Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03560297
Other study ID # 160784
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 15, 2018
Est. completion date March 20, 2020

Study information

Verified date February 2022
Source Vanderbilt University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date March 20, 2020
Est. primary completion date December 23, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Months to 72 Months
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
SeRenade Parent-Child Music Class
Parent-Child Music Class involving parent training, peer inclusion, and musical play
Delayed Intervention
Participants receive intervention after delay

Locations

Country Name City State
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (2)

Lead Sponsor Collaborator
Vanderbilt University Medical Center National Endowment for the Arts, United States

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other 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)
Other Program acceptability parent program evaluation survey post program (12 weeks)
Primary 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)
Primary Actions & Gestures Standardized parent report questionnaire of child's gestures/actions/pretend play Change from pre to post program (baseline and 12-weeks)
Primary Parenting Stress Index, 4th edition Short Form Standardized parent report questionnaire Change from pre to post program (baseline and 12-weeks)
Primary 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 Parent-Child Interaction parent-child play/music session Change from pre to post program (baseline and 12-weeks)
Secondary social visual attention eye-tracking paradigm Change from pre to post program (baseline and 12-weeks)
See also
  Status Clinical Trial Phase
Completed NCT05207956 - App for Strengthening Services In Specialized Therapeutic Support N/A
Completed NCT03286621 - Development of Eye-tracking Based Markers for Autism in Young Children
Completed NCT02608333 - Efficiency of Early Intervention for Autism Spectrum Disorder N/A
Recruiting NCT05935722 - Evaluation of a Home-based Parenting Support Program: Parenting Young Children N/A
Active, not recruiting NCT06259539 - A YouTube Curriculum for Children With Autism and Obesity N/A
Active, not recruiting NCT06303791 - Digital-based Psychosocial Intervention for Parents of Children With Neurodevelopmental Disorders N/A
Enrolling by invitation NCT05017779 - A Hybrid Effectiveness-implementation Trial of a High School-based Executive Function Treatment for Autistic Youth N/A
Completed NCT04772898 - Effectiveness of a 6-week Hippotherapy Program in Children With Autism Spectrum Disorder N/A
Recruiting NCT04987541 - The Therapeutic Effect of TBS Stimulation on Emotion Regulation in Autism Spectrum Disorder N/A
Completed NCT04308915 - Mobile-based Games for Cognitive Training in Children With Neurodevelopmental Disorders N/A
Completed NCT06038435 - The Effect of Cognitive Orientation Approach on Daily Occupational Performance With Autism Spectrum Disorder N/A
Terminated NCT04049981 - Investigation of Mechanisms of Action in Superpower Glass Phase 1/Phase 2
Completed NCT03693313 - The Effect of CrossFit Kids on Social Skills in Children With Autism Spectrum Disorder (CrossFit KAMP) N/A
Recruiting NCT04107064 - Achieving Steady Work Among Adults With Autism Through Specialized Employment Program N/A
Recruiting NCT03812068 - Parent-mediated Developmental Behavioral Intervention N/A
Completed NCT03206996 - Exposure Therapy for Auditory Sensitivity in Autism N/A
Completed NCT02299700 - Study to Evaluate the Janssen Autism Knowledge Engine in Children and Adults With Autism Spectrum Disorder N/A
Completed NCT03422016 - Electroretinogram in Autistic Spectrum Disorders
Active, not recruiting NCT03548779 - North Carolina Genomic Evaluation by Next-generation Exome Sequencing, 2 N/A
Recruiting NCT05114538 - Improving the Part C Early Intervention Service Delivery System for Children With ASD N/A