Sensory Regulation–Based Classroom Strategies for Reducing Anxiety and Behavioral Challenges in Children with Autism: A Pragmatic Cluster-Randomized Trial

Abstract

Anxiety and behavior dysregulation are common barriers to learning for students with ASD. Sensory over-responsivity and state regulation challenges often increase classroom stressors. While sensory-based supports are commonly utilized in schools, few rigorous, classroom-level studies with implementation detail exist. We conducted a pragmatic, cluster-randomized controlled trial across 36 elementary classrooms (grades 1–4) in inclusive and specialized settings. Classrooms were randomized 1:1 to a 12-week Sensory Regulation Classroom Package (SRCP) or business-as-usual (BAU). SRCP comprised six components: (1) environmental zoning with low-stimulation “calm corners”; (2) brief, scheduled proprioceptive/vestibular “sensory-diet” breaks; (3) visual interoceptive self-monitoring tools; (4) soundscaping with steady-state noise dampening; (5) movement-integrated transition routines; and (6) teacher training with weekly coaching and fidelity checks. Participants were 216 students with autism (mean age 8.4 years; 72% male). The primary outcome was teacher-rated school anxiety (School Anxiety Scale–Teacher Report; SAS-TR) at 12 weeks. Secondary outcomes included irritability (Aberrant Behavior Checklist–Irritability, ABC-I), off-task behavior (proportion of interval-coded minutes), meltdown frequency (count per week), and heart rate variability (RMSSD). Assessments occurred at baseline (T0), 6 weeks (T1), 12 weeks (T2), and 8-week follow-up (T3). Intention-to-treat analyses used mixed-effects models with random intercepts for classroom and student. Prespecified mediation tested whether changes in sensory modulation (Sensory Profile–School Companion index) explained anxiety reduction. Baseline characteristics were balanced. Intervention fidelity averaged 86% (SD 9). At 12 weeks, SRCP yielded lower SAS-TR scores than BAU (adjusted mean difference -3.8, 95% CI -5.4 to -2.2; standardized d = 0.45). Clinically meaningful anxiety improvement (≥20% reduction) occurred in 49% of SRCP vs 27% of BAU students (risk ratio 1.81; number needed to treat ≈ 5). Secondary outcomes favored SRCP: ABC-I decreased (-5.2 points, 95% CI -7.4 to -3.0), off-task behavior decreased by 21% (relative), meltdown frequency fell (incidence rate ratio 0.66, 95% CI 0.54-0.81), and RMSSD increased (+12 ms, 95% CI +6 to +18). Benefits persisted at T3 with partial attenuation. Mediation analysis indicated that 38% (95% CI 22–56) of the anxiety reduction was explained by improved sensory modulation. Effects were larger in students with baseline sensory over-responsivity and in classrooms with higher ambient noise. No serious adverse events occurred. A low-cost, multicomponent sensory regulation package improved anxiety and behavior outcomes in elementary classrooms serving students with autism. Gains were partially mediated by better sensory modulation, supporting a mechanistic pathway from environmental and proprioceptive supports to arousal regulation and functional behavior. Pragmatic implementation with coaching and fidelity monitoring appears feasible and beneficial.