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Interagency Autism Coordinating Committee (IACC)
Autism Research Database
Office of Autism Research Coordination (OARC)
 
Project Element Element Description

Project Title

Project Title

Clinical Trial of a Comprehensive Treatment for High-Functioning Children with ASD

Principal Investigator

Principal Investigator

Lopata, Christopher

Description

Description

Rationale: Children with high-functioning autism spectrum disorder (HFASD) exhibit a range of complex clinical and associated features that require comprehensive psychosocial treatment packages. These should target both core features of the disorder (symptom reduction) and development of adaptive skills. Few programs have been developed and rigorously studied and found to yield robust treatment effects for children with HFASD. Lopata, Thomeer, and colleagues developed a comprehensive psychosocial treatment, delivered in a summer program format (summerMAX) for children with HFASD. This manualized summer treatment has been validated in a series of increasingly controlled studies including two randomized clinical trials (RCTs). The summer program was adapted into a school-based model (schoolMAX) that also yielded similar gains for children with HFASD. Both the summer and school-based models significantly reduced ASD symptoms and increased adaptive social-communicative functioning of children with HFASD. Given the positive effects of the summer and school-based treatments, the model was recently adapted into a comprehensive outpatient model (MAXout) and evaluated in a pilot study with 28 children with HFASD. Results of the outpatient pilot study supported the feasibility of the treatment protocol (high levels of treatment fidelity, and parent and child satisfaction), and pre-post comparisons indicated a significant decrease in ASD symptoms and increase in social/social communication skills. At present, there are no validated comprehensive outpatient treatments specifically for children with HFASD. Results of the pilot study suggest that the comprehensive outpatient treatment MAXout may be an effective program and should be studied in an RCT. Objective: The objective is to test the efficacy of an outpatient comprehensive psychosocial treatment (MAXout) on the ASD symptoms and social-communicative functioning of 7-12 year-olds with HFASD. The manualized outpatient treatment targets social/social-communication skills, interpretation of non-literal language skills, emotion-decoding skills, and interest expansion. Treatment is delivered over 18 weeks (two 90-minute sessions per week) with each treatment group consisting of four children with HFASD and two staff clinicians. The treatment protocol utilizes direct instruction, modeling, role-play (rehearsal), performance feedback (reinforcement), transfer of learning (generalization), and repeated practice to foster skills acquisition and maintenance and reduce ASD symptoms. The intensity of this outpatient model substantially exceeds that of other outpatient treatments, which have generally yielded small/very modest and narrow treatment effects. Type of patients targeted and benefits: The patients targeted in this trial are children, ages 7-12 years with HFASD. Benefits -- results from the pilot study of the outpatient protocol indicated significantly reduced clinical symptoms and increased social-communicative functioning. It is anticipated that children with HFASD will exhibit significant post-treatment reductions in ASD symptoms and increases in adaptive social-communicative functioning. Potential clinical applications, benefits, and risks: The protocol to be tested is a psychosocial treatment and it will be studied as a clinical application. Evidence of efficacy will support its use as a clinical program. Potential clinical benefits consist of immediate reductions in ASD symptoms and increases in social-communicative functioning. Clinical risks are consistent with typical psychosocial interventions in which children with HFASD learn and practice skills that are challenging for them. In the outpatient treatment, skills instruction and therapeutic activities have been designed to be fun and engaging, with high levels of staff support. Impact of project on ASD research and patient care: At present, there are no manualized comprehensive treatment models for children with HFASD that have been studied and validated in multiple delivery formats. This project will contribute to ASD research by serving as a model for development, adaptation, and rigorous evaluation of comprehensive psychosocial treatments for children with HFASD/ASD in different delivery formats. The project will also contribute to ASD research as few RCTs have been completed on outpatient psychosocial treatments for these children. The impact on patient care is clearly evident. The outpatient protocol contains all the dosage parameters, treatment content and procedures, fidelity procedures and measures, staff training curriculum, and data recording templates. The manualized nature of the outpatient model makes it highly exportable and replicable. This has clinical implications for providers treating the core impairments of children with HFASD as few manualized treatment packages have been validated. Evidence of efficacy will also make this treatment model the only one for children with HFASD validated in outpatient, summer, and school-based formats. The ability to provide the treatment in differing formats has obvious clinical utility for a range of service providers.

Funder

Funder

Department of Defense - Army

Fiscal Year Funding

Fiscal Year Funding

1338504

Current Award Period

Current Award Period

2015-2019

Strategic Plan Question

Strategic Plan Question

Question 4: Which Treatments And Interventions Will Help?

Strategic Plan Objective

Strategic Plan Objective

Yellow dot: Objective has some degree of funding, but less than the recommended amount. 4SF. Launch randomized controlled trials of interventions including biological signatures and other measures to predict response, and monitor quality of life and functional outcomes in each of the following groups: o Five trials in infants and toddlers by 2013. IACC Recommended Budget: $30,000,000 over 5 years. o Three trials in school-aged children and/or adolescents by 2013. IACC Recommended Budget: $18,000,000 over 5 years. o Three trials in adults by 2014. IACC Recommended Budget: $18,000,000 over 5 years.

Project Link

Project Link

Clinical Trial of a Comprehensive Treatment for High-Functioning Children with ASD (External web link)

Institution

Institution

Canisius College

State/Country

State/Country

New York

Project Number

Project Number

AR140069

Federal or Private?

Federal or Private?

Federal

Received ARRA Funding?

Received ARRA Funding?

No

History/Related Projects

History/Related Projects

Clinical Trial of a Comprehensive Treatment for High-Functioning Children with ASD | 0 | 2015 | AR140069

 
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