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

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

      • Singapore, Singapore, 168937
        • Institute of Mental Health, Singapore

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
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

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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