Overview

This trial is active, not recruiting.

Conditions autism spectrum disorder, anxiety
Treatments cognitive behavioural therapy, social recreational
Phase phase 0
Sponsor National Healthcare Group, Singapore
Collaborator Nayang Technological University, Singapore
Start date June 2005
End date January 2010
Trial size 73 participants
Trial identifier NCT01031511, 130/2005, DSRB Ref Code: A/05/091, NMRC/1002/2005

Summary

Cognitive Behavioural Therapy is an effective intervention program for children with High-Functioning Autistic Spectrum Disorder to remediate anxiety issues.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
cognitive behavioural therapy
16 weekly sessions of 1.5 hrs in small groups of 3-4 children conducted by 2 therapists
(No Intervention)
social recreational
16 weekly sessions of 1.5 hrs in small groups of 3-4 children, conducted by 2 therapists

Primary Outcomes

Measure
Anxiety level of child
time frame: Pre Treatment, Post-treatment, 3 months follow-up, 6 months follow-up, One year follow-up

Secondary Outcomes

Measure
Parent Stress Level
time frame: Pre Treatment, Post-treatment, 3 months follow-up, 6 months follow-up, One year follow-up

Eligibility Criteria

Male or female participants from 9 years up to 16 years old.

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

Additional Information

Official title A Randomised Controlled Trial on the Effect of Cognitive-behavioural Therapy for High-functioning Children With Autistic Spectrum Disorder
Principal investigator Min Sung
Trial information was received from ClinicalTrials.gov and was last updated in December 2009.
Information provided to ClinicalTrials.gov by National Healthcare Group, Singapore.