- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00299442
Self-Help Parent Training for Conduct Problems in Children
March 10, 2009 updated by: University of Oxford
Can Self-Help Parent Training Reduce Conduct Problems in Children on NHS Waiting Lists for Child Mental Health Services?
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
70
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Berkshire
-
Reading, Berkshire, United Kingdom, RG1 7TD
- Recruiting
- West Berkshire PCT
-
Contact:
- Chris Hollingshead
-
Principal Investigator:
- Gretchen J Bjornstad, M.Sc.
-
-
Buckinghamshire
-
High Wycombe, Buckinghamshire, United Kingdom, HP13 5BW
- Recruiting
- Wycombe CAMHS
-
Contact:
- Susan Wimshurst
-
Principal Investigator:
- Gretchen Bjornstad, M.Sc.
-
-
Bucks
-
Aylesbury, Bucks, United Kingdom, HP20 1EG
- Recruiting
- Sue Nicholls Centre
-
Principal Investigator:
- Gretchen J Bjornstad, M.Sc.
-
Contact:
- Eleanor Rowsell, Ph.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 5 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: 1
Self-help Triple P Behavioural Family Intervention
|
10-week self-help workbook and videos
Other Names:
|
|
NO_INTERVENTION: 2
Wait-list control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Eyberg Child Behavior Inventory
Time Frame: 6 months
|
6 months
|
|
Sutter-Eyberg Student Behavior Inventory
Time Frame: 10 weeks
|
10 weeks
|
|
Parent Daily Report
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Depression-Anxiety Stress Scale
Time Frame: 10 weeks
|
10 weeks
|
|
Parent Sense of Competence Scale
Time Frame: 10 weeks
|
10 weeks
|
|
Parenting Scale
Time Frame: 10 weeks
|
10 weeks
|
|
Dyadic Adjustment Scale
Time Frame: 10 weeks
|
10 weeks
|
|
Strengths and Difficulties Questionnaire
Time Frame: 10 weeks
|
10 weeks
|
|
Therapy Attitude Inventory
Time Frame: 10 weeks
|
10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Paul Montgomery, D. Phil., University of Oxford
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2007
Primary Completion (ANTICIPATED)
February 1, 2009
Study Completion (ANTICIPATED)
February 1, 2009
Study Registration Dates
First Submitted
March 3, 2006
First Submitted That Met QC Criteria
March 3, 2006
First Posted (ESTIMATE)
March 6, 2006
Study Record Updates
Last Update Posted (ESTIMATE)
March 12, 2009
Last Update Submitted That Met QC Criteria
March 10, 2009
Last Verified
November 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05/Q1606/57
- ISRCTN12814243
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.