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
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
-
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.