Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ISRCTN |
Last refreshed on:
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22 October 2018 |
Main ID: |
ISRCTN48032451 |
Date of registration:
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18/01/2012 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Effectiveness of preventive support groups for children (aged 8-12) of mentally ill or addicted parents
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Scientific title:
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A randomized controlled trial of a preventive support group intervention aimed at preventing problem development in children of parents with mental disorder or substance use disorder |
Date of first enrolment:
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02/10/2007 |
Target sample size:
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228 |
Recruitment status: |
Completed |
URL:
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http://isrctn.com/ISRCTN48032451 |
Study type:
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Interventional |
Study design:
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Interventional multicentre randomized non blinded trial (Quality of life)
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Phase:
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Not Applicable
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Floor
van Santvoort |
Address:
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Radboud University
Department of Clinical Psychology
PO Box 9104
6500 HE
Nijmegen
Netherlands |
Telephone:
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+31 2436 12748 |
Email:
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f.vansantvoort@psych.ru.nl |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Children have at least one parent meeting the DSM-IV diagnostic criteria on Axis I or Axis II or the ICD-10 criteria for a mental disorder or substance use disorder
Exclusion criteria: 1. Children with a current psychiatric diagnosis 2. Children who received psychological treatment during the last year 3. Children who had already participated in a support group
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Mental health problems in children at risk Mental and Behavioural Disorders Behavioural and emotional disorders with onset usually occurring in childhood and adolescence
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Intervention(s)
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Intervention (support groups) The support groups comprise eight weekly sessions (1.5 hours) and a booster session after 2-3 months for children, one parent session, and a finishing family talk. All sessions are supervised by two trainers: a (child) mental health and a prevention expert. Each session starts with an evaluation of the last week and a group discussion and is closed with a homework assignment. Other techniques that are used include role plays, games, psycho-education, and discussions about several topics introduced through creative activities or multimedia. Leisure activities are also an important part as for many children moments to be a child without worries are scarce. Detailed instructions and contents of all the sessions are described in a standardized manual. The theory and practice based manual was developed in 2001 by a collaboration between local prevention experts and the Dutch National Institute for Mental Health and Addiction (Trimbos Institut), and is now used by all Dutch mental health centers.
Control (Six months waiting list with three leisure activities [parallel to the eight support group sessions]) Since the support groups are already offered for many years, it would have been unethical to deprive half of the children of the intervention. Hence, the control group participants received the support group intervention after six months when their participation in the study was finished. Moreover, while they were on the waiting list, these control group participants were offered three group-based leisure activities in order to reduce drop-out. The activities were organized by the mental health centers and were guided by one or two mental health or prevention experts or students. All activity sessions constituted of a group activity part, such as a game or a quest, and an individual activity part, like painting or baking cookies. Children were not stimulated to discuss their home situation. However, when a child started to talk about his/he
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Primary Outcome(s)
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1. Emotional and behavioral problems Measured with the Strengths and Difficulties Questionnaire, filled out by the parent (SDQ) (total problem scale) (0 = no problems, 40 = high problems, 14= Dutch clinical cut-off score) at baseline, after three months, and six months. 2. Child's negative cognitions measured with four self-developed questions regarding experiences of guilt, shame, and loneliness regarding the parental illness (mean score, justified with factor-analysis), filled out by the child (1 = low negative cognitions, 5 = high negative cognitions) at baseline, after three months, and six months. 3. Child's perceived social support Measured with three self-developed questions about the number of people with whom the children: communicate about their own problems, communicate about their ill parent, and undertake leisure activities, filled out by the child (mean score, justified with factor-analysis) (0 = low social support, 14 = high social support) at baseline, after three months, and six months. 4. Child's perceived competence Measured with two subscales of the Dutch version of the Self-Perception Profile for Children (SPPC): social acceptance and global self-worth (both scales: 6 = low perceived competence, 24 = high perceived competence) at baseline, after three months, and six months. 5. Parent-child interaction Measured with the Dutch Parent Child Interaction Questionnaire (OKIV), filled out by the child (total score) (25 = low quality of parent child interaction, 125 = high quality of parent child interaction) at baseline, after three months, and six months.
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Secondary Outcome(s)
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No secondary outcome measures
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Source(s) of Monetary Support
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Dutch Organization for Health Research and Development (ZonMw) ref: 62300034
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Ethics review
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Status:
Approval date:
Contact:
Dutch Medical Ethics Committee for Mental Health Centers (METiGG), 12 September 2007 ref: 7.106
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Results
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Results available:
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Yes |
Date Posted:
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Date Completed:
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14/06/2010 |
URL:
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