KOPPeling: Help From Your Own Circle

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Change in Quality of Life (QoL) of COPMI [Срок оценки: 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]

Вторичные конечные точки (6)

• Change in mental health of COPMI [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: At the end of the intervention (ten to twelve weeks after the start of the intervention)]

Критерии участия

Критерии включения

• 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

Критерии исключения

\- The family has no existing social network

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Нидерланды · 1 центр

• UMC Groningen — Groningen

Публикации

• 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

Идентификаторы

NCT: NCT05829408 · 10196

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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