Schema, Emotion, and Behavior Therapy for Children (SEBASTIEN)

September 5, 2018 updated by: Jeffrey J. Wood, University of California, Los Angeles

Treatment of Autism Symptoms in Children (TASC): Initial RCT With Active Control

The study is a randomized controlled trial to examine the efficacy of individual cognitive behavioral therapy (CBT) relative to a standard community treatment, in youngsters with autism spectrum disorder (ASD). The individual CBT program has been tailored over the last five years to the clinical needs of high-functioning youth with ASD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Autism spectrum disorder (ASD) is among the most common childhood developmental disorders. A key goal in the field is the discovery of methods that reduce core autism symptoms. Core autism symptoms include social-cognitive impairments, pragmatic language deficits, and repetitive and rigid behaviors. The core symptoms tend to be stable and resistant to intervention. Most treatments involve group-based social skills training (SST), with limited effects. No treatment for core autism symptoms in school-aged children with ASD meets American Psychological Association guidelines for possible efficacy. Cognitive behavioral therapy (CBT) offers a novel approach for addressing core autism symptoms in higher functioning school-age youngsters. Initial results suggest that individual CBT may also be promising for reducing core autism symptoms (Wood et al., 2009b; Drahota, Wood et al., 2011). The treatment is based on a contemporary model of memory retrieval competition, employing strategies for enhancing the retention of adaptive conceptual and behavioral responses and the suppression of idiosyncratic beliefs and behaviors in daily social contexts, emphasizing the use of deep semantic processing to enhance memory retrieval. We are proposing a randomized controlled trial to examine the efficacy of individual CBT relative to a standard community treatment in youngsters with ASD.

Study Type

Interventional

Enrollment

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90024
        • Jeffrey Wood

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Meets research criteria for a diagnosis of autism, based on child scores on the ADI-R and ADOS tests.
  • If taking medication, have maintained a stable dose for 1 month prior to baseline assessment.
  • Between the ages of 9-13 years.
  • The child's teacher consents to participate in the study to play a modest role in helping implement the intervention and facilitate the school observation assessment.

Exclusion Criteria:

  • IQ less than 85.
  • The child starts taking new medication(s) or current medication dose changes either (a) less than 1 month prior to the diagnostic evaluation, or (b) during the study period.
  • The child is participating in an intensive early intervention program for autism such as applied behavior analysis or floortime.
  • For any reason the child or parents appear unable to participate in the treatment program.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Individual Cognitive Behavioral Therapy
Behavioral: Individual Cognitive Behavioral Therapy
Therapists will work with families for 32 weekly sessions, each lasting 90 minutes (45 minutes with the child and 45 minutes with the family/parents), implementing the CBT manual for children with ASD (Wood et al., 2007).
Active Comparator: Standard Community Treatment
Behavioral: Standard Community Treatment
In this condition, the child meets with a therapist for 32 weekly sessions, each 90 minutes. Therapists use an established manual to administer a standard community treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Playground Observation of Peer Engagement scale
Time Frame: Post-Treatment (week 32)
An independent evaluator-rated school playground observational measure of joint engagement, which is a valid measure of core autism symptoms with established treatment sensitivity
Post-Treatment (week 32)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

National Institute of Mental Health (NIMH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2012

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

March 23, 2012

First Submitted That Met QC Criteria

February 1, 2013

First Posted (Estimate)

February 5, 2013

Study Record Updates

Last Update Posted (Actual)

September 7, 2018

Last Update Submitted That Met QC Criteria

September 5, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-002061
  • 1R01MH094391-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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