Autism Spectrum DisorderNCT03267095
Use Music Therapy In Autism Spectrum Disorder
A study testing music therapy sessions . in people with Autism Spectrum Disorder, run by Assiut University.
Trial summary
Music therapy is an established form of creative art therapy. By using music as a specific medium of communication, expression and adapting it to the individual resources and abilities of the patient, music therapy can be beneficial in activating and supporting mental and psycho-physical recover . Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- music therapy sessions .
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2019to 1 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1.Age :3_7 2.Gender : both sex will be included in the study 3.IQ ≥75 4.children who will dignosed by an expert phoniatricist as having ASD
Who cannot join
- 1.Age >3 <7 2.IQ <75 . 3. children having other cause of DELAYED LANGUAGE DEVELOPMENT
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Use Of Music Therapy In Autism Spectrum Disorder
Music therapy is an established form of creative art therapy. By using music as a specific medium of communication, expression and adapting it to the individual resources and abilities of the patient, music therapy can be beneficial in activating and supporting mental and psycho-physical recover .
Read the detailed description
Students with developmental disabilities often have challenges in the areas of communication and social/emotional learning, which can lead to social isolation, problematic behaviors, and deficits in academic learning.These students have been found to respond well to the incorporation of music in intervention programs, in terms of both gains in communication skills and stronger social functioning . they respond more favorably and appropriately to music than other sensory stimuli
- Conditions
- Autism Spectrum Disorder
- Being tested
- music therapy sessions .
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
music therapy sessions .Behavioural
In this intervention songs compose by the therapist will be use for the study. The songs included the target word .The target words will be selecte from functional vocabularies that typically developing 3years old children can use effectively in everyday interactions.The general criteria for vocabulary words included: names of familiar objects and persons, functional action words such as words for social control , and emotional words . Inherent musical structures structures and organized musical patterns in the songs will be provide .The patients will reflect on the music therapy activity as singing the song together.
| Study group | Role | What they receive |
|---|---|---|
| Study | Experimental | .Patient in stduy Arm will receive music therapy sessions Receives: Behavioral: music therapy sessions . |
| Control | No intervention | Patient in control Arm will have cosuling for mother and follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Arabic Language test
The Arabic Language test:
language score is the sum of the total scores of: Test of semantics Test of expressive morphology Test of syntax Test of pragmatics
Measured: Baseline,Change from Baseline at the end of 12 Months Music Therapy .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start1 Oct 2019 (estimated)
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mylove Amira, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03267095
- Sponsor's protocol ID
- MTH ASD
- Status last verified
- Jul 2019
- First submitted
- 24 Aug 2017
- Last updated
- 23 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gold C, Voracek M, Wigram T. Effects of music therapy for children and adolescents with psychopathology: a meta-analysis. J Child Psychol Psychiatry. 2004 Sep;45(6):1054-63. doi: 10.1111/j.1469-7610.2004.t01-1-00298.x.
PubMed 15257662Geretsegger M, Fusar-Poli L, Elefant C, Mossler KA, Vitale G, Gold C. Music therapy for autistic people. Cochrane Database Syst Rev. 2022 May 9;5(5):CD004381. doi: 10.1002/14651858.CD004381.pub4.
PubMed 35532041
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use Of Music Therapy In Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT03267095
- Acronym / sponsor ID
- MTH ASD
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 30 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Music therapy is an established form of creative art therapy. By using music as a specific medium of communication, expression and adapting it to the individual resources and abilities of the patient, music therapy can be beneficial in activating and supporting mental and psycho-physical recover .
Detailed description
Students with developmental disabilities often have challenges in the areas of communication and social/emotional learning, which can lead to social isolation, problematic behaviors, and deficits in academic learning.These students have been found to respond well to the incorporation of music in intervention programs, in terms of both gains in communication skills and stronger social functioning . they respond more favorably and appropriately to music than other sensory stimuli
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study | Experimental | Behavioral: music therapy sessions ..Patient in stduy Arm will receive music therapy sessions |
| Control | No intervention | –Patient in control Arm will have cosuling for mother and follow up |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1.Age :3_7 2.Gender : both sex will be included in the study 3.IQ ≥75 4.children who will dignosed by an expert phoniatricist as having ASD
Key exclusion criteria (1 listed)
- 1.Age >3 <7 2.IQ <75 . 3. children having other cause of DELAYED LANGUAGE DEVELOPMENT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| music therapy sessions .In this intervention songs compose by the therapist will be use for the study. The songs included the target word .The target words will be selecte from functional vocabularies that typically developing 3years old children can use effectively in everyday interactions.The general criteria for vocabulary words included: names of familiar objects and persons, functional action words such as words for social control , and emotional words . Inherent musical structures structures and organized musical patterns in the songs will be provide .The patients will reflect on the music therapy activity as singing the song together. | Behavioural | Study |
Primary outcome
The Arabic Language test
Time frame: Baseline,Change from Baseline at the end of 12 Months Music Therapy .
The Arabic Language test: language score is the sum of the total scores of: Test of semantics Test of expressive morphology Test of syntax Test of pragmatics
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- Background: PubMed 15257662Gold C, Voracek M, Wigram T. Effects of music therapy for children and adolescents with psychopathology: a meta-analysis. J Child Psychol Psychiatry. 2004 Sep;45(6):1054-63. doi: 10.1111/j.1469-7610.2004.t01-1-00298.x.
- Derived from this study: PubMed 35532041Geretsegger M, Fusar-Poli L, Elefant C, Mossler KA, Vitale G, Gold C. Music therapy for autistic people. Cochrane Database Syst Rev. 2022 May 9;5(5):CD004381. doi: 10.1002/14651858.CD004381.pub4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing music therapy sessions . in people with Autism Spectrum Disorder, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact EMAD KAML (01064228598, emad.ibrahim@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Arabic Language test (time frame: Baseline,Change from Baseline at the end of 12 Months Music Therapy .). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03267095, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.