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
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|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorder||Behavioral: Individual Cognitive Behavioral Therapy Behavioral: Standard Community Treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|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.
- 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
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|Ages Eligible for Study:||6 Years to 10 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
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
|United States, California|
|Los Angeles, California, United States, 90024|
|Responsible Party:||Jeffrey J. Wood, Associate Professor, University of California, Los Angeles|
|Other Study ID Numbers:||
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|
Cognitive behavioral therapy
Social Skills Intervention
Autism Spectrum Disorder
Child Development Disorders, Pervasive