- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06424366
Approach to Dance for Autism (ADAPT)
April 11, 2025 updated by: Alexander Kolevzon, Icahn School of Medicine at Mount Sinai
ADAPT: Approach to Dance for Autism
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10029
- Icahn School of Medicine at Mount Sinai
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Confirmed diagnosis of autism spectrum disorder
- Fluent in English or Spanish
- Between 7-12 years old
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Immediate Ballet Program
12 weeks of ballet classes immediately after recruitment and randomization concludes.
|
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.
|
|
Placebo Comparator: Deferred Ballet Program
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Development Coordination Disorder Questionnaire
Time Frame: at baseline and weeks 4, 8, and 12
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Aberrant Behavior Checklist
Time Frame: at baseline and weeks 4, 8, and 12
|
The Aberrant Behavior Checklist will be completed by caregivers and will assess participants' behaviors such as irritability; lethargy; stereotypy; hyperactivity; and inappropriate speech.
Minimum score= 0. Maximum score= 174.
A higher score indicates a greater degree of that behavior (i.e. higher scores on irritability would indicate that child tends to be more irritable).
|
at baseline and weeks 4, 8, and 12
|
|
Social Responsiveness Scale 2
Time Frame: at baseline and weeks 4, 8, and 12
|
The Social Responsiveness Scale 2 will be completed by caregivers and will assess participants' social behaviors throughout the study.
Minimum raw score = 65.
Maximum raw score = 260.
T-scores have a mean of 50 and a SD of 10.
Raw scores are converted to T scores based on the child's gender.
A higher score indicates more severe social impairments.
|
at baseline and weeks 4, 8, and 12
|
|
Children's Sleep Habits Questionnaire (Abbreviated)
Time Frame: at baseline and weeks 4, 8, and 12
|
The Children's Sleep Habits Questionnaire will be completed by caregivers and will assess participants' sleep throughout the study.
Minimum score = 0. Maximum score = 154.
A higher score indicates more sleep disturbances.
|
at baseline and weeks 4, 8, and 12
|
|
The Repetitive Behavior Scale
Time Frame: at baseline and weeks 4, 8, and 12
|
The Repetitive Behavior Scale will be completed by caregivers and will assess participants' repetitive behaviors and restricted interests throughout the study.
Minimum score = 0. Maximum score = 129.
A higher score indicates more severe behaviors.
|
at baseline and weeks 4, 8, and 12
|
|
Caregiver Strain Questionnaire
Time Frame: at baseline and weeks 4, 8, and 12
|
The Caregiver Strain Questionnaire will be completed by caregivers and will assess caregivers' stress related to parental/familial responsibilities throughout the study.
Minimum score = 21.
Maximum score = 105.
A higher score indicates that a caregiver experiences more distress due to their familial responsibilities.
|
at baseline and weeks 4, 8, and 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Alexander Kolevzon, MD, Icahn School of Medicine at Mount Sinai
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 17, 2024
Primary Completion (Actual)
March 30, 2025
Study Completion (Actual)
March 30, 2025
Study Registration Dates
First Submitted
May 16, 2024
First Submitted That Met QC Criteria
May 16, 2024
First Posted (Actual)
May 22, 2024
Study Record Updates
Last Update Posted (Actual)
April 16, 2025
Last Update Submitted That Met QC Criteria
April 11, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY-24-00144
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Due to the small sample size, recruitment of minor populations, and sensitive nature of some of the questionnaires, we will not be sharing IPD.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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