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

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Individual Cognitive Behavioral Therapy
Standard Community Treatment
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Intervention, Autism, Treatment sensitivity, School aged, Cognitive behavioral therapy, Social Skills Intervention

Eligibility Criteria

6 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Jeffrey Wood

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Individual Cognitive Behavioral Therapy

Standard Community Treatment

Arm Description

Outcomes

Primary Outcome Measures

Playground Observation of Peer Engagement scale
An independent evaluator-rated school playground observational measure of joint engagement, which is a valid measure of core autism symptoms with established treatment sensitivity

Secondary Outcome Measures

Full Information

First Posted
December 9, 2013
Last Updated
September 5, 2018
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT02010086
Brief Title
Schema, Emotion and Behavior-Based Therapy for School Children
Acronym
SEBASTIEN JR
Official Title
Cognitive Behavioral Therapy for Core Autism Symptoms in School-Age Children
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
December 2011 (Actual)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Intervention, Autism, Treatment sensitivity, School aged, Cognitive behavioral therapy, Social Skills Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Individual Cognitive Behavioral Therapy
Arm Type
Experimental
Arm Title
Standard Community Treatment
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Individual Cognitive Behavioral Therapy
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Standard Community Treatment
Intervention Description
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 Measure Information:
Title
Playground Observation of Peer Engagement scale
Description
An independent evaluator-rated school playground observational measure of joint engagement, which is a valid measure of core autism symptoms with established treatment sensitivity
Time Frame
Post-Treatment (week 32)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Jeffrey Wood
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34460285
Citation
Wood JJ, Kuhfeld M, Sturm A, Cai L, Wood KS, Cornejo Guevara MV, Galan CA, Johnson AR, Cho AC, Weisz JR. Personalized autism symptom assessment with the Youth Top Problems Scale: Observational and parent-report formats for clinical trials applications. Psychol Assess. 2022 Jan;34(1):43-57. doi: 10.1037/pas0001065. Epub 2021 Aug 30.
Results Reference
derived
PubMed Identifier
33705167
Citation
Wood JJ, Sze Wood K, Chuen Cho A, Rosenau KA, Cornejo Guevara M, Galan C, Bazzano A, Zeldin AS, Hellemann G. Modular cognitive behavioral therapy for autism-related symptoms in children: A randomized controlled trial. J Consult Clin Psychol. 2021 Feb;89(2):110-125. doi: 10.1037/ccp0000621.
Results Reference
derived

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Schema, Emotion and Behavior-Based Therapy for School Children

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