KOPPeling: Help From Your Own Circle

Overview

The goal of this randomized clinical trial is to test the effectiveness of the KOPPeling intervention that aims at unburdening COPMI (Children Of Parents with a Mental Illness). COPMI are at risk of overtaking the tasks of their parents when their parents are unable to fulfil such due to their psychiatric condition. By overtaking tasks and the urge to always take care of their parents, COPMI often do not participate in outdoor activities, which are necessary for their socio-emotional development. Moreover, insufficient socio-emotional development and parentification are risk factors for the development of psychiatric conditions. KOPPeling is an intervention for COPMI families that focuses on activating the social networks of the families. Within KOPPeling, a strategic plan will be developed and carried out with the goal of receiving support from the social network that will overtake tasks of the family to unburden COPMI. This study aims to answer the following questions: 1. To what extent does KOPPeling lead to an increase in Quality of Life (QoL) among COPMI? 2. To what extent does KOPPeling lead to an increase in mental health among COPMI? 3. To what extent does KOPPeling lead to a reduction of parenting stress among COPMI parents? 4. To what extent does KOPPeling lead to an increase in outdoor activities among COPMI? 5. How does KOPPeling affect the feelings of guilt of COPMI when engaging in outdoor activities? 6. What pre-conditions are needed to make KOPPeling widely applicable? 7. What are the long-term effects of KOPPeling on the QoL and psychological problems among COPMI and parental stress among COPMI parents? Participants will participate in the ten-to-twelve-week long KOPPeling intervention. Researchers will compare the intervention group with a waiting list control group to test the effect of KOPPeling on the QoL and mental health of COPMI and parental stress of parents.

Interventions

• Behavioral KOPPeling
  KOPPeling lasts ten to twelve weeks and will be administered by health care professionals.

Primary outcome measures

• Change in Quality of Life (QoL) of COPMI [Time frame: At T0 (baseline, start of intervention), T1 (end of intervention) and T2 (three months after the end of intervention), total time frame: 22 to 24 weeks]

Secondary outcome measures (6)

• Change in mental health of COPMI [Time frame: At T0 (baseline, start of intervention), T1 (end of intervention) and T2 (three months after the end of intervention), total time frame: 22 to 24 weeks]
• Change in parental stress of COPMI parents [Time frame: At T0 (baseline, start of intervention), T1 (end of intervention) and T2 (three months after the end of intervention), total time frame: 22 to 24 weeks]
• Change in engagement in outdoor activities of COPMI [Time frame: For one week after the start of the intervention and one week before the end of the intervention]
• Change in guilt of COPMI when engaging in outdoor activities [Time frame: For one week after the start of the intervention and one week before the end of the intervention]
• Experiences of the social networks made with KOPPeling [Time frame: At the end of the intervention (ten to twelve weeks after the start of the intervention)]
• Promoting and hindering factors of making KOPPeling a widely applicable intervention [Time frame: At the end of the intervention (ten to twelve weeks after the start of the intervention)]

Eligibility criteria

Inclusion criteria

• The family has children aged 0-18 living at home
• The parental disorder influences the parent's (or parents') ability to carry out several important parental tasks, placing their offspring at risk of taking over these tasks

Exclusion criteria

\- The family has no existing social network

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

Netherlands · 1 center

• UMC Groningen — Groningen

Publications

• Ravens-Sieberer U, Gosch A, Rajmil L, Erhart M, Bruil J, Duer W, Auquier P, Power M, Abel T, Czemy L, Mazur J, Czimbalmos A, Tountas Y, Hagquist C, Kilroe J, Kidscreen Group E. KIDSCREEN-52 quality-of-life measure for children and adolescents. Expert Rev Pharmacoecon Outcomes Res. 2005 Jun;5(3):353-64. doi: 10.1586/14737167.5.3.353. PMID 19807604
• Muris P, Meesters C, van den Berg F. The Strengths and Difficulties Questionnaire (SDQ)--further evidence for its reliability and validity in a community sample of Dutch children and adolescents. Eur Child Adolesc Psychiatry. 2003 Jan;12(1):1-8. doi: 10.1007/s00787-003-0298-2. PMID 12601558
• van Widenfelt BM, Goedhart AW, Treffers PD, Goodman R. Dutch version of the Strengths and Difficulties Questionnaire (SDQ). Eur Child Adolesc Psychiatry. 2003 Dec;12(6):281-9. doi: 10.1007/s00787-003-0341-3. PMID 14689260
• Shiffman S, Stone AA, Hufford MR. Ecological momentary assessment. Annu Rev Clin Psychol. 2008;4:1-32. doi: 10.1146/annurev.clinpsy.3.022806.091415. PMID 18509902
• Fleuren MA, Paulussen TG, Van Dommelen P, Van Buuren S. Towards a measurement instrument for determinants of innovations. Int J Qual Health Care. 2014 Oct;26(5):501-10. doi: 10.1093/intqhc/mzu060. Epub 2014 Jun 20. PMID 24951511

Identifiers

NCT: NCT05829408 · 10196

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗