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

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ClinicalTrials.gov Identifier: NCT02010086
Recruitment Status : Completed
First Posted : December 12, 2013
Last Update Posted : September 7, 2018
Information provided by (Responsible Party):
Jeffrey J. Wood, University of California, Los Angeles

Brief Summary:
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 or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: Individual Cognitive Behavioral Therapy Behavioral: Standard Community Treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Behavioral Therapy for Core Autism Symptoms in School-Age Children
Actual Study Start Date : December 2011
Actual Primary Completion Date : November 2015
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

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, 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.

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02010086

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United States, California
Jeffrey Wood
Los Angeles, California, United States, 90024
Sponsors and Collaborators
University of California, Los Angeles
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jeffrey J. Wood, Associate Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02010086    
Other Study ID Numbers: 12000556
Autism Speaks 7552 ( Other Grant/Funding Number: Autism Speaks 7552 )
First Posted: December 12, 2013    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Keywords provided by Jeffrey J. Wood, University of California, Los Angeles:
Treatment sensitivity
School aged
Cognitive behavioral therapy
Social Skills Intervention
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders