- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01031511
Effect of Cognitive Behavioural Therapy (CBT) for Children With Autistic Spectrum Disorders
December 11, 2009 updated by: National Healthcare Group, Singapore
A Randomised Controlled Trial on the Effect of Cognitive-behavioural Therapy for High-functioning Children With Autistic Spectrum Disorder
Cognitive Behavioural Therapy is an effective intervention program for children with High-Functioning Autistic Spectrum Disorder to remediate anxiety issues.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
73
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Singapore, Singapore, 168937
- Institute of Mental Health, Singapore
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
9 years to 16 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Assessed to have Autistic Spectrum Disorder, Asperger Syndrome, Pervasive Developmental Disorder, Not Otherwise Specified by the DSM-IV criteria, based on clinical interview, Asperger Syndrome Diagnostic Scale (ASDS) or Autism Diagnostic Observation Schedule (ADOS)
- Child have a Verbal Comprehension Index of 80 and Perceptual Reasoning Index of 90 and above
- No change of medication dosage 1 month prior to the commencement of program for the child and through out the duration of the study
- Written parental consent and assent from children above 12 years old
Exclusion Criteria:
- Children with Verbal Comprehension Index of 80 and Perceptual Reasoning Index of 90 and below.
- Children who are undergoing other Cognitive Behavioural treatment program concurrently
- Those without parental consent will not be able to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
|
16 weekly sessions of 1.5 hrs in small groups of 3-4 children, conducted by 2 therapists
|
|
Experimental: Treatment Group - CBT
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16 weekly sessions of 1.5 hrs in small groups of 3-4 children conducted by 2 therapists
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Anxiety level of child
Time Frame: Pre Treatment, Post-treatment, 3 months follow-up, 6 months follow-up, One year follow-up
|
Pre Treatment, Post-treatment, 3 months follow-up, 6 months follow-up, One year follow-up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Parent Stress Level
Time Frame: Pre Treatment, Post-treatment, 3 months follow-up, 6 months follow-up, One year follow-up
|
Pre Treatment, Post-treatment, 3 months follow-up, 6 months follow-up, One year follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Min Sung, Institute of Mental Health, Singapore
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2005
Primary Completion (Anticipated)
January 1, 2010
Study Completion (Anticipated)
February 1, 2011
Study Registration Dates
First Submitted
December 11, 2009
First Submitted That Met QC Criteria
December 11, 2009
First Posted (Estimate)
December 14, 2009
Study Record Updates
Last Update Posted (Estimate)
December 14, 2009
Last Update Submitted That Met QC Criteria
December 11, 2009
Last Verified
February 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DSRB Ref Code: A/05/091
- NMRC/1002/2005 (Other Grant/Funding Number: National Medical Research Council (Singapore))
- 130/2005 (Other Identifier: Institute of Mental Health (Singapore) Clinical Research Committee)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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