Adaptive Intervention for School-Age, Minimally Verbal Children With Autism Spectrum Disorder in the Community: Primary Aim Results.

Objective: The goal of this study is to construct a 16-week, two-stage, adaptive intervention consisting of DTT ([discrete trials training], largely considered usual care for children with autism), JASP-EMT (a blended, naturalistic, developmental behavioral intervention involving JASPER [joint attention, symbolic play, engagement and regulation] and EMT [enhanced milieu teaching]), and parent training (P) for improving spontaneous, communicative utterances in school-aged, minimally verbal autistic children. Intervention was delivered both at school (DTT, JASP-EMT) and home (P). This manuscript reports results for the study's primary aim and a closely related secondary aim.

Method: The study used a two-stage, sequential, multiple-assignment randomized trial design. In stage 1 (weeks 1-6), 194 minimally verbal (< 20 functional words), 5-8 year- old autistic children were randomized initially to DTT vs. JASP-EMT (stage 1, weeks 0-6). Early vs slower response status was determined at the end of stage 1. In stage 2 (weeks 7-16), early responders were re-randomized to stay the course vs. P; whereas, slow responders were re-randomized to stay the course vs. combined DTT+JASP-EMT). The primary aim was to test whether there is a difference between starting with DTT vs. starting with JASP-EMT on average change in socially communicative utterances (SCU; primary outcome) from baseline to week 16. A secondary aim was to estimate which of the 8 pre-specified interventions was most favorable (i.e., the largest average SCU at week 16). The secondary outcomes were: total number of novel words, joint engagement, play diversity, requesting and joint attention gestures from independent, blinded assessments.

Results: There was no evidence to reject the null hypothesis of no difference between starting with DTT or JASP-EMT on primary outcome (p=0.41). The most favorable of the 8 interventions was the adaptive intervention which starts with DTT, augments with P for early responders, and augments with JASP-EMT for slow responders. For this adaptive intervention, average change on SCU from baseline to week 16 for this intervention was estimated to be 7.68 (95%CI 2.13 to 13.24).

Conclusion: The results showed no difference in treatment starting with JASP-EMT or DTT and the differences between the eight adaptive interventions of the secondary aim were modest. Based on these results, reflections on next steps are discussed.