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Schema, Emotion and Behavior-Based Therapy for School Children (SEBASTIEN JR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of California, Los Angeles
Sponsor:
Information provided by (Responsible Party):
Jeffrey J. Wood, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT02010086
First received: December 9, 2013
Last updated: NA
Last verified: December 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Autism Spectrum Disorder
Behavioral: Individual Cognitive Behavioral Therapy
Behavioral: Standard Community Treatment

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: Cognitive Behavioral Therapy for Core Autism Symptoms in School-Age Children

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Playground Observation of Peer Engagement scale [ Time Frame: Post-Treatment (week 32) ] [ Designated as safety issue: No ]
    An independent evaluator-rated school playground observational measure of joint engagement, which is a valid measure of core autism symptoms with established treatment sensitivity


Estimated Enrollment: 44
Study Start Date: December 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Individual Cognitive Behavioral Therapy Behavioral: Individual Cognitive Behavioral Therapy
Therapists will work with families for 32 weekly sessions, each lasting 90 minutes, 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 provide a standard community therapy 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 for youngsters with ASD.

  Eligibility

Ages Eligible for Study:   6 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 6-9 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02010086

Contacts
Contact: Jeffrey J Wood, Ph.D. (310) 882-0537 jwood@gseis.ucla.edu
Contact: Kaycie Zielinski, MA (310) 882-0537 kzielinski@ucla.edu

Locations
United States, California
Jeffrey Wood Recruiting
Los Angeles, California, United States, 90024
Contact: Jeffrey J Wood, Ph.D.    310-882-0537    jwood@gseis.ucla.edu   
Contact: Kaycie Zielinski, MA    (310) 882-0537    kzielinski@ucla.edu   
Principal Investigator: Jeffrey J Wood, Ph.D.         
Sponsors and Collaborators
University of California, Los Angeles
  More Information

Additional Information:
No publications provided

Responsible Party: Jeffrey J. Wood, Associate Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02010086     History of Changes
Other Study ID Numbers: 12000556, Autism Speaks 7552
Study First Received: December 9, 2013
Last Updated: December 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Intervention
Autism
Treatment sensitivity
School aged
Cognitive behavioral therapy
Social Skills Intervention

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

ClinicalTrials.gov processed this record on November 25, 2014