NCT03560297

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2018

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 18, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2020

Completed
Last Updated

February 8, 2022

Status Verified

February 1, 2022

Enrollment Period

1.6 years

First QC Date

May 21, 2018

Last Update Submit

February 5, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

  • Parent-Child Interaction

    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 Outcomes (2)

  • parent mood/connection

    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

    post program (12 weeks)

Study Arms (2)

SeRenade Program

EXPERIMENTAL

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

Behavioral: SeRenade Parent-Child Music Class

Delayed/Waitlist Program

EXPERIMENTAL

Participants do not participate in the program for a time period

Behavioral: Delayed Intervention

Interventions

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

SeRenade Program

Participants receive intervention after delay

Delayed/Waitlist Program

Eligibility Criteria

Age20 Months - 72 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • children diagnosed with ASD or children without ASD

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Instructor

Study Record Dates

First Submitted

May 21, 2018

First Posted

June 18, 2018

Study Start

May 15, 2018

Primary Completion

December 23, 2019

Study Completion

March 20, 2020

Last Updated

February 8, 2022

Record last verified: 2022-02

Locations