Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Ms Gretchen Bjornstad
ORCID ID
Contact details
University of Oxford
Department of Social Policy and Social Work
Barnett House
32 Wellington Square
Oxford
OX1 2ER
United Kingdom
+44 (0)1865 270342
gretchen.bjornstad@socres.ox.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00299442
Protocol/serial number
05/Q1606/57
Study information
Scientific title
Acronym
Study hypothesis
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.
Ethics approval
Approved by National Health Service (NHS) Oxfordshire Research Ethics Committee C, reference number 05/Q1606/57.
Study design
Randomised, controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Behavioural problems in children
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Child behaviour problems as measured by parent's report and teacher's report post-treatment and at six-month follow-up
Secondary outcome measures
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
Overall trial start date
01/04/2006
Overall trial end date
31/08/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
70 (100 subjects will be recruited to allow for dropout)
Participant exclusion criteria
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
Recruitment start date
01/04/2006
Recruitment end date
31/08/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Oxford
Oxford
OX1 2ER
United Kingdom
Sponsor information
Organisation
University of Oxford (UK)
Sponsor details
c/o Dr Paul Montgomery
Deparment of Social Policy and Social Work
Barnett House
32 Wellington Square
Oxford
OX1 2ER
United Kingdom
+44 (0)1865 280325
paul.montgomery@socres.ox.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Oxford Research Development Fund and Oxfordshire Health Services Research Committee (OHSRC) Grant
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Publication citations
-
Results
Montgomery P, Bjornstad G, Dennis J, Media-based behavioural treatments for behavioural problems in children., Cochrane Database Syst Rev, 2006, 1, CD002206, doi: 10.1002/14651858.CD002206.pub3.