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.