Efficacy of a Comprehensive School-based Intervention for High-functioning Children With Autism Spectrum Disorder

NCT03338530 | Completed

• 1 other identifier: 2012-13#142RENEWAL-Ammend
• Study Type: interventional
• Target: 103
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Autism Spectrum Disorder

Keywords

Psychosocial treatment; School intervention; Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (3)

• Change from Baseline Adapted Skillstreaming Checklist (ASC) Scores at Follow-up

  Baseline (immediately prior to treatment) and follow-up (immediately following treatment)

• Change from Baseline Woodcock-Johnson III Tests of Achievement (WJ III ACH) Scores at Follow-up

  Baseline (immediately prior to treatment) and follow-up (immediately following treatment)

• Change from Baseline Social Interaction Observation Scale (SIOS) Scores at Follow-up

  Baseline (immediately prior to treatment) and follow-up (immediately following treatment)

Study Arms (2)

Comprehensive School-Based Intervention

EXPERIMENTAL

Children with HFASD assigned to the CSBI received social skills groups, computer instruction in emotion recognition, therapeutic activities, and a behavioral reinforcement system (individual daily note) during the school year and their parents participated in monthly parent training. School staff received training prior to the school year and demonstrated fidelity with the protocol. Fidelity was also monitored during the school year by research assistants.

Behavioral: Comprehensive School-Based Intervention

Business-As-Usual (BAU) Control

NO INTERVENTION

Children with HFASD in the BAU schools received their typical special education programming as legally-mandated. The programming received by each was carefully monitored per the following: 1) Each student's IEP was reviewed to document the legally mandated services received; 2) For those receiving counseling or speech-language services, the related-service provider completed a survey indicating specific treatment targets and the protocol for service provision; 3) Parents completed a monthly survey of any external therapeutic programming their child may have received; and 4) Fidelity measures designed for the intervention group (with sequencing requirements removed) were completed for the control condition during two 60-minute classroom observations per week by research assistants.

Interventions

Comprehensive School-Based Intervention BEHAVIORAL

School staff administered the 5 components during the school year. Social Skills Groups were conducted 2-3x/wk. for a total of 60-90 min./wk.; each group contained 3-6 students with social impairments. The Individual Daily Note was administered across the school day to reinforce new skills and reduce problem symptoms. Students' performance on targets was linked to home rewards. Mind Reading computer instruction targeting emotion recognition skills was conducted 3x/wk. for a total of 60 min./wk. Therapeutic Activities were conducted 2x/wk. for a total of 40-60 min./wk.; these cooperative activities were designed to practice targeted skills. Parent Training was conducted 1x/month for 60-90 min./session in order to increase home-school communication and integrate the CSBI across settings.

Comprehensive School-Based Intervention

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

Sponsors & Collaborators

• Canisius College: lead
• U.S. Department of Education: collaborator

Related Publications (15)

• Goldstein, A. P., McGinnis, E., Sprafkin, R. P., Gershaw, N. J., & Klein, P. (1997). Skillstreaming the adolescent: New strategies and perspectives for teaching prosocial skills, revised edition. Champaign, IL: Research Press.

  BACKGROUND

• 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.

  BACKGROUND

• Baron-Cohen, S., Golan, O., Wheelwright, S., & Hill, J. J. (2004). Mind reading: The intervention guide to emotions. London: Jessica Kingsley Limited (www.jkp.com).

  BACKGROUND

• White SW, Scahill L, Klin A, Koenig K, Volkmar FR. Educational placements and service use patterns of individuals with autism spectrum disorders. J Autism Dev Disord. 2007 Sep;37(8):1403-12. doi: 10.1007/s10803-006-0281-0. Epub 2006 Nov 3.

  PMID: 17082975 BACKGROUND

• Golan O, Baron-Cohen S. Systemizing empathy: teaching adults with Asperger syndrome or high-functioning autism to recognize complex emotions using interactive multimedia. Dev Psychopathol. 2006 Spring;18(2):591-617. doi: 10.1017/S0954579406060305.

  PMID: 16600069 BACKGROUND

• Constantino, J. N., & Gruber, C. P. (2012). Social Responsiveness Scale, Second Edition (SRS-2). Torrance, CA: Western Psychological Services.

  BACKGROUND

• Lopata C, Thomeer ML, Volker MA, Nida RE, Lee GK. Effectiveness of a manualized summer social treatment program for high-functioning children with autism spectrum disorders. J Autism Dev Disord. 2008 May;38(5):890-904. doi: 10.1007/s10803-007-0460-7.

  PMID: 18058012 BACKGROUND

• Lopata C, Thomeer ML, Volker MA, Toomey JA, Nida RE, Lee GK, Smerbeck AM, Rodgers JD. RCT of a manualized social treatment for high-functioning autism spectrum disorders. J Autism Dev Disord. 2010 Nov;40(11):1297-310. doi: 10.1007/s10803-010-0989-8.

  PMID: 20232240 BACKGROUND

• Woodcock, R. W., McGrew, K. S., & Mather, N. (2001). Woodcock-Johnson III Tests of Achievement. Itasca, IL: Riverside Publishing.

  BACKGROUND

• Bauminger N. The facilitation of social-emotional understanding and social interaction in high-functioning children with autism: intervention outcomes. J Autism Dev Disord. 2002 Aug;32(4):283-98. doi: 10.1023/a:1016378718278.

  PMID: 12199133 BACKGROUND

• Wechsler, D. (2003). Wechsler Intelligence Scale for Children (4th ed.). San Antonio, TX: The Psychological Corporation.

  BACKGROUND

• Carrow-Woolfolk, E. (1999). Comprehensive Assessment of Spoken Language. Circle Pines, MN: American Guidance Services.

  BACKGROUND

• Rutter, M., LeCouteur, A., & Lord, C. (2003). Autism Diagnostic Interview-Revised. Los Angeles: Western Psychological Services.

  BACKGROUND

• Lopata C, Thomeer ML, Rodgers JD, Donnelly JP, Lodi-Smith J. Longitudinal Follow-Up Study of Social Intervention Outcomes for Children on the Autism Spectrum. J Autism Dev Disord. 2025 Feb;55(2):393-407. doi: 10.1007/s10803-023-06221-1. Epub 2024 Feb 8.

  PMID: 38326493 DERIVED

• Lopata C, Thomeer ML, Rodgers JD, Donnelly JP, McDonald CA, Volker MA, Smith TH, Wang H. Cluster Randomized Trial of a School Intervention for Children with Autism Spectrum Disorder. J Clin Child Adolesc Psychol. 2019 Nov-Dec;48(6):922-933. doi: 10.1080/15374416.2018.1520121. Epub 2018 Oct 30.

  PMID: 30376652 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Christopher J Lopata, PsyD

  Institute for Autism Reseach, Canisius College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Child testing and behavioral observations were completed by evaluators blinded to treatment condition; evaluators consisted of advanced graduate students with training in the specific outcome measures
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The efficacy of the comprehensive school-based intervention (CSBI) was evaluated in a cluster randomized trial (pretest-posttest control group design). School buildings were randomly assigned to receive the CSBI or their typical educational programming. The CSBI was examined for its effect on the social performance/competence, ASD symptoms, and academic skills of children with HFASD compared to children with HFASD that did not receive the intervention. School staff delivered the multi-component intervention during the school year and research staff monitored intervention implementation (fidelity).

Study Record Dates

• First Submitted: November 2, 2017
• First Posted: November 9, 2017
• Study Start: August 1, 2013
• Primary Completion: July 31, 2017
• Study Completion: July 31, 2017
• Last Updated: November 9, 2017

Record last verified: 2017-11