KOPPeling: Help From Your Own Circle

NCT05829408 | Recruiting

• 1 other identifier: 10196
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.To what extent does KOPPeling lead to an increase in Quality of Life (QoL) among COPMI?
2. 2.To what extent does KOPPeling lead to an increase in mental health among COPMI?
3. 3.To what extent does KOPPeling lead to a reduction of parenting stress among COPMI parents?
4. 4.To what extent does KOPPeling lead to an increase in outdoor activities among COPMI?
5. 5.How does KOPPeling affect the feelings of guilt of COPMI when engaging in outdoor activities?
6. 6.What pre-conditions are needed to make KOPPeling widely applicable?
7. 7.What are the long-term effects of KOPPeling on the QoL and psychological problems among COPMI and parental stress among COPMI parents?

Conditions

Children of Parents With a Mental Illness (COPMI)

Keywords

COPMI; Prevention; Social participation; Mental illness

Outcome Measures

Primary Outcomes (1)

• Change in Quality of Life (QoL) of COPMI

  QoL of COPMI, which will be assessed with the KIDSCREEN-27. The KIDSCREEN-27 includes 27 items measuring five dimensions of QoL on a Rasch scale including: 1) physical well-being, 2) psychological well-being, 3) autonomy and parent relation, 4) peers and social support, and 5) school environments. Each item is measured on a five-point Likert scale. Some items are negatively formulated through which the item scores need to be reversed. The overall score is calculated by summing up all the items. Therefore, higher scores indicate higher QoL.

  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 Outcomes (6)

• Change in mental health of COPMI

  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

  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

  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

  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

  At the end of the intervention (ten to twelve weeks after the start of the intervention)

Study Arms (2)

Intervention (KOPPeling)

OTHER

In this arm participants directly receive the KOPPeling intervention.

Behavioral: KOPPeling

Waiting list

OTHER

In this arm participants are placed on a waiting list (ten to twelve weeks) before receiving the KOPPeling intervention.

Behavioral: KOPPeling

Interventions

KOPPeling BEHAVIORAL

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

Intervention (KOPPeling); Waiting list

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- The family has no existing social network

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Accare: collaborator
• WIJ Groningen: collaborator
• GGZ Friesland: collaborator
• Amaryllis Leeuwarden: collaborator
• Hanzehogeschool Groningen: collaborator
• Lentis: collaborator

Study Sites (1)

UMC Groningen

Groningen, Netherlands

RECRUITING

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Mental Disorders

Study Officials

• Frederike Jörg, Dr.

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Maeder, M.Sc.

CONTACT

+31686550763; l.maeder@umcg.nl

Frederike Jörg, Dr.

CONTACT

f.jorg@umcg.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: April 25, 2023
• Study Start: April 23, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)