NCT01031511

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
73

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jun 2005

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

December 11, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 14, 2009

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

December 14, 2009

Status Verified

February 1, 2009

Enrollment Period

4.6 years

First QC Date

December 11, 2009

Last Update Submit

December 11, 2009

Conditions

Keywords

High-Functioning Autistic Spectrum DisorderAnxietyCognitive Behavioural TherapySocial RecreationalParent Stress

Outcome Measures

Primary Outcomes (1)

  • Anxiety level of child

    Pre Treatment, Post-treatment, 3 months follow-up, 6 months follow-up, One year follow-up

Secondary Outcomes (1)

  • Parent Stress Level

    Pre Treatment, Post-treatment, 3 months follow-up, 6 months follow-up, One year follow-up

Study Arms (2)

Treatment Group - CBT

EXPERIMENTAL
Behavioral: Cognitive Behavioural Therapy

Control Group

NO INTERVENTION
Other: Social Recreational

Interventions

16 weekly sessions of 1.5 hrs in small groups of 3-4 children conducted by 2 therapists

Treatment Group - CBT

16 weekly sessions of 1.5 hrs in small groups of 3-4 children, conducted by 2 therapists

Control Group

Eligibility Criteria

Age9 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Mental Health, Singapore

Singapore, 168937, Singapore

Location

MeSH Terms

Conditions

Autism Spectrum DisorderAnxiety Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Min Sung

    Institute of Mental Health, Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 11, 2009

First Posted

December 14, 2009

Study Start

June 1, 2005

Primary Completion

January 1, 2010

Study Completion

February 1, 2011

Last Updated

December 14, 2009

Record last verified: 2009-02

Locations