Comparison of the Effectiveness of Group-based Music Therapy with Group-based Social Skills Training on Sensory Processing and Social Skills of Children with Autism Spectrum Disorder

To evaluate the effectiveness of a structured group-based music therapy program in improving sensory processing patterns and social skills in children aged 6–12 years with Autism Spectrum Disorder, compared to group-based social skills training without music.

Two‑arm, parallel‑group, randomized trial of 20 participants with open‑label intervention and blinded data analysis, single‑center.

The trial will take place at the Occupational Therapy Department of Imam Hossein Hospital in Tehran, Iran. Children will be recruited from outpatient clinics. It is an open-label trial for participants and therapists, but outcome assessment will be blinded, with an independent analyst conducting all analyses without knowing group allocation.

Inclusion criteria: - Children aged 6–12 years - Clinical diagnosis of ASD based on DSM-5 by a qualified child and adolescent psychiatrist - Stable physical health - Basic communication abilities for group participation - Informed consent from parent/legal guardian Exclusion criteria: - Uncontrolled neurological disorders (e.g., epilepsy) - Significant hearing or vision impairment - Severe behavioral problems preventing group participation - Participation in intensive music therapy in the past 6 months - Family unwillingness to attend scheduled sessions

Group-based music therapy program, 14 sessions (30–45 minutes each), including structured welcome and closing songs, rhythmic exercises, instrument playing, singing, and movement-based activities designed to stimulate sensory processing and promote social interaction.

Sensory processing profile score — measured with the Children’s Sensory Profile‑2 Social responsiveness score — measured with the Social Responsiveness Scale‑2

Participants will be randomly assigned to either the intervention or control group in a 1:1 allocation ratio using block randomization. A total of five blocks, each containing four participants, will be used to ensure balanced group sizes throughout enrollment. Within each block, two participants will be allocated to the intervention group and two to the control group, with the order of assignments randomized using a computer‑generated random number list in Excel. The randomization sequence will be prepared prior to enrollment by an independent researcher not involved in recruitment, assessment, or intervention delivery. Allocation concealment will be maintained using sequentially numbered, opaque, sealed envelopes (SNOSE), which will be opened only after confirming participant eligibility and completing baseline assessments.

Due to the use of parent‑reported outcome measures, blinding of participants and assessors is not feasible; however, data entry and statistical analysis will be conducted by personnel blinded to group allocation. Questionnaire scores will be entered into the dataset by researchers who are unaware of group allocation. Groups will be coded as “Group A” and “Group B” during analysis to ensure blinding of the data analyst.