<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03267095</url>
  </required_header>
  <id_info>
    <org_study_id>MTH ASD</org_study_id>
    <nct_id>NCT03267095</nct_id>
  </id_info>
  <brief_title>Use Music Therapy In Autism Spectrum Disorder</brief_title>
  <official_title>The Use Of Music Therapy In Autism Spectrum Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Music therapy is an established form of creative art therapy. By using music as a specific&#xD;
      medium of communication, expression and adapting it to the individual resources and abilities&#xD;
      of the patient, music therapy can be beneficial in activating and supporting mental and&#xD;
      psycho-physical recover .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Students with developmental disabilities often have challenges in the areas of communication&#xD;
      and social/emotional learning, which can lead to social isolation, problematic behaviors, and&#xD;
      deficits in academic learning.These students have been found to respond well to the&#xD;
      incorporation of music in intervention programs, in terms of both gains in communication&#xD;
      skills and stronger social functioning . they respond more favorably and appropriately to&#xD;
      music than other sensory stimuli&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 1, 2019</start_date>
  <completion_date type="Anticipated">November 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Arabic Language test</measure>
    <time_frame>Baseline,Change from Baseline at the end of 12 Months Music Therapy .</time_frame>
    <description>The Arabic Language test:&#xD;
language score is the sum of the total scores of: Test of semantics Test of expressive morphology Test of syntax Test of pragmatics</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Autism Spectrum Disorder</condition>
  <arm_group>
    <arm_group_label>Study</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>.Patient in stduy Arm will receive music therapy sessions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patient in control Arm will have cosuling for mother and follow up</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>music therapy sessions .</intervention_name>
    <description>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.</description>
    <arm_group_label>Study</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1.Age :3_7 2.Gender : both sex will be included in the study 3.IQ ≥75 4.children who&#xD;
             will dignosed by an expert phoniatricist as having ASD&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1.Age &gt;3 &lt;7 2.IQ &lt;75 . 3. children having other cause of DELAYED LANGUAGE DEVELOPMENT&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>7 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>EMAD KAML</last_name>
    <phone>01064228598</phone>
    <email>emad.ibrahim@med.au.edu.eg</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Eman Sayed</last_name>
    <phone>01004082014</phone>
    <email>eshh2003@yahoo.com</email>
  </overall_contact_backup>
  <reference>
    <citation>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.</citation>
    <PMID>15257662</PMID>
  </reference>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>July 21, 2019</last_update_submitted>
  <last_update_submitted_qc>July 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mylove Amira</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autistic Disorder</mesh_term>
    <mesh_term>Autism Spectrum Disorder</mesh_term>
    <mesh_term>Child Development Disorders, Pervasive</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03267095
org study id: MTH ASD
nct id: NCT03267095
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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 .
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
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The Arabic Language test
time frame: Baseline,Change from Baseline at the end of 12 Months Music Therapy .
description: 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
arm group label: Study
arm group type: Experimental
description: .Patient in stduy Arm will receive music therapy sessions
arm group label: Control
arm group type: No Intervention
description: Patient in control Arm will have cosuling for mother and follow up
intervention type: Behavioral
intervention name: music therapy sessions .
description: 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.
arm group label: Study
criteria: 
gender: All
minimum age: 3 Years
maximum age: 7 Years
healthy volunteers: No
last name: EMAD KAML
phone: 01064228598
email: emad.ibrahim@med.au.edu.eg
last name: Eman Sayed
phone: 01004082014
email: eshh2003@yahoo.com
citation: 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.
PMID: 15257662
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Mylove Amira
investigator title: principal investigator
mesh term: Autistic Disorder
mesh term: Autism Spectrum Disorder
mesh term: Child Development Disorders, Pervasive