NCT00299442

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2007

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 6, 2006

Completed
1.3 years until next milestone

Study Start

First participant enrolled

July 1, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

March 12, 2009

Status Verified

November 1, 2008

Enrollment Period

1.6 years

First QC Date

March 3, 2006

Last Update Submit

March 10, 2009

Conditions

Behavioral Symptoms

Keywords

behaviorconductchildparentingself-helpmedia-based

Outcome Measures

Primary Outcomes (3)

  • Eyberg Child Behavior Inventory

    6 months

  • Sutter-Eyberg Student Behavior Inventory

    10 weeks

  • Parent Daily Report

    6 months

Secondary Outcomes (6)

  • Depression-Anxiety Stress Scale

    10 weeks

  • Parent Sense of Competence Scale

    10 weeks

  • Parenting Scale

    10 weeks

  • Dyadic Adjustment Scale

    10 weeks

  • Strengths and Difficulties Questionnaire

    10 weeks

  • +1 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Self-help Triple P Behavioural Family Intervention

Behavioral: Self-help Triple P Behavioural Family Intervention

2

NO INTERVENTION

Wait-list control

Interventions

Self-help Triple P Behavioural Family InterventionBEHAVIORAL

10-week self-help workbook and videos

Also known as: Triple P
1

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

West Berkshire PCT

Reading, Berkshire, RG1 7TD, United Kingdom

RECRUITING

Wycombe CAMHS

High Wycombe, Buckinghamshire, HP13 5BW, United Kingdom

RECRUITING

Sue Nicholls Centre

Aylesbury, Bucks, HP20 1EG, United Kingdom

RECRUITING

Related Publications (1)

  • 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.

    PMID: 16437442BACKGROUND

MeSH Terms

Conditions

Behavioral SymptomsBehavior

Interventions

(tris(diphenylphosphinomethyl)phenylborate)(p-tolylnitrido)iron(I)

Study Officials

  • Paul Montgomery, D. Phil.

    University of Oxford

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gretchen J. Bjornstad, M.Sc.

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 3, 2006

First Posted

March 6, 2006

Study Start

July 1, 2007

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

March 12, 2009

Record last verified: 2008-11

Locations

GB(3)