Work

In-person UCLA-PEERS® program for adolescents with autism spectrum disorder in Italy: study protocol for a pilot and feasibility randomized controlled trial with pragmatic features and exploratory EEG markers of treatment response

Year: 2026

Type: article

Abstract: Background Adolescents with Autism Spectrum Disorder (ASD) Level 1 frequently experience persistent difficulties in peer relationships and social functioning that become more evident as social demands increase. Group-based social skills trainings represent a key evidence-based intervention for this population, yet its availability in routine clinical services is still limited. The Program for the Education and Enrichment of Relational Skills (PEERS ® ) is one of the most empirically supported interventions for autistic adolescents. In Italy, telemedicine delivery has shown promising results, but the effectiveness and implementation of the in-person format in real-world services have not yet been evaluated. In addition, predictors of individual response to psychosocial interventions remain largely unknown. Methods This study is designed as a two-arm pilot and feasibility randomized controlled trial incorporating pragmatic features, including delivery within a routine tertiary clinical service, comparison with Treatment as Usual (TAU), and allowance for ongoing concomitant clinical, educational, and pharmacological treatments. It will compare the in-person Italian adaptation of UCLA PEERS ® with Treatment as Usual (TAU) at IRCCS Fondazione Stella Maris (Pisa, Italy). Thirty-six adolescents aged 11–13 years with ASD (DSM-5-TR) and Full-Scale IQ >85 will be assessed at baseline (T0) and after the 16-week intervention (T1). Randomization will use block allocation with allocation concealment until completion of baseline assessments; outcome assessors and independent ADOS–BOSCC video coders will remain blind to group assignment. The intervention includes sixteen weekly 90-minute group sessions delivered by certified providers, with parallel caregiver sessions and structured teacher contacts to promote generalization. The primary focus of this pilot trial is feasibility, assessed through recruitment, retention, session attendance, and treatment fidelity. Clinical outcomes will be examined exploratorily to provide preliminary estimates of treatment effects. The QSQ-R will serve as the prespecified principal clinical outcome for estimating change in social functioning from baseline to T1. Parent- and adolescent-report versions will be analyzed separately, considering the Social Initiative and Social Reciprocity dimensions as distinct outcomes rather than deriving a composite total score. Key secondary outcomes include social knowledge (TASSK-R), autism-related social responsiveness (SRS-2), social motivation (SSDS), social anxiety (SAS), and observational change in social-communication behaviors (ADOS–BOSCC). Emotional–behavioral functioning (CBCL; YSR) will be explored as additional secondary outcomes. Baseline electroencephalography (EEG) recorded during a gesture–word integration task will be used to derive the N400 congruency effect and to explore whether individual differences in this measure are associated with treatment response. As a pilot and feasibility trial, the study is not powered for definitive efficacy testing and will estimate feasibility, acceptability, fidelity, and preliminary effect sizes to inform future multicenter trials. Discussion This study will provide the first evaluation of in-person PEERS ® in the Italian clinical context and test the generalizability of previous telemedicine findings in routine care. The integration of clinical and behavioral outcomes may contribute to mechanism-informed, personalized psychosocial interventions for autistic adolescents and guide the design of future confirmatory studies. Trial registration (ClinicalTrials.gov - NCT07207213 – October, 3, 2025).

Source: Frontiers in Psychiatry

DOI: 10.3389/fpsyt.2026.1988518