SeRenade Parent-Child Music Class Program

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

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.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Behavioral: SeRenade Parent-Child Music Class; Behavioral: Delayed Intervention

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 6 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor Imitation Scale	Standardized elicited imitation assessment; scores range 0-32; greater scores indicate greater imitation skills	Change from pre to post program (baseline and 12-weeks)
Actions & Gestures	Standardized parent report questionnaire of child's gestures/actions/pretend play	Change from pre to post program (baseline and 12-weeks)
Parenting Stress Index, 4th edition Short Form	Standardized parent report questionnaire	Change from pre to post program (baseline and 12-weeks)
Parenting Efficacy/Quality	Parent report questionnaire; higher scores indicate greater efficacy, range 10-40	Change from pre to post program (baseline and 12-weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parent-Child Interaction	parent-child play/music session	Change from pre to post program (baseline and 12-weeks)
social visual attention eye-tracking paradigm		Change from pre to post program (baseline and 12-weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
parent mood/connection	parent ratings	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)
Program acceptability	parent program evaluation survey	post program (12 weeks)

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: National Endowment for the Arts, United States

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 15, 2018
• Primary Completion (ACTUAL): December 23, 2019
• Study Completion (ACTUAL): March 20, 2020

Study Registration Dates

• First Submitted: May 21, 2018
• First Submitted That Met QC Criteria: June 15, 2018
• First Posted (ACTUAL): June 18, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2022
• Last Update Submitted That Met QC Criteria: February 5, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Anticonvulsants; Nitrazepam
• Other Study ID Numbers: 160784

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Deidentified data and codebooks will be available to researchers upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No