Effects of group-based music therapy combined with speech therapy on language and social skills in preschool children with autism spectrum disorder: An exploratory randomized controlled trial.

BACKGROUND: Autism spectrum disorder (ASD) is characterized by early difficulties in language and social communication. While speech therapy is a core early intervention, music therapy has been increasingly applied to support social-emotional development. However, evidence regarding the additive effects of group-based music therapy combined with speech therapy in preschool children with ASD remains limited.

METHOD: This exploratory randomized controlled trial enrolled (RCT) preschool children aged 3-5 years with ASD and language delay. Participants were randomly assigned to a Music Therapy group receiving group-based music therapy (60 min/week) plus individual speech therapy (30 min/week), or a Control group receiving speech therapy alone, for 8 weeks. The primary outcome was week 8 language performance assessed using the Preschool Language Scale (PLS). Secondary outcomes included autism-related characteristics, emotional and behavioral functioning, and parenting stress, assessed using the Checklist for Autism Spectrum Disorder-Chinese Version (CASD-C), Pervasive Developmental Problems scale of the Child Behavior Checklist for Ages 1½-5 (CBCL 1½-5 PDP), and Parenting Stress Index-Short Form (PSI-4-SF), respectively. The primary treatment effect was evaluated using a multiple imputation-based intention-to-treat (ITT) adjusted analysis accounting for sex and baseline outcome measures. Secondary outcome analyses were interpreted with Benjamini-Hochberg false discovery rate correction for multiple comparisons. Exploratory within-group analyses and generalized estimating equation (GEE) models were used to characterize observed changes over time.

RESULTS: Forty participants were randomized, and 38 participants completed the week 8 assessment. The ITT analysis included all randomized participants. Observed PLS total scores increased significantly within both groups. Exploratory within-group analyses also showed reductions in CASD-C social interaction issues and emotional difficulties in the Music Therapy group, and CBCL 1½-5 PDP T-scores decreased within both groups. However, the primary adjusted ITT analysis did not demonstrate statistically significant superiority of adjunctive group-based music therapy over speech therapy alone for the primary language outcome (adjusted between-group difference, -1.65; 95% confidence interval, -7.52-4.21; p = 0.569). No statistically significant adjusted between-group differences were observed for secondary outcomes. Exploratory GEE analyses indicated time-related changes in PLS total score, CASD-C sensory difficulties, and CBCL 1½-5 PDP T-score, but no significant group-by-time interactions.

CONCLUSION: In this exploratory RCT, group-based music therapy was feasible to integrate with speech therapy and was not associated with intervention-related adverse events. Although language performance and selected autism-related behavioral features showed improvements over time, adjunctive group-based music therapy did not demonstrate statistically significant superiority over speech therapy alone. Larger adequately powered trials are needed to evaluate its incremental benefit.