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Self-Help Parent Training for Conduct Problems in Children

Primary Purpose

Behavioral Symptoms

Status
Unknown status
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Self-help Triple P Behavioural Family Intervention
Sponsored by
University of Oxford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Behavioral Symptoms focused on measuring behavior, conduct, child, parenting, self-help, media-based

Eligibility Criteria

2 Years - 5 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • West Berkshire PCTRecruiting
  • Wycombe CAMHSRecruiting
  • Sue Nicholls CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Self-help Triple P Behavioural Family Intervention

Wait-list control

Outcomes

Primary Outcome Measures

Eyberg Child Behavior Inventory
Sutter-Eyberg Student Behavior Inventory
Parent Daily Report

Secondary Outcome Measures

Depression-Anxiety Stress Scale
Parent Sense of Competence Scale
Parenting Scale
Dyadic Adjustment Scale
Strengths and Difficulties Questionnaire
Therapy Attitude Inventory

Full Information

First Posted
March 3, 2006
Last Updated
March 10, 2009
Sponsor
University of Oxford
Collaborators
Oxford University Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT00299442
Brief Title
Self-Help Parent Training for Conduct Problems in Children
Official Title
Can Self-Help Parent Training Reduce Conduct Problems in Children on NHS Waiting Lists for Child Mental Health Services?
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Unknown status
Study Start Date
July 2007 (undefined)
Primary Completion Date
February 2009 (Anticipated)
Study Completion Date
February 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Oxford
Collaborators
Oxford University Hospitals NHS Trust

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behavioral Symptoms
Keywords
behavior, conduct, child, parenting, self-help, media-based

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Self-help Triple P Behavioural Family Intervention
Arm Title
2
Arm Type
No Intervention
Arm Description
Wait-list control
Intervention Type
Behavioral
Intervention Name(s)
Self-help Triple P Behavioural Family Intervention
Other Intervention Name(s)
Triple P
Intervention Description
10-week self-help workbook and videos
Primary Outcome Measure Information:
Title
Eyberg Child Behavior Inventory
Time Frame
6 months
Title
Sutter-Eyberg Student Behavior Inventory
Time Frame
10 weeks
Title
Parent Daily Report
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Depression-Anxiety Stress Scale
Time Frame
10 weeks
Title
Parent Sense of Competence Scale
Time Frame
10 weeks
Title
Parenting Scale
Time Frame
10 weeks
Title
Dyadic Adjustment Scale
Time Frame
10 weeks
Title
Strengths and Difficulties Questionnaire
Time Frame
10 weeks
Title
Therapy Attitude Inventory
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gretchen J. Bjornstad, M.Sc.
Phone
+44(0)1865 270342
Email
gretchen.bjornstad@socres.ox.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Montgomery, D. Phil.
Organizational Affiliation
University of Oxford
Official's Role
Principal Investigator
Facility Information:
Facility Name
West Berkshire PCT
City
Reading
State/Province
Berkshire
ZIP/Postal Code
RG1 7TD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chris Hollingshead
First Name & Middle Initial & Last Name & Degree
Gretchen J Bjornstad, M.Sc.
Facility Name
Wycombe CAMHS
City
High Wycombe
State/Province
Buckinghamshire
ZIP/Postal Code
HP13 5BW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Wimshurst
First Name & Middle Initial & Last Name & Degree
Gretchen Bjornstad, M.Sc.
Facility Name
Sue Nicholls Centre
City
Aylesbury
State/Province
Bucks
ZIP/Postal Code
HP20 1EG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eleanor Rowsell, Ph.D.
First Name & Middle Initial & Last Name & Degree
Gretchen J Bjornstad, M.Sc.

12. IPD Sharing Statement

Citations:
PubMed Identifier
16437442
Citation
Montgomery P, Bjornstad G, Dennis J. Media-based behavioural treatments for behavioural problems in children. Cochrane Database Syst Rev. 2006 Jan 25;2006(1):CD002206. doi: 10.1002/14651858.CD002206.pub3.
Results Reference
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Self-Help Parent Training for Conduct Problems in Children

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