KOPPeling: Help From Your Own Circle

NCT ID: NCT05829408

Last Updated: 2024-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-23

Study Completion Date

2026-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Children of Parents With a Mental Illness (COPMI)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention (KOPPeling)

In this arm participants directly receive the KOPPeling intervention.

Group Type OTHER

KOPPeling

Intervention Type BEHAVIORAL

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

Waiting list

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

Group Type OTHER

KOPPeling

Intervention Type BEHAVIORAL

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

Interventions

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KOPPeling

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Accare

OTHER

Sponsor Role collaborator

WIJ Groningen

UNKNOWN

Sponsor Role collaborator

GGZ Friesland

OTHER

Sponsor Role collaborator

Amaryllis Leeuwarden

UNKNOWN

Sponsor Role collaborator

Hanzehogeschool Groningen

UNKNOWN

Sponsor Role collaborator

Lentis

UNKNOWN

Sponsor Role collaborator

University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frederike Jörg, Dr.

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

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UMC Groningen

Groningen, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Lisa Maeder, M.Sc.

Role: CONTACT

+31686550763

Frederike Jörg, Dr.

Role: CONTACT

Facility Contacts

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Lisa Maeder, M.Sc.

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 19807604 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12601558 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14689260 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18509902 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24951511 (View on PubMed)

Other Identifiers

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10196

Identifier Type: -

Identifier Source: org_study_id

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