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Post-traumatic Stress DisorderNCT05237999

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

A study testing KopOpOuders-PTSD in people with Post-traumatic Stress Disorder, run by Arkin at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Post-traumatic Stress Disorder
What is being tested?
KopOpOuders-PTSD
Could I receive a placebo?
No, everyone receives an active treatment
How many people
142 participants
Where
1 siteNetherlands
Study dates
1 May 2022to Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Laurien Meijer contact

+31205457327

laurien.meijer@sinaicentrum.nl

Netherlands1 site, 1 recruiting

  • Sinai Centrum

    Amstelveen, 1186 AM

    Laurien Meijer, +3120 545 7327, laurien.meijer@sinaicentrum.nl

    Kathleen Thomaes

    Recruiting

Other trials in Netherlands

About this study

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

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.

Read the 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.

Being tested
KopOpOuders-PTSD
Keywords
post-traumatic stress disorder, parenting, children of parents with mental illness (COPMI), social support
Medical subject headings
Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KopOpOuders-PTSDBehavioural

    Also called KopOpOuders for PTSD

    See arm description

Study groups in NCT05237999
Study groupRoleWhat they receive
Intervention: KopOpOuders-PTSDExperimentalKopOpOuders-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.
Receives: Behavioral: KopOpOuders-PTSD
Control: No interventionNo interventionThe control group receives no parenting intervention during their participation.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 2 months

  2. 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).

    Measured: 5 hours

Secondary outcomes (4)

  1. 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.

    Measured: 2 months

  2. 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.

    Measured: 2 months

  3. 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).

    Measured: 2 months

  4. 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.

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2022
  2. Study start1 May 2022
  3. Primary completion1 Sep 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Investigator, Outcomes assessor
Enrolment
142 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05237999
Sponsor's protocol ID
KOO-PTSS
Status last verified
Jan 2024
First submitted
3 Feb 2022
Last updated
1 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: After completion of the study, metadata will be made available. Anonymized IPD can be requested by submitting a data request form to the investigators. IPD will only be shared for those participants who provided informed consent for this in advance.

Publications

  • 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.

    PubMed 26279078

  • 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.

    PubMed 29283597

  • 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.

    PubMed 30693071

  • 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.

  • 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.

  • 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.

    PubMed 15792853

  • 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.

    PubMed 24464491

  • 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.

    PubMed 24100080

  • 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.

    PubMed 30506365

  • 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.

    PubMed 22176935

  • 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.

    PubMed 28505032

  • 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.

    PubMed 30068422

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

  • 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.

    PubMed 25964276

  • 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.

    PubMed 33714168

Questions about this trial

What is this clinical trial studying?

A study testing KopOpOuders-PTSD in people with Post-traumatic Stress Disorder, run by Arkin at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Laurien Meijer (+31205457327, laurien.meijer@sinaicentrum.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Alabama Parenting Questionnaire (APQ) (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05237999, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.

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