Effect of Cognitive Behavioural Therapy (CBT) for Childre... | NCT01031511

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

NCT01031511

Sponsor

National Healthcare Group, Singapore

Status

Unknown status

Last Update Posted

Dec 14, 2009Estimated

Enrollment

73Actual

Phase

Early Phase 1

Conditions

Autism Spectrum Disorder
Anxiety

Interventions

Cognitive Behavioural Therapy
Social Recreational

Countries

Singapore

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NMRC/1002/2005	Other Grant/Funding Number	National Medical Research Council (Singapore)
130/2005	Other Identifier	Institute of Mental Health (Singapore) Clinical Research Committee

Status Module

Record Verification Date

Feb 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2005

Primary Completion Date

Jan 2010Estimated

Completion Date

Feb 2011Estimated

First Submitted Date

Dec 11, 2009

First Submission Date that Met QC Criteria

Dec 11, 2009

First Posted Date

Dec 14, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 11, 2009

Last Update Posted Date

Dec 14, 2009Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

National Healthcare Group, SingaporeOTHER_GOV

Collaborators

Name	Class
Nanyang Technological University	OTHER
Autism Resource Centre, Singapore	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

73Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment Group - CBT	Experimental		Behavioral: Cognitive Behavioural Therapy
Control Group	No Intervention		Other: Social Recreational

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cognitive Behavioural Therapy	Behavioral	16 weekly sessions of 1.5 hrs in small groups of 3-4 children conducted by 2 therapists	Treatment Group - CBT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Anxiety level of child		Pre Treatment, Post-treatment, 3 months follow-up, 6 months follow-up, One year follow-up

Secondary Outcomes

Measure	Description	Time Frame
Parent Stress Level		Pre Treatment, Post-treatment, 3 months follow-up, 6 months follow-up, One year follow-up

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

9 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Min Sung	Institute of Mental Health, Singapore	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Mental Health, Singapore		Singapore		168937	Singapore

Type	Date	Date Unknown
Release	Oct 30, 2013
Reset	Dec 19, 2013
Release	Dec 23, 2013
Reset	Feb 8, 2014

Submission Tracking

Estimated Results First Submitted Date

Oct 30, 2013

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Oct 30, 2013			Dec 19, 2013
Dec 23, 2013

Condition Browse Module

MeSH Terms

ID	Term
D000067877	Autism Spectrum Disorder
D001008	Anxiety Disorders

Ancestor Terms

ID	Term
D002659	Child Development Disorders, Pervasive
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015928	Cognitive Behavioral Therapy

Ancestor Terms

ID	Term
D001521	Behavior Therapy
D011613	Psychotherapy
D004191	Behavioral Disciplines and Activities

Browse Leaves

Not provided

Browse Branches

Not provided