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ISRCTN
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ISRCTN12814243
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ClinicalTrials.gov identifier
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NCT00299442
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Public title
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Self-help parent-training for conduct problems in children
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Scientific title
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Acronym
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N/A
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Serial number at source
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05/Q1606/57
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Study hypothesis
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Children in the treatment group will show significantly fewer behavioural problems than children in the control group at post-treatment and six-month follow-up as measured by parent and teacher report.
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Lay summary
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Ethics approval
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Approved by National Health Service (NHS) Oxfordshire Research Ethics Committee C, reference number 05/Q1606/57.
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Study design
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Randomised, controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Behavioural problems in children
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Participants - inclusion criteria
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Families with children aged 2-5, on the waiting lists of child and adolescent mental health service clinics, and scores in the clinical range on the standardised measure of child behavioural problems. At least one parent in each family must be literate and a fluent English speaker to participate because the self-administered intervention will primarily consist of written instructions and information in English.
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Participants - exclusion criteria
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1. Clients whose children score below a clinical cut-off score on a standardised measure of child behaviour problems. This is to ensure that participants are appropriate for an intervention aiming to reduce behaviour problems.
2. Non-English speakers or those who are unable to read cannot be included because reading English is required to complete the self-administered intervention
3. Children or parents with severe disabilities and children with a developmental disorder (e.g. autism) will be excluded because the version of the parent-training programme that will be implemented is not designed for families with these types of problems
4. Children who live with a temporary carer will be excluded because the intervention is designed for full-time parents and follow-up will be after one year
5. Children or parents who are currently receiving treatment for psychological problems will be excluded because outcomes may be influenced by interventions not affiliated with this project
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Anticipated start date
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01/04/2006
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Anticipated end date
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31/08/2008
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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70 (100 subjects will be recruited to allow for dropout)
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Interventions
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Please note that, as of 18/03/2008, the anticipated end date was updated from 01/10/2007 to 31/08/2008.
This project will introduce a self-help parent-training programme for families on NHS waiting lists for child mental health services. It will examine whether access to treatment can be increased by providing an intervention that requires fewer resources and by releasing clinician time for more serious cases. This intervention will be tested in a randomised, controlled trial in which 35 subjects will receive treatment and 35 will not. All families will also complete questionnaires before and after treatment in order to measure changes in child behaviour, parenting, and parental-mental health. Cost-effectiveness of this programme will also be analysed. Intention-to-treat analyses will be conducted.
The control group will receive the self-help intervention after the intervention group completes their post-treatment outcome assessments. The treatment intervention is a self-help version of the Triple P parenting programme and will consist of six parent-training videos and a workbook that will be divided into 10 weeks of treatment, to be completed at home by the families. This intervention is based on social learning theory and provides information about preschoolers' development, promoting acceptable behaviour and responding to unacceptable behaviour in effective ways, promoting children's self-esteem and coping with stress. The control group will receive no treatment during this period.
Both groups will remain on the waiting list for treatment in a clinic and will commence that treatment if they still wish to do so when they reach the end of the waiting list, regardless of their position in the trial.
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Primary outcome measure(s)
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Child behaviour problems as measured by parent's report and teacher's report post-treatment and at six-month follow-up
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Secondary outcome measure(s)
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1. Utilisation of mental health services after treatment
2. Parental mental health
3. Parents' sense of competence in parenting
4. Parent's self-report of parenting practices
5. Families' satisfaction with treatment
6. Parent report of parental relationship quality
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Sources of funding
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University of Oxford Research Development Fund and Oxfordshire Health Services Research Committee (OHSRC) Grant
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Trial website
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http://www.apsoc.ox.ac.uk/EBIG.html
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Publications
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Results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=Abstract&list_uids=16437442&query_hl=1&itool=pubmed_docsum
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Contact name
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Ms
Gretchen
Bjornstad
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Address
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University of Oxford
Department of Social Policy and Social Work
Barnett House
32 Wellington Square
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City/town
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Oxford
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Zip/Postcode
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OX1 2ER
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Country
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United Kingdom
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Tel
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+44 (0)1865 270342
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Fax
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+44 (0)1865 270324
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Email
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gretchen.bjornstad@socres.ox.ac.uk
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Sponsor
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University of Oxford (UK)
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Address
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c/o Dr Paul Montgomery
Deparment of Social Policy and Social Work
Barnett House
32 Wellington Square
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City/town
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Oxford
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Zip/Postcode
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OX1 2ER
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Country
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United Kingdom
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Tel
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+44 (0)1865 280325
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Fax
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+44 (0)1865 270324
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Email
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paul.montgomery@socres.ox.ac.uk
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Date applied
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04/02/2005
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Last edited
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18/03/2008
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Date ISRCTN assigned
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26/06/2006
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