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

Anxiety Clinical Trial

Official title:

A Randomised Controlled Trial on the Effect of Cognitive-behavioural Therapy for High-functioning Children With Autistic Spectrum Disorder

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01031511
• Other study ID #: DSRB Ref Code: A/05/091
• Secondary ID: NMRC/1002/200513
• Status: Unknown status
• Phase: Early Phase 1
• First received: December 11, 2009
• Last updated: December 11, 2009
• Start date: June 2005
• Est. completion date: February 2011

Study information

• Verified date: February 2009
• Source: National Healthcare Group, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 73
• Est. completion date: February 2011
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive
• Disease

Intervention

Behavioral:
• Cognitive Behavioural Therapy
16 weekly sessions of 1.5 hrs in small groups of 3-4 children conducted by 2 therapists

Other:
• Social Recreational
16 weekly sessions of 1.5 hrs in small groups of 3-4 children, conducted by 2 therapists

Locations

Country	Name	City	State
Singapore	Institute of Mental Health, Singapore	Singapore

Sponsors (3)

Lead Sponsor	Collaborator
National Healthcare Group, Singapore	Autism Resource Centre, Singapore, Nanyang Technological University

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety level of child		Pre Treatment, Post-treatment, 3 months follow-up, 6 months follow-up, One year follow-up
Secondary	Parent Stress Level		Pre Treatment, Post-treatment, 3 months follow-up, 6 months follow-up, One year follow-up