Self-help parent-training for conduct problems in children

ISRCTN	ISRCTN12814243
DOI	https://doi.org/10.1186/ISRCTN12814243
ClinicalTrials.gov number	NCT00299442
Secondary identifying numbers	05/Q1606/57

Submission date: 04/02/2005
Registration date: 26/06/2006
Last edited: 18/03/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Ms Gretchen Bjornstad
Scientific

University of Oxford
Department of Social Policy and Social Work
Barnett House
32 Wellington Square
Oxford
OX1 2ER
United Kingdom

Phone	+44 (0)1865 270342
Email	gretchen.bjornstad@socres.ox.ac.uk

Study information

Study design	Randomised, controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	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(s)	Approved by National Health Service (NHS) Oxfordshire Research Ethics Committee C, reference number 05/Q1606/57.
Health condition(s) or problem(s) studied	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
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 study start date	01/04/2006
Completion date	31/08/2008

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	2 Years
Upper age limit	5 Years
Sex	Both
Target number of participants	70 (100 subjects will be recruited to allow for dropout)
Key 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.
Key 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
Date of first enrolment	01/04/2006
Date of final enrolment	31/08/2008

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Oxford

Oxford
OX1 2ER
United Kingdom

Sponsor information

University of Oxford (UK)
University/education

c/o Dr Paul Montgomery
Deparment of Social Policy and Social Work
Barnett House
32 Wellington Square
Oxford
OX1 2ER
England
United Kingdom

Phone	+44 (0)1865 280325
Email	paul.montgomery@socres.ox.ac.uk
"ROR"	https://ror.org/052gg0110

Funders

Funder type

University/education

University of Oxford Research Development Fund and Oxfordshire Health Services Research Committee (OHSRC) Grant

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results:	25/01/2006		Yes	No