NCT06996795

Brief Summary

The purpose of our study is to examine the effects of music therapy on sensory processing, adaptive behavior, and social interaction in individuals with autism.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 30, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
Last Updated

July 31, 2025

Status Verified

July 1, 2025

Enrollment Period

1 month

First QC Date

May 21, 2025

Last Update Submit

July 30, 2025

Conditions

Keywords

autismsensory integrationmusic therapysensory processingsocial interaction

Outcome Measures

Primary Outcomes (1)

  • sensory profile

    Sensory Profile: This assessment tool is used to determine the sensory profiles of children between the ages of 3-10. The test consists of 125 questions and a parent/caregiver with whom the child has one-on-one communication in his/her daily life answers the test questions. The test consists of three main sections: sensory processing, modulation and behavioral and emotional responses. The subsections of each main section consist of a total of 14 sections and 125 questions. The test takes approximately 30 minutes to administer. You are asked to mark one of the options: always, often, sometimes, occasionally and never. The assessment results are found by scoring from 1 to 5, giving 5 points to "never" and 1 point to "always". In this assessment, 1 point reflects a situation where there is a disordered behavior related to the sensory profile and 5 points reflects a situation where there is normal behavior. The Turkish adaptation of this test was made.

    1 month

Secondary Outcomes (1)

  • Adaptive Behavior Scale

    1 month

Study Arms (2)

sensory integration training and music therapy

ACTIVE COMPARATOR

The intervention group will receive both sensory integration training and music therapy. Sensory integration will include sensory modulation activities, vestibular, proprioceptive, tactile, visual and auditory sensory studies. Music therapy will be applied with drums, maracas, cymbals and orf instruments. It will consist of body rhythms, breathing exercises and rhythm studies.

Behavioral: music therapyBehavioral: sensory integration

sensory integration training

ACTIVE COMPARATOR

The control group will receive sensory integration training. Sensory integration will include sensory modulation activities, vestibular, proprioceptive, tactile, visual and auditory sensory studies.

Behavioral: sensory integration

Interventions

music therapyBEHAVIORAL

Music therapy will be applied with drums, maracas, cymbals and orf instruments. It will consist of body rhythms, breathing exercises and rhythm studies.

sensory integration training and music therapy

Sensory integration will include sensory modulation activities, vestibular, proprioceptive, tactile, visual and auditory sensory studies.

sensory integration trainingsensory integration training and music therapy

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Having been diagnosed with autism spectrum disorder (ASD) by a child psychiatrist Being between the ages of 6-10 being able to cooperate

You may not qualify if:

  • Having any neurological, orthopedic or psychiatric diagnosis in addition to autism diagnosis Having undergone any surgical intervention in the last 3 months Being inadequate in understanding visual and auditory commands Having a visual and hearing impairment recorded in the health report

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Autistic Disorder

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The therapist who conducted the assessment tests was unaware of the participants' group assignments (interventon or control)
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Two groups with an intervention group and a control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 21, 2025

First Posted

May 30, 2025

Study Start

July 1, 2025

Primary Completion

August 1, 2025

Study Completion

August 30, 2025

Last Updated

July 31, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations