Autism Spectrum Disorder Clinical Trial
Official title:
Efficacy of a Comprehensive School-based Intervention for High-functioning Children With Autism Spectrum Disorder
Verified date | November 2017 |
Source | Canisius College |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study was a 4-year efficacy trial (cluster randomized trial) of a comprehensive school-based intervention (CSBI) for high-functioning elementary students with autism spectrum disorder (HFASD). The sample included children, in grades 1-5 with HFASD enrolled in public schools. School buildings were randomly assigned to either receive the CSBI or serve as the control comparison (business-as-usual [BAU]). School staff in the CSBI schools administered social skills groups (60-90 minutes per week), facial-emotion recognition computer instruction (60 minutes per week), therapeutic activities (40-60 minutes per week), a behavioral reinforcement system (across the school day), and parent training (60-90 minutes per month) during the school year. Children with HFASD in the BAU schools received their typical educational program. Implementation fidelity was assessed by research assistants throughout the school year in the CSBI schools using standardized fidelity monitoring sheets. The fidelity monitoring sheets were also completed by research assistants during observations in the BAU schools in order to identify the possible presence of any of the treatment elements in the control (BAU) schools. Outcome measures were completed for both groups at baseline (6 weeks into the school year prior to the initiation of the intervention) and at the end of the school year following completion of the intervention. Primary outcome measures included a test of emotion recognition and parent-teacher ratings of ASD symptoms and secondary measures included parent-teacher ratings of social/social-communication skills, a test of academic achievement skills, and a direct behavioral measure of social interaction skills (child testing and behavioral observations were completed by evaluators blinded to treatment condition; parent-teacher raters were not blinded to treatment condition). For the primary measures/analyses, it was hypothesized that students with HFASD who complete the CSBI will demonstrate significantly greater emotion-recognition skills and receive significantly lower parent-teacher ratings of ASD symptoms compared to controls. For the secondary measures/analyses, it was hypothesized that students with HFASD who complete the CSBI will receive significantly higher parent-teacher ratings of social/social-communication skills, demonstrate significantly higher academic skills, and exhibit significantly higher rates of social interactions with peers compared to controls.
Status | Completed |
Enrollment | 103 |
Est. completion date | July 31, 2017 |
Est. primary completion date | July 31, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 12 Years |
Eligibility |
Inclusion Criteria: (1) WISC-IV short form IQ>70 (and VCI or PRI>80); (2) CASL expressive
or receptive language score >75; and (3) a score meeting ASD criteria on the ADI-R Exclusion Criteria: Evidence of psychosis |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Canisius College | U.S. Department of Education |
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McGinnis, E., & Goldstein, A. P. (1997). Skillstreaming the elementary school child: New strategies and perspectives for teaching prosocial skills, revised edition. Champaign, Il: Research Press.
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline Cambridge Mindreading Face-Voice Battery for Children (CAM-C) Scores at Follow-up | Total score used to assess emotion recognition skills; scores range from 0 to 90, with higher scores indicating better emotion recognition accuracy/skills | Baseline (immediately prior to treatment) and follow-up (immediately following treatment) | |
Primary | Change from Baseline Social Responsiveness Scale, 2nd Edition, School Age Form (SRS-2) Scores at Follow-up | SRS-2 total composite score normative mean = 50 and standard deviation = 10, with higher scores indicating more severe autism spectrum disorder symptoms/impairments | Baseline (immediately prior to treatment) and follow-up (immediately following treatment) | |
Secondary | Change from Baseline Adapted Skillstreaming Checklist (ASC) Scores at Follow-up | Total ASC score used to assess social/social-communication skills; scores range from 38 to 190, with higher scores indicating greater use of social/social-communication skills | Baseline (immediately prior to treatment) and follow-up (immediately following treatment) | |
Secondary | Change from Baseline Woodcock-Johnson III Tests of Achievement (WJ III ACH) Scores at Follow-up | Standard scores (mean = 100 and standard deviation = 15) used from the Letter Word Identification, Calculation, Spelling, Passage Comprehension, and Writing Samples subtests, with higher scores indicating better academic skills | Baseline (immediately prior to treatment) and follow-up (immediately following treatment) | |
Secondary | Change from Baseline Social Interaction Observation Scale (SIOS) Scores at Follow-up | Total SIOS score used to measure the frequency of social interactions during social activities, with higher total scores indicating more social interactions | Baseline (immediately prior to treatment) and follow-up (immediately following treatment) |
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