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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by National Healthcare Group, Singapore.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Nayang Technological University, Singapore
Autism Resource Centre, Singapore
Information provided by:
National Healthcare Group, Singapore
ClinicalTrials.gov Identifier:
NCT01031511
First received: December 11, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

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


Condition Intervention Phase
Autism Spectrum Disorder
Anxiety
 Behavioral: Cognitive Behavioural Therapy
Other: Social Recreational
 Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial on the Effect of Cognitive-behavioural Therapy for High-functioning Children With Autistic Spectrum Disorder

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Autism
U.S. FDA Resources

Further study details as provided by National Healthcare Group, Singapore:

Primary Outcome Measures:
  • Anxiety level of child [ Time Frame: Pre Treatment, Post-treatment, 3 months follow-up, 6 months follow-up, One year follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Parent Stress Level [ Time Frame: Pre Treatment, Post-treatment, 3 months follow-up, 6 months follow-up, One year follow-up ] [ Designated as safety issue: No ]

Enrollment: 73
Study Start Date: June 2005
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Group - CBT Behavioral: Cognitive Behavioural Therapy
16 weekly sessions of 1.5 hrs in small groups of 3-4 children conducted by 2 therapists
No Intervention: Control Group Other: Social Recreational
16 weekly sessions of 1.5 hrs in small groups of 3-4 children, conducted by 2 therapists

  Eligibility

Ages Eligible for Study:   9 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01031511

Locations
Singapore
Institute of Mental Health, Singapore
Singapore, Singapore, 168937
Sponsors and Collaborators
National Healthcare Group, Singapore
Nayang Technological University, Singapore
Autism Resource Centre, Singapore
Investigators
Principal Investigator: Min Sung Institute of Mental Health, Singapore
  More Information

No publications provided

Responsible Party: Min, Sung / Dr., Institute of Mental Health
ClinicalTrials.gov Identifier: NCT01031511     History of Changes
Other Study ID Numbers: DSRB Ref Code: A/05/091, NMRC/1002/2005, 130/2005
Study First Received: December 11, 2009
Last Updated: December 11, 2009
Health Authority: Singapore: Domain Specific Review Boards

Keywords provided by National Healthcare Group, Singapore:
High-Functioning Autistic Spectrum Disorder
Anxiety
Cognitive Behavioural Therapy
Social Recreational
Parent Stress

Additional relevant MeSH terms:
Anxiety Disorders
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders
Mental Disorders Diagnosed in Childhood

ClinicalTrials.gov processed this record on May 16, 2013