Autism Spectrum Disorder Clinical Trial
Official title:
SeRenade Parent-Child Music Class Program for Families of Children With and Without ASD
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 |
Verified date | February 2022 |
Source | Vanderbilt University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University Medical Center | National Endowment for the Arts, United States |
United States,
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) |
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