NCT06424366

Brief Summary

This study will be a randomized trial that will examine the impact of a recreational ballet program on children with autism spectrum disorder (ASD). The research team are primarily interested in assessing changes in motor skills with secondary objectives focused on the social, psychological, and behavioral effects. The study will aim to collect data from 24 participants with ASD. Participants must be 7-12 years old, have a confirmed diagnosis of ASD, and speak English or Spanish. All participants will be enrolled in a 12 week ballet program. The ballet program is based off the curriculum and structure of Ballet for All Kids, a non-profit organization that has been tailoring ballet classes for children with ASD for over one decade. All research team members and volunteers will be trained in the BFAK program's curriculum and structure. Ballet instruction and all research materials will be provided in both English and Spanish. The research team will randomize the sample into an intervention group and waitlist control. The research team will measure outcomes through validated self-reports that caregivers will complete. For the intervention group, questionnaires will be completed at baseline and throughout the intervention (weeks 4, 8, and 12). For those in the waitlist control group, questionnaires will be completed at baseline, throughout the intervention group's ballet classes, and throughout their own participation in the program. Results of this study will help to determine if how a recreational ballet program can impact the motor, psychological, social, and behavioral skills of a child with ASD, informing the direction of future research and interventions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 22, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

July 17, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
Last Updated

April 16, 2025

Status Verified

April 1, 2025

Enrollment Period

9 months

First QC Date

May 16, 2024

Last Update Submit

April 11, 2025

Conditions

Keywords

BalletAutismMotorRecreationalChildrenDance

Outcome Measures

Primary Outcomes (1)

  • Development Coordination Disorder Questionnaire

    Development Coordination Disorder Questionnaire will be completed by caregivers and will assess participants' motor skills throughout the study. Minimum score= 15. Maximum score= 75. A higher score indicates more advanced motor skills.

    at baseline and weeks 4, 8, and 12

Secondary Outcomes (5)

  • Aberrant Behavior Checklist

    at baseline and weeks 4, 8, and 12

  • Social Responsiveness Scale 2

    at baseline and weeks 4, 8, and 12

  • Children's Sleep Habits Questionnaire (Abbreviated)

    at baseline and weeks 4, 8, and 12

  • The Repetitive Behavior Scale

    at baseline and weeks 4, 8, and 12

  • Caregiver Strain Questionnaire

    at baseline and weeks 4, 8, and 12

Study Arms (2)

Immediate Ballet Program

EXPERIMENTAL

12 weeks of ballet classes immediately after recruitment and randomization concludes.

Behavioral: Ballet for All Kids

Deferred Ballet Program

PLACEBO COMPARATOR

12 weeks of ballet classes after the first arm completes the intervention. Participants in this arm will continue to complete self-reports while they wait to begin the intervention.

Behavioral: Ballet for All Kids

Interventions

The intervention consists of 12 weeks of ballet classes that follow the structure and curriculum of Ballet for All Kids (BFAK). BFAK is a non-profit organization that has been tailoring ballet classes for children with autism spectrum disorder for over one decade. Ballet classes will be held once a week for 45 minute sessions and led by trained medical and graduate students who have successfully completed BFAK's training and certification. BFAK instruction is based on the Schlachte Method, which combines auditory, visual, vestibular, and emotional learning to individualize instruction to match each child's skill level. In classroom accommodations include, but are not limited to a visual schedule, personal dance areas demarcated by tape on the floor, and one-on-one volunteer assistance.

Deferred Ballet ProgramImmediate Ballet Program

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Confirmed diagnosis of autism spectrum disorder
  • Fluent in English or Spanish
  • Between 7-12 years old

You may not qualify if:

  • For any reason the individual appears unable to participate in study procedures per the Principal Investigator
  • Not fluent in English or Spanish
  • Unable to commit to at least 8 of the 12 scheduled intervention sessions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Alexander Kolevzon, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Due to the nature of the intervention (ballet classes) and that caregivers will be completing all questionnaires, masking is not possible.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study will use a waitlist control design. The first arm will be the experimental arm and will immediately begin the intervention post recruitment. The second arm will be the waitlist control arm and will begin the intervention after the first arm's completion.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 16, 2024

First Posted

May 22, 2024

Study Start

July 17, 2024

Primary Completion

March 30, 2025

Study Completion

March 30, 2025

Last Updated

April 16, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Due to the small sample size, recruitment of minor populations, and sensitive nature of some of the questionnaires, we will not be sharing IPD.

Locations