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SeRenade Parent-Child Music Class Program

Primary Purpose

Autism Spectrum Disorder

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

SeRenade Parent-Child Music Class

Delayed Intervention

About this trial

This is an interventional other trial for Autism Spectrum Disorder

Eligibility Criteria

20 Months - 72 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

SeRenade Program

Delayed/Waitlist Program

Arm Description

Parent-Child Music Class Program (parent training, peer inclusion, musical play)

Participants do not participate in the program for a time period

Outcomes

Primary Outcome Measures

Motor Imitation Scale

Standardized elicited imitation assessment; scores range 0-32; greater scores indicate greater imitation skills

Actions & Gestures

Standardized parent report questionnaire of child's gestures/actions/pretend play

Parenting Stress Index, 4th edition Short Form

Standardized parent report questionnaire

Parenting Efficacy/Quality

Parent report questionnaire; higher scores indicate greater efficacy, range 10-40

Secondary Outcome Measures

Parent-Child Interaction

parent-child play/music session

social visual attention eye-tracking paradigm

Full Information

NCT ID

NCT03560297

First Posted

May 21, 2018

Last Updated

February 5, 2022

Sponsor

Vanderbilt University Medical Center

Collaborators

National Endowment for the Arts, United States

1. Study Identification

Unique Protocol Identification Number

NCT03560297

Brief Title

SeRenade Parent-Child Music Class Program

Official Title

SeRenade Parent-Child Music Class Program for Families of Children With and Without ASD

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

May 15, 2018 (Actual)

Primary Completion Date

December 23, 2019 (Actual)

Study Completion Date

March 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Vanderbilt University Medical Center

Collaborators

National Endowment for the Arts, United States

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autism Spectrum Disorder

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SeRenade Program

Arm Type

Experimental

Arm Description

Parent-Child Music Class Program (parent training, peer inclusion, musical play)

Arm Title

Delayed/Waitlist Program

Arm Type

Experimental

Arm Description

Participants do not participate in the program for a time period

Intervention Type

Behavioral

Intervention Name(s)

SeRenade Parent-Child Music Class

Intervention Description

Parent-Child Music Class involving parent training, peer inclusion, and musical play

Intervention Type

Behavioral

Intervention Name(s)

Delayed Intervention

Intervention Description

Participants receive intervention after delay

Primary Outcome Measure Information:

Title

Motor Imitation Scale

Description

Standardized elicited imitation assessment; scores range 0-32; greater scores indicate greater imitation skills

Time Frame

Change from pre to post program (baseline and 12-weeks)

Title

Actions & Gestures

Description

Standardized parent report questionnaire of child's gestures/actions/pretend play

Time Frame

Change from pre to post program (baseline and 12-weeks)

Title

Parenting Stress Index, 4th edition Short Form

Description

Standardized parent report questionnaire

Time Frame

Change from pre to post program (baseline and 12-weeks)

Title

Parenting Efficacy/Quality

Description

Parent report questionnaire; higher scores indicate greater efficacy, range 10-40

Time Frame

Change from pre to post program (baseline and 12-weeks)

Secondary Outcome Measure Information:

Title

Parent-Child Interaction

Description

parent-child play/music session

Time Frame

Change from pre to post program (baseline and 12-weeks)

Title

social visual attention eye-tracking paradigm

Time Frame

Change from pre to post program (baseline and 12-weeks)

Other Pre-specified Outcome Measures:

Title

parent mood/connection

Description

parent ratings

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)

Title

Program acceptability

Description

parent program evaluation survey

Time Frame

post program (12 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Months

Maximum Age & Unit of Time

72 Months

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Vanderbilt University Medical Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

Deidentified data and codebooks will be available to researchers upon request.

Citations:

PubMed Identifier

35532041

Citation

Geretsegger 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.

Results Reference

derived

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SeRenade Parent-Child Music Class Program

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