Self-Help Parent Training for Conduct Problems in Children

Behavioral Symptoms Clinical Trial

Official title:

Can Self−Help Parent Training Reduce Conduct Problems in Children on NHS Waiting Lists for Child Mental Health Services?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00299442
• Other study ID #: 05/Q1606/57
• Secondary ID: ISRCTN12814243
• Status: Recruiting
• Phase: Phase 3
• First received: March 3, 2006
• Last updated: March 10, 2009
• Start date: July 2007
• Est. completion date: February 2009

Study information

• Verified date: November 2008
• Source: University of Oxford
• Contact: Gretchen J. Bjornstad, M.Sc.
• Phone: +44(0)1865 270342
• Email: gretchen.bjornstad[@]socres.ox.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial Summary

This project will introduce a self-help parent training programme for families on National Health Service (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 immediately and 35 will receive treatment after waiting for 10 weeks. All families will also complete questionnaires before and after the 10 week study period 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 5 Years

Eligibility

Inclusion Criteria:

• Families on waiting lists and child and adolescent mental health services clinics with children aged 2-5.

• Scores in the clinical range on a standardised measure of child behaviour problems.

• At least one parent in each family must be literate, fluent English speakers to participate because the self-administered intervention will primarily consist of written instructions and information in English.

Exclusion Criteria:

• 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.

• Non-English speakers or those who are unable to read cannot be included because reading English is required to complete the self-administered intervention.

• 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.

• Children who live with a temporary caregiver will be excluded because the intervention is designed for full-time parents and follow-up will be after one year.

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Behavioral Symptoms

Intervention

Behavioral:
• Self-help Triple P Behavioural Family Intervention
10-week self-help workbook and videos

Locations

Country	Name	City	State
United Kingdom	Sue Nicholls Centre	Aylesbury	Bucks
United Kingdom	Wycombe CAMHS	High Wycombe	Buckinghamshire
United Kingdom	West Berkshire PCT	Reading	Berkshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	Oxford University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Montgomery P, Bjornstad G, Dennis J. Media-based behavioural treatments for behavioural problems in children. Cochrane Database Syst Rev. 2006 Jan 25;(1):CD002206. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eyberg Child Behavior Inventory		6 months	No
Primary	Sutter-Eyberg Student Behavior Inventory		10 weeks	No
Primary	Parent Daily Report		6 months	No
Secondary	Depression-Anxiety Stress Scale		10 weeks	No
Secondary	Parent Sense of Competence Scale		10 weeks	No
Secondary	Parenting Scale		10 weeks	No
Secondary	Dyadic Adjustment Scale		10 weeks	No
Secondary	Strengths and Difficulties Questionnaire		10 weeks	No
Secondary	Therapy Attitude Inventory		10 weeks	No