Condition category
Mental and Behavioural Disorders
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
08/01/2010
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

Dr Tim Williams

ORCID ID

Contact details

3 Craven Road
Reading
RG1 5LF
United Kingdom
+44 (0)118 9315800
sxswiams@reading.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SPGS 808

Study information

Scientific title

Acronym

Study hypothesis

To evaluate the efficacy of cognitive behavioural treatment for children and adolescents with obsessive compulsive disorder. OCD is a severely handicapping chronic relapsing psychological disorder with affects 0.5% to 2% of the population. 50% of adults with OCD develop the condition in adolescence, and 50% of the children with OCD continue to be disabled by it in adulthood. Although cognitive behavioural treatment (CBT) is the first choice treatment in childhood according to recent consensus guidelines, there has only been one RCT in adolescents and children. That study suffers from difficulties of interpretation and used a less powerful form of CBT than the best currently used with adults. RCTs in adulthood have found that 70& of patients with OCD benefit from CBT, and remain well following the end of treatment.
Research Objectives: To carry out a trial of a manulised cognitive behavioural treatment for obsessional compulsive disorder in children and adolescents, in order to ensure that it is effective in reducing the level of symptoms. To investigate the extent of the improvements in functioning resulting from the treatment method and compare them with the effects of time spent waiting for treatment.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Obsessive compulsive disorder (OCD)

Intervention

1. Cognitive behavioural treatment
2. Waitlist control

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The clinical status of the children and adolescents will be the main focus of the trial. The following tools will be used:
1. KIDDIE-SADS or equivalent semi-structured interview used to assess Mental state of the children
2. YBOCS (child version) used to measure obsessional compulsive symptoms by interview
3. Obsessive compulsive Inventory (OCI) - self-report measure of OCD
4. Responsibility Interpretation Questionnaire (RIQ) - self-report to measure cognitions specific to the treatment methods
5. Children's Depression Inventory (CDI)
6. Multidimensional Anxiety Scale for children (MASC) - self report
7. National Institute of Mental Health (NIMH) global obsessive compulsive scale

Following the example of most other studies in this field the YBOCS total score is considered to be the main focus of analysis.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/10/1999

Overall trial end date

30/03/2002

Reason abandoned

Eligibility

Participant inclusion criteria

Children and adolescents aged between 8 years and 18 years of age in full time education with obsessional compulsive disorder defined by research diagnostic criteria and whose medication has remained stable for 12 weeks prior to entry to trial.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

21 (added 08/01/10, see publication)

Participant exclusion criteria

Children with severe learning disabilities or severe language difficulties - because the treatment requires the use of verbal reasoning skills at the eight year plus level

Recruitment start date

01/10/1999

Recruitment end date

30/03/2002

Locations

Countries of recruitment

United Kingdom

Trial participating centre

3 Craven Road
Reading
RG1 5LF
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive South East (UK)

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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19921305

Publication citations

  1. Results

    Williams TI, Salkovskis PM, Forrester L, Turner S, White H, Allsopp MA, A randomised controlled trial of cognitive behavioural treatment for obsessive compulsive disorder in children and adolescents., Eur Child Adolesc Psychiatry, 2010, 19, 5, 449-456, doi: 10.1007/s00787-009-0077-9.

Additional files

Editorial Notes