search
Back to results

Effect of Cognitive Behavioural Therapy (CBT) for Children With Autistic Spectrum Disorders

Primary Purpose

Autism Spectrum Disorder, Anxiety

Status
Unknown status
Phase
Early Phase 1
Locations
Singapore
Study Type
Interventional
Intervention
Cognitive Behavioural Therapy
Social Recreational
Sponsored by
National Healthcare Group, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring High-Functioning Autistic Spectrum Disorder, Anxiety, Cognitive Behavioural Therapy, Social Recreational, Parent Stress

Eligibility Criteria

9 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Mental Health, Singapore

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment Group - CBT

Control Group

Arm Description

Outcomes

Primary Outcome Measures

Anxiety level of child

Secondary Outcome Measures

Parent Stress Level

Full Information

First Posted
December 11, 2009
Last Updated
December 11, 2009
Sponsor
National Healthcare Group, Singapore
Collaborators
Nanyang Technological University, Autism Resource Centre, Singapore
search

1. Study Identification

Unique Protocol Identification Number
NCT01031511
Brief Title
Effect of Cognitive Behavioural Therapy (CBT) for Children With Autistic Spectrum Disorders
Official Title
A Randomised Controlled Trial on the Effect of Cognitive-behavioural Therapy for High-functioning Children With Autistic Spectrum Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Unknown status
Study Start Date
June 2005 (undefined)
Primary Completion Date
January 2010 (Anticipated)
Study Completion Date
February 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
National Healthcare Group, Singapore
Collaborators
Nanyang Technological University, Autism Resource Centre, Singapore

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Anxiety
Keywords
High-Functioning Autistic Spectrum Disorder, Anxiety, Cognitive Behavioural Therapy, Social Recreational, Parent Stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group - CBT
Arm Type
Experimental
Arm Title
Control Group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioural Therapy
Intervention Description
16 weekly sessions of 1.5 hrs in small groups of 3-4 children conducted by 2 therapists
Intervention Type
Other
Intervention Name(s)
Social Recreational
Intervention Description
16 weekly sessions of 1.5 hrs in small groups of 3-4 children, conducted by 2 therapists
Primary Outcome Measure Information:
Title
Anxiety level of child
Time Frame
Pre Treatment, Post-treatment, 3 months follow-up, 6 months follow-up, One year follow-up
Secondary Outcome Measure Information:
Title
Parent Stress Level
Time Frame
Pre Treatment, Post-treatment, 3 months follow-up, 6 months follow-up, One year follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Sung
Organizational Affiliation
Institute of Mental Health, Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Mental Health, Singapore
City
Singapore
ZIP/Postal Code
168937
Country
Singapore

12. IPD Sharing Statement

Learn more about this trial

Effect of Cognitive Behavioural Therapy (CBT) for Children With Autistic Spectrum Disorders

We'll reach out to this number within 24 hrs