Condition category
Mental and Behavioural Disorders
Date applied
11/03/2004
Date assigned
11/05/2004
Last edited
04/07/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Derek Bolton

ORCID ID

Contact details

Department of Psychology
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
United Kingdom
+44 (0)20 7848 5011
D.Bolton@iop.kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MREC 0312045

Study information

Scientific title

Acronym

Study hypothesis

The aims of the study are:
1. To determine the effectiveness of Cognitive Behaviour Therapy (CBT) for children and adolescents with Obsessive Compulsive Disorder (OCD) and the extent to which this can be sustained by a treatment with relatively low intensity of therapist contact
2. To produce a treatment practice manual suitable for dissemination
3. To identify patient characteristics that may be related to differential treatment
response
4. To determine whether treatment improves quality of life
5. To investigate service use associated with the two treatments

Ethics approval

No ethics information provided at time of registration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Obsessive Compulsive Disorder

Intervention

Participants will be randomly assigned to one of three conditions:
1. Standard CBT: comprising 12 sessions therapist contact and handouts explaining the features of OCD and its treatment. Both this and the brief CBT will be delivered over a three month period.
2. Brief CBT: comprising five sessions therapist contact and use of a detailed multi-section work-book intended to supplement the therapy sessions.
3. Waiting-list/delayed treatment, for three months. At the end of this period if the child still has diagnosable OCD they will be offered treatment in either of the first two conditions on a randomized basis. This group will act as the control group for the study.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Child Yale-Brown Obsessive Compulsive Scale (CY-BOCS) (Scahill et al. 1997).

Secondary outcome measures

1. Anxiety Disorders Interview Schedule for Children and Parents (ADIS-C/P, Silverman & Nelles, 1988)
2. Obsessive Compulsive Inventory (OCI) adapted for use with children (Foa et al. 1997)
3. Responsibility Attitude Scale (Salkovskis et al. 2000)
4. Child OCD Impact Scale (COIS) child and parent version (Piacentini et al. 2001)
5. Manchester Short Assessment of Quality of Life (MANSA) (Priebe et al. 1999)

Overall trial start date

01/10/2003

Overall trial end date

31/03/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 10 to 18
2. Diagnosis of OCD according to Diagnostic and Statistical Manual of Mental Disorders, Fourth edition (DSM-IV) criteria
3. If on medication, on a stable dosage for at least six weeks

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

110

Participant exclusion criteria

1. Immediate suicide risk
2. Intelligence Quotient (IQ) less than 70
3. Comorbid diagnosis of autism or marked autistic spectrum features, or psychosis, which commonly raise problems about differential diagnosis
4. Comorbid condition which has greater treatment priority (such as some cases of depression, or school-refusal)

Recruitment start date

01/10/2003

Recruitment end date

31/03/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Psychology
London
SE5 8AF
United Kingdom

Sponsor information

Organisation

King's College London (UK)

Sponsor details

Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
United Kingdom
G.Dale@iop.kcl.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

The Health Foundation (UK) (reference Number 1206/1782)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21644984

Publication citations

  1. Results

    Bolton D, Williams T, Perrin S, Atkinson L, Gallop C, Waite P, Salkovskis P, Randomized controlled trial of full and brief cognitive-behaviour therapy and wait-list for paediatric obsessive-compulsive disorder., J Child Psychol Psychiatry, 2011, 52, 12, 1269-1278, doi: 10.1111/j.1469-7610.2011.02419.x.

Additional files

Editorial Notes