Condition category
Mental and Behavioural Disorders
Date applied
04/02/2005
Date assigned
26/06/2006
Last edited
18/03/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.apsoc.ox.ac.uk/EBIG.html

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 measures

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

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

Results - basic reporting

Publication summary

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

Publication citations

  1. 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.

Additional files

Editorial Notes