGROUND

• Leen-Feldner EW, Feldner MT, Knapp A, Bunaciu L, Blumenthal H, Amstadter AB. Offspring psychological and biological correlates of parental posttraumatic stress: review of the literature and research agenda. Clin Psychol Rev. 2013 Dec;33(8):1106-33. doi: 10.1016/j.cpr.2013.09.001. Epub 2013 Sep 12.

  PMID: 24100080 BACKGROUND

• Montgomery E, Just-Ostergaard E, Jervelund SS. Transmitting trauma: a systematic review of the risk of child abuse perpetrated by parents exposed to traumatic events. Int J Public Health. 2019 Mar;64(2):241-251. doi: 10.1007/s00038-018-1185-4. Epub 2018 Dec 1.

  PMID: 30506365 BACKGROUND

• Siegenthaler E, Munder T, Egger M. Effect of preventive interventions in mentally ill parents on the mental health of the offspring: systematic review and meta-analysis. J Am Acad Child Adolesc Psychiatry. 2012 Jan;51(1):8-17.e8. doi: 10.1016/j.jaac.2011.10.018. Epub 2011 Dec 3.

  PMID: 22176935 BACKGROUND

• Thanhauser M, Lemmer G, de Girolamo G, Christiansen H. Do preventive interventions for children of mentally ill parents work? Results of a systematic review and meta-analysis. Curr Opin Psychiatry. 2017 Jul;30(4):283-299. doi: 10.1097/YCO.0000000000000342.

  PMID: 28505032 BACKGROUND

• Thomas JC, Letourneau N, Campbell TS, Giesbrecht GF; Apron Study Team. Social buffering of the maternal and infant HPA axes: Mediation and moderation in the intergenerational transmission of adverse childhood experiences. Dev Psychopathol. 2018 Aug;30(3):921-939. doi: 10.1017/S0954579418000512.

  PMID: 30068422 BACKGROUND

• van Doesum, K. T. Databank effectieve jeugdinterventies: Beschrijving 'KopOpOuders'. Nederlands Jeugdinstituut. 2020.

  BACKGROUND

• van Ee E, Kleber RJ, Jongmans MJ. Relational Patterns Between Caregivers With PTSD and Their Nonexposed Children: A Review. Trauma Violence Abuse. 2016 Apr;17(2):186-203. doi: 10.1177/1524838015584355. Epub 2015 May 11.

  PMID: 25964276 BACKGROUND

• Wang Y, Chung MC, Wang N, Yu X, Kenardy J. Social support and posttraumatic stress disorder: A meta-analysis of longitudinal studies. Clin Psychol Rev. 2021 Apr;85:101998. doi: 10.1016/j.cpr.2021.101998. Epub 2021 Mar 4.

  PMID: 33714168 BACKGROUND

• Meijer L, Finkenauer C, Blankers M, de Gee A, Kramer J, Shields-Zeeman L, Thomaes K. Study protocol: development and randomized controlled trial of a preventive blended care parenting intervention for parents with PTSD. BMC Psychiatry. 2023 Feb 10;23(1):102. doi: 10.1186/s12888-023-04548-8.

  PMID: 36765312 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Kathleen Thomaes

  Sinai Centrum

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurien Meijer

CONTACT

+31205457327; laurien.meijer@sinaicentrum.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: February 14, 2022
• Study Start: May 1, 2022
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Anticipated in 2025, for at least 15 years.
• Access Criteria: Data request form

Locations

NL (1)