Ignite Creation Date:
2025-12-24 @ 2:05 PM
Ignite Modification Date:
2025-12-25 @ 12:48 PM
Study NCT ID:
NCT06996795
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-07-31
First Post:
2025-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Music Therapy on Sensory Processing, Adaptive Behavior and Social Interaction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001321', 'term': 'Autistic Disorder'}], 'ancestors': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009147', 'term': 'Music Therapy'}], 'ancestors': [{'id': 'D026421', 'term': 'Sensory Art Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': "The therapist who conducted the assessment tests was unaware of the participants' group assignments (interventon or control)"}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two groups with an intervention group and a control group'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-30', 'studyFirstSubmitDate': '2025-05-21', 'studyFirstSubmitQcDate': '2025-05-21', 'lastUpdatePostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sensory profile', 'timeFrame': '1 month', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Adaptive Behavior Scale', 'timeFrame': '1 month', 'description': 'Adaptive Behavior Scale (ABS): The scale evaluates the child\'s adaptive behavior according to two basic criteria: the person\'s possession of basic skills such as self-care and personal hygiene, and avoiding behaviors that are not accepted by the environment, such as harming others and using physical violence. The Turkish validity study of the Adaptive Behavior Scale was conducted. The Adaptive Behavior Scale consists of two sections. The first section evaluates the skills and habits in nine behavioral areas that are important for the individual\'s development of independence in daily life. The second section is designed to measure non-adaptive behavior related to personality and behavioral disorders. If the behavior occurs "occasionally", "1" is marked, and if it occurs "frequently", "2" is marked. 25-30 minutes is considered sufficient for the application of the scale.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['autism', 'sensory integration', 'music therapy', 'sensory processing', 'social interaction'], 'conditions': ['Music Therapy']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'The study was designed as a randomized controlled trial. A simple randomization method will be used to randomly assign individuals to two groups (intervention and control groups). A simple randomization method will be used where the intervention and control group papers are selected from a sealed envelope. Following the initial assessment of each participant, one of the papers labeled "intervention" or "control" will be randomly selected. This decision will determine whether the individual will be assigned to the intervention or control group. The study will be conducted at Hacettepe University. The study group and the control group will receive sensory integration training for 45 minutes per day, 2 days per week, for 6 weeks. The children in the control group will receive only sensory integration training, while the study group will receive music therapy training for 30 minutes per day, 2 days per week, for 6 weeks in addition to sensory integration training. Sociodemographic information of the children will be collected before the research and sensory processing problems of the children will be assessed with the Sensory Profile and adaptive behavioral skills will be assessed with the Adaptive Behavior Scale (ADS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHaving been diagnosed with autism spectrum disorder (ASD) by a child psychiatrist Being between the ages of 6-10 being able to cooperate\n\nExclusion Criteria:\n\nHaving 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'}, 'identificationModule': {'nctId': 'NCT06996795', 'briefTitle': 'Effects of Music Therapy on Sensory Processing, Adaptive Behavior and Social Interaction', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Investigating the Effects of Music Therapy on Sensory Processing, Adaptive Behavior and Social Interaction in Children With Autism', 'orgStudyIdInfo': {'id': 'HÜ-OT-LKO-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'sensory integration training and music therapy', 'description': '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.', 'interventionNames': ['Behavioral: music therapy', 'Behavioral: sensory integration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'sensory integration training', 'description': 'The control group will receive sensory integration training. Sensory integration will include sensory modulation activities, vestibular, proprioceptive, tactile, visual and auditory sensory studies.', 'interventionNames': ['Behavioral: sensory integration']}], 'interventions': [{'name': 'music therapy', 'type': 'BEHAVIORAL', 'description': 'Music therapy will be applied with drums, maracas, cymbals and orf instruments. It will consist of body rhythms, breathing exercises and rhythm studies.', 'armGroupLabels': ['sensory integration training and music therapy']}, {'name': 'sensory integration', 'type': 'BEHAVIORAL', 'description': 'Sensory integration will include sensory modulation activities, vestibular, proprioceptive, tactile, visual and auditory sensory studies.', 'armGroupLabels': ['sensory integration training', 'sensory integration training and music therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06800', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Hacettepe University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Leyla Kaya Ozturk', 'investigatorAffiliation': 'Hacettepe University'}}}}