Randomised controlled trial of cognitive behavioural treatment of obsessional compulsive disorder in children and adolescents.
| ISRCTN | ISRCTN54248464 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54248464 |
| Secondary identifying numbers | SPGS 808 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 08/01/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Tim Williams
Scientific
Scientific
3 Craven Road
Reading
RG1 5LF
United Kingdom
| Phone | +44 (0)118 9315800 |
|---|---|
| sxswiams@reading.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Obsessive compulsive disorder (OCD) |
| Intervention | 1. Cognitive behavioural treatment 2. Waitlist control |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 01/10/1999 |
| Completion date | 30/03/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 8 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 21 (added 08/01/10, see publication) |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/10/1999 |
| Date of final enrolment | 30/03/2002 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
3 Craven Road
Reading
RG1 5LF
United Kingdom
RG1 5LF
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive South East (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2010 | Yes | No |
