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

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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. 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. 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). 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.