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SeRenade Parent-Child Music Class Program

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ClinicalTrials.gov Identifier: NCT03560297
Recruitment Status : Completed
First Posted : June 18, 2018
Last Update Posted : February 8, 2022
Sponsor:
Collaborator:
National Endowment for the Arts, United States
Information provided by (Responsible Party):
Miriam Lense, Vanderbilt University Medical Center

Study Description
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Brief Summary:
This pilot study examines the impact of the SeRenade Parent-Child Music Class Program, which emphasizes parent training, peer inclusion, and musical play combined with established behavioral techniques, on the development of child social engagement, positive behavior, and parental well-being.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: SeRenade Parent-Child Music Class Behavioral: Delayed Intervention Not Applicable

Detailed Description:
This pilot study evaluates the impact of the SeRenade Parent-Child Music Class Program on families of children with and without autism spectrum disorders (ASD). This study examines the impact of this program on social development in children with ASD, parental stress and efficacy, and parent-child relationships. A primary goal of this study is to examine multiple levels of analysis including families' experience within and outside of the music class program.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: SeRenade Parent-Child Music Class Program for Families of Children With and Without ASD
Actual Study Start Date : May 15, 2018
Actual Primary Completion Date : December 23, 2019
Actual Study Completion Date : March 20, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: SeRenade Program
Parent-Child Music Class Program (parent training, peer inclusion, musical play)
 Behavioral: SeRenade Parent-Child Music Class
Parent-Child Music Class involving parent training, peer inclusion, and musical play
Experimental: Delayed/Waitlist Program
Participants do not participate in the program for a time period
 Behavioral: Delayed Intervention
Participants receive intervention after delay


Outcome Measures
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Primary Outcome Measures :
  1. Motor Imitation Scale [ Time Frame: Change from pre to post program (baseline and 12-weeks) ]
    Standardized elicited imitation assessment; scores range 0-32; greater scores indicate greater imitation skills

  2. Actions & Gestures [ Time Frame: Change from pre to post program (baseline and 12-weeks) ]
    Standardized parent report questionnaire of child's gestures/actions/pretend play

  3. Parenting Stress Index, 4th edition Short Form [ Time Frame: Change from pre to post program (baseline and 12-weeks) ]
    Standardized parent report questionnaire

  4. Parenting Efficacy/Quality [ Time Frame: Change from pre to post program (baseline and 12-weeks) ]
    Parent report questionnaire; higher scores indicate greater efficacy, range 10-40


Secondary Outcome Measures :
  1. Parent-Child Interaction [ Time Frame: Change from pre to post program (baseline and 12-weeks) ]
    parent-child play/music session

  2. social visual attention eye-tracking paradigm [ Time Frame: Change from pre to post program (baseline and 12-weeks) ]

Other Outcome Measures:
  1. parent mood/connection [ Time Frame: change from before/after the class session at class 1 (week 1) to 12 (week 12) (a session of classes is 12-weeks on average) ]
    parent ratings

  2. Program acceptability [ Time Frame: post program (12 weeks) ]
    parent program evaluation survey


Eligibility Criteria
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Ages Eligible for Study:   20 Months to 72 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • children diagnosed with ASD or children without ASD

Exclusion Criteria:

  • currently enrolled in music therapy or parent-child music classes (for children with ASD); significant behavior problems (e.g., aggression toward other children); significant hearing or visual impairments
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03560297


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
National Endowment for the Arts, United States
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Miriam Lense, Research Instructor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03560297    
Other Study ID Numbers: 160784
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: February 8, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Deidentified data and codebooks will be available to researchers upon request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Nitrazepam
Anticonvulsants
Hypnotics and Sedatives
Central Nervous System Depressants
 Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action