Children of Parents With a Mental Illness (COPMI)NCT05829408
KOPPeling: Help From Your Own Circle
A study testing KOPPeling in people with Children of Parents With a Mental Illness (COPMI), run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Children of Parents With a Mental Illness (COPMI)
- What is being tested?
- KOPPeling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteNetherlands
- Study dates
- 23 Apr 2024to 31 Aug 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- The family has no existing social network
Trial locations and contacts
1 site in 1 country.
Frederike Jörg, Dr. contact
Netherlands1 site, 1 recruiting
- Recruiting
UMC Groningen
Groningen
Lisa Maeder, M.Sc., l.maeder@umcg.nl
About this study
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.
Read more
This study aims to answer the following questions:
- To what extent does KOPPeling lead to an increase in Quality of Life (QoL) among COPMI?
- To what extent does KOPPeling lead to an increase in mental health among COPMI?
- To what extent does KOPPeling lead to a reduction of parenting stress among COPMI parents?
- To what extent does KOPPeling lead to an increase in outdoor activities among COPMI?
- How does KOPPeling affect the feelings of guilt of COPMI when engaging in outdoor activities?
- What pre-conditions are needed to make KOPPeling widely applicable?
- 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.
- Being tested
- KOPPeling
- Keywords
- COPMI, Prevention, Social participation, Mental illness
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KOPPelingBehavioural
KOPPeling lasts ten to twelve weeks and will be administered by health care professionals.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (KOPPeling) | Other | In this arm participants directly receive the KOPPeling intervention. Receives: Behavioral: KOPPeling |
| Waiting list | Other | In this arm participants are placed on a waiting list (ten to twelve weeks) before receiving the KOPPeling intervention. Receives: Behavioral: KOPPeling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The mental health of COPMI, which will be assessed with the Strengths and Difficulties Questionnaire (SDQ). The SDQ consists out of 25 items (five scales of five items each) including the following subscales: 1) emotional symptoms, 2) conduct problems, 3) hyperactivity/inattention, 4) peer relationships problem and 5) prosocial behaviour.
Each attribute is scored on a zero to ten scale. While a score of 0 is the best outcome concerning the emotional, conduct, hyperactivity, and peer relationship scale (adding up to a 0 to 40 scale), a score of 10 is the best outcome concerning the pro-social behaviour scale.
Measured: 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
The parental stress of COPMI parents, which will be assessed with the Nijmeegse Ouderlijke Stress Index (NOSI-K). The NOSI-K includes 25-items assessing parental perceived difficulty in child rearing. Each item, which states a parental-stress-related statement, is rated on a five-point Likert scale ranging from 1 (totally disagree) to (totally agree).
Measured: 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
The engagement in outdoor activities will be measured in an ecological momentary assessment.
Measured: 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
The associated guilt of engaging in outdoor activities of COPMI will be assessed in an ecological momentary assessment in which the Guilt and Shame Questionnaire for Adolescents of Parents with a Mental Illness (GSQ-APMI) will be used. The GSQ-APMI includes 10 items. Five items were developed to measure shame and five items to measure guilt. A total score is not applicable as the GSQ-APMI results in two scores: one reflecting feelings of guilt and one reflecting feelings of shame. Higher scores reflect greater feelings of guilt or shame.
Measured: 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
The experiences of the social network with KOPPeling, which will be assessed in a qualitative interview with a purposive sample taken from the social networks of included families.
Measured: 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
The promoting and hindering factors for making the intervention widely applicable, which will be assessed with the Measuring Instrument for Determinants of Innovations (MIDI).
Measured: At the end of the intervention (ten to twelve weeks after the start of the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start23 Apr 2024
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Children of Parents With a Mental Illness (COPMI)Studies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Accare, WIJ Groningen, GGZ Friesland, Amaryllis Leeuwarden, Hanzehogeschool Groningen, Lentis
- Responsible party
- Sponsor
- Investigators
- Frederike Jörg, Dr., Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05829408
- Sponsor's protocol ID
- 10196
- Status last verified
- Jul 2024
- First submitted
- 21 Feb 2023
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 19807604Muris 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.
PubMed 12601558van 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.
PubMed 14689260Shiffman S, Stone AA, Hufford MR. Ecological momentary assessment. Annu Rev Clin Psychol. 2008;4:1-32. doi: 10.1146/annurev.clinpsy.3.022806.091415.
PubMed 18509902Fleuren 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.
PubMed 24951511
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KOPPeling: Help From Your Own Circle
- ClinicalTrials.gov ID
- NCT05829408
- Acronym / sponsor ID
- 10196
- Keywords
- COPMI, Prevention, Social participation, Mental illness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Accare, WIJ Groningen, GGZ Friesland, Amaryllis Leeuwarden, Hanzehogeschool Groningen, Lentis
- Study start
- 23 Apr 2024 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 25 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To what extent does KOPPeling lead to an increase in Quality of Life (QoL) among COPMI?
- To what extent does KOPPeling lead to an increase in mental health among COPMI?
- To what extent does KOPPeling lead to a reduction of parenting stress among COPMI parents?
- To what extent does KOPPeling lead to an increase in outdoor activities among COPMI?
- How does KOPPeling affect the feelings of guilt of COPMI when engaging in outdoor activities?
- What pre-conditions are needed to make KOPPeling widely applicable?
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (KOPPeling) | Other | Behavioral: KOPPelingIn this arm participants directly receive the KOPPeling intervention. |
| Waiting list | Other | Behavioral: KOPPelingIn this arm participants are placed on a waiting list (ten to twelve weeks) before receiving the KOPPeling intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- The family has no existing social network
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KOPPelingKOPPeling lasts ten to twelve weeks and will be administered by health care professionals. | Behavioural | Intervention (KOPPeling), Waiting list |
Primary outcome
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
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.
6 secondary outcomes
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Background: PubMed 19807604Ravens-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.
- Background: PubMed 12601558Muris 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.
- Background: PubMed 14689260van 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.
- Background: PubMed 18509902Shiffman S, Stone AA, Hufford MR. Ecological momentary assessment. Annu Rev Clin Psychol. 2008;4:1-32. doi: 10.1146/annurev.clinpsy.3.022806.091415.
- Background: PubMed 24951511Fleuren 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederike Jörg, Dr. contact
Frederike Jörg, Dr. principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KOPPeling in people with Children of Parents With a Mental Illness (COPMI), run by University Medical Center Groningen 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 2 inclusion and 1 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 Aug 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 Lisa Maeder, M.Sc. (+31686550763, l.maeder@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 NCT05829408, which also lists 5 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 Aug 2024.