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van CCT (UK)

van CCT (UK)

'You are okay'

- candidate number19657
- NTR NumberNTR4845
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-okt-2014
- Secondary IDs70-72900-98-13201 ZonMw
- Public Title'You are okay'
- Scientific Title'You are okay: An Intervention for Children with Mild Intellectual Disability of Parents with a Mental Illness (COPMI)'
- hypothesisCOPMI (Children of Parents with a Mental Illness) have an increased risk for developing problems themselves. A low IQ is an extra risk factor for developing psychosocial problems. By offering a support-group intervention for children with mild intellectual disability (ID) and a short online intervention for their parents, we expect an increase in risk factors and a decrease in protective factors. In children we expect an increase in feelings of competence and a decrease in emotional and behavioural problems . In parents we expect an increase in feelings of competence and involvement with their child. Hypothesis is that de combined program 'you are okay' for children and parents will be more effective on these goals than care as usual.
- Healt Condition(s) or Problem(s) studiedIntellectual disabillities, Mental disorders, Substance abuse, Parental psychosocial problems
- Inclusion criteria- Youngsters between ten and twenty years old with a mild intellectual disability.
- At least one of the parents has mental health problems or a substance use disorder. The parent recognizes these problems.
- When youngsters are in any kind of treatment facility or residental care, their lives should have reached some stability in order to be able to reflect on their parentís illness. Hence, we only include youngsters in this study who are at least one year in treatment .
- Exclusion criteria- Youngsters who have severe emotional or behavioral problems which impede participation in a group intervention.
- Presence of a crisis situation
- Risk for loyalty conflicts between children and parents (e.g. parent is aversive about the child discussing the parentís illness with others).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2014
- planned closingdate1-aug-2016
- Target number of participants80
- Interventions'You are okay':
An existing evidence-based support group-intervention for children of parents with a mental illness or substance use disorder was adapted to the needs of children with mild ID. In this support group intervention, children meet in ten sessions and a boostersession. In these sessions, children learn several skills to cope with difficult situations according their parent with problems. They provide each other with support and practice new skills through for example, role playing games. By practising these skills, we expect that their feelings of competence will increase. Each session has a different theme, such as basic emotions, coping with difficult situations and social skills.
Parrallel to the support-group intervention for the youngsters, their parents are offered a short online intervention of two sessions. This online intervention is also an adaptation of an intervention which is offered to parents of children without ID. In the two online sessions parents receive psycho-education, discuss their role as a parent and learn about the possible influence of their problems on their child. Parents are supported by completing the sessions if necessary.
- Primary outcomeFeelings of competence in children
Emotional and behavioural problems in children
- Secondary outcomeSocial support in children and parents
Feelings of parental competence
Involvement of parents with their child
Parenting behaviour
- Timepoints1. Baseline
2. 10 weeks
3. 3 months

- Childrenís feelings of competence (CBSA) (self worth and social acceptance)
- Childrenís COPMI specific feelings of competence (self-developed questionnaire)
- Childrenís emotional and behavioural problems (SDQ)
- Childrenís social support (NRI)
- Parentís Involvement with their child (question 1-10)
- Parenting behaviour (Parenting scale)
- Parentís feelings of parental competence (OO&O)
- Severity of the premental health problems parents (BSI)
- Well-being of parents (WHO-5)
- Social support parents (NRI, SSL)
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator Pluryn Research & Development
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development, Anthonia Wilhelmina Fonds
- Publications
- Brief summaryIn this randomized controlled trial the effectiveness will be studied of a support group-intervention for children with mild intellectual disabilities (ID) of parents with mental health problems in combination with an online intervention for parents. The intervention group will be compared to care as usual. Children in the experimental group receive ten weekly sessions and a booster session. Parallel to the child sessions, their parent will be offered two online individual sessions. Measurements take place before start, after ten weeks and after three months. We expect that children in the experimental group show an increase in feelings of competence and a decrease in behavioural and emotional problems. We also expect an increase in parental involvement with their childís treatment and feelings of parental competence. The aims of the intervention for children are to increase childrenís knowledge about the mental health problems of their parent, to increase childrenís knowledge about basic feelings and emotions, to increase childrenís social skills and coping skills and to increase childrenís awareness about their social network. The aims of the intervention for parents are to increase parents knowledge about possible influence of their problems on their child, to increase parents communication skills, to increase parents awareness about their social network and to increase parents awareness of positive parenting behaviour.
- Main changes (audit trail)
- RECORD9-okt-2014 - 5-nov-2014

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