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IRCT20250325065158N1 IRCT 2025-10-08 Shahid Beheshti University of Medical Sciences Effects of Group-Based Music Therapy on Sensory Processing and Social Skills of Children with Autism Spectrum Disorder 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 2025-10-23 anticipated 20 Complete https://irct.ir/trial/86216 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: 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, Blinding description: 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. N/A Autism Spectrum Disorder. Intervention 1: Intervention group: This group‑based intervention will be delivered by a qualified music therapist over 14 sessions, each lasting 30–45 minutes, twice per week, in a therapy room equipped with simple musical instruments (e.g., drums, tambourine, xylophone, bells, small percussion). The overall approach combines improvisational music therapy with structured activities, focusing on improving social interaction, joint attention, communication skills, and sensory regulation. Each session will begin with a fixed “hello” song and end with a fixed “goodbye” song to provide structure and predictability for the children. Session 1: Introduction and rapport‑building — instrument introduction, hello song with child’s name, free exploration of instruments, goodbye song. Session 2: Musical turn‑taking — “passing the beat” in a circle, imitating rhythms, turn‑taking with different instruments.Session 3: Call‑and‑response singing — therapist sings short phrases for the child to repeat, incorporating names and emotions. Session 4: Rhythmic synchrony — group drumming to a steady beat, gradually increasing rhythmic complexity. Session 5: Musical storytelling — creating a simple story with sound effects (e.g., rainstick for rain, drum for thunder).Session 6: Emotions in music — playing musical excerpts with different moods (happy, sad, angry) and discussing feelings. Session 7: Instrument choice and leadership — each child chooses an instrument and leads a short group improvisation. Session 8: Sensory regulation through music — alternating stimulating (fast, loud) and calming (slow, soft) music to teach self‑regulation. Session 9: Duet improvisations — therapist pairs with each child for short improvisations focusing on matching and responding. Session 10: Group composition — creating a short song together on a theme such as friendship or the group experience. Session 11: Performance preparation — rehearsing favorite songs/activities for a final sharing session. Sessions 12–14: Group sharing and closure — short performance for parents or peers, feedback, and formal goodbye. Intervention 2: Control group: Participants in the control group will receive a structured social skills training program, delivered in 14 group sessions of 30–45 minutes each, held twice per week over seven weeks. Sessions will be conducted by a certified occupational therapist in a quiet therapy room with minimal sensory distractions. Each session will follow a consistent format of greeting, targeted activities, and closing summary. Session 1 will focus on introductions, rapport building, and establishing group rules. Session 2 will address greeting skills through role‑play and eye contact practice. Session 3 will target turn‑taking using games and “talking stick” activities. Session 4 will develop active listening through “repeat back” tasks and short story comprehension. Session 5 will encourage sharing via cooperative play and group art projects. Session 6 will teach expressing feelings using emotion cards and charades, while Session 7 will focus on understanding others’ emotions through perspective‑taking and facial expression matching. Session 8 will practice asking for help in various scenarios, and Session 9 will promote giving compliments through structured peer feedback. Session 10 will teach joining group activities politely, and Session 11 will address problem solving using social scenarios and brainstorming. Session 12 will reinforce following group plans through a cooperative project with assigned roles. Session 13 will review and practice all skills through rotating activity stations, and Session 14 will provide closure with group reflection, feedback, and a certificate ceremony. Activities will include role‑plays, cooperative games, storytelling, and group projects, supported by visual aids and scenario cards. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Once the article is published, all the information and data and results will be available to everyone.
public Benyamin Hamid
School of rehabilitation of Shahid Beheshti university of medical sciences, Damavand St., Imam Hussein Sq.
Tehran Iran (Islamic Republic of) 1616913111 +98 21 7756 1721 benyamin-hamid@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Navid Mirzakhany Araghi
School of Rehabilitation of Shahid Beheshti University of Medical Sciences,Damavand St., Imam Hussein Sq., Tehran, Iran
Tehran Iran (Islamic Republic of) 1616913111 +98 21 7756 1721 mirzakhany@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Children aged 6-12 years Clinical diagnosis of Autism Spectrum Disorder based on DSM-5 by a registered child and adolescent psychiatrist Stable physical health Basic communication abilities for group participation Informed consent from parent/legal guardian 6 years 12 years Both 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 F84.0 Autistic disorder Rehabilitation Rehabilitation Intervention group: This group‑based intervention will be delivered by a qualified music therapist over 14 sessions, each lasting 30–45 minutes, twice per week, in a therapy room equipped with simple musical instruments (e.g., drums, tambourine, xylophone, bells, small percussion). The overall approach combines improvisational music therapy with structured activities, focusing on improving social interaction, joint attention, communication skills, and sensory regulation. Each session will begin with a fixed “hello” song and end with a fixed “goodbye” song to provide structure and predictability for the children. Session 1: Introduction and rapport‑building — instrument introduction, hello song with child’s name, free exploration of instruments, goodbye song. Session 2: Musical turn‑taking — “passing the beat” in a circle, imitating rhythms, turn‑taking with different instruments.Session 3: Call‑and‑response singing — therapist sings short phrases for the child to repeat, incorporating names and emotions. Session 4: Rhythmic synchrony — group drumming to a steady beat, gradually increasing rhythmic complexity. Session 5: Musical storytelling — creating a simple story with sound effects (e.g., rainstick for rain, drum for thunder).Session 6: Emotions in music — playing musical excerpts with different moods (happy, sad, angry) and discussing feelings. Session 7: Instrument choice and leadership — each child chooses an instrument and leads a short group improvisation. Session 8: Sensory regulation through music — alternating stimulating (fast, loud) and calming (slow, soft) music to teach self‑regulation. Session 9: Duet improvisations — therapist pairs with each child for short improvisations focusing on matching and responding. Session 10: Group composition — creating a short song together on a theme such as friendship or the group experience. Session 11: Performance preparation — rehearsing favorite songs/activities for a final sharing session. Sessions 12–14: Group sharing and closure — short performance for parents or peers, feedback, and formal goodbye. Control group: Participants in the control group will receive a structured social skills training program, delivered in 14 group sessions of 30–45 minutes each, held twice per week over seven weeks. Sessions will be conducted by a certified occupational therapist in a quiet therapy room with minimal sensory distractions. Each session will follow a consistent format of greeting, targeted activities, and closing summary. Session 1 will focus on introductions, rapport building, and establishing group rules. Session 2 will address greeting skills through role‑play and eye contact practice. Session 3 will target turn‑taking using games and “talking stick” activities. Session 4 will develop active listening through “repeat back” tasks and short story comprehension. Session 5 will encourage sharing via cooperative play and group art projects. Session 6 will teach expressing feelings using emotion cards and charades, while Session 7 will focus on understanding others’ emotions through perspective‑taking and facial expression matching. Session 8 will practice asking for help in various scenarios, and Session 9 will promote giving compliments through structured peer feedback. Session 10 will teach joining group activities politely, and Session 11 will address problem solving using social scenarios and brainstorming. Session 12 will reinforce following group plans through a cooperative project with assigned roles. Session 13 will review and practice all skills through rotating activity stations, and Session 14 will provide closure with group reflection, feedback, and a certificate ceremony. Activities will include role‑plays, cooperative games, storytelling, and group projects, supported by visual aids and scenario cards. Sensory processing patterns. Timepoint: Before intervention, immediately and 2 weeks after intervention. Method of measurement: Children's Sensory Profile - 2. Social Skills. Timepoint: Before intervention, immediately and 2 weeks after intervention. Method of measurement: Social Responsiveness Scale - 2. Symptoms of Autism Spectrum Disorder. Timepoint: Before intervention, immediately, and 2 weeks after intervention. Method of measurement: Gilliam Autism Rating Scale - 3. Shahid Beheshti University of Medical Sciences Approved 2025-09-14 Research Ethics Committee of Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Sciences HQ., Erabi St., Daneshjoo Blvd., Velenjak Tehran Tehran Iran (Islamic Republic of)