Autism Spectrum DisorderADAPTNCT06424366
Approach to Dance for Autism
A study testing Ballet for All Kids in people with Autism Spectrum Disorder, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Ballet for All Kids
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2024to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Confirmed diagnosis of autism spectrum disorder
- Fluent in English or Spanish
- Between 7-12 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Ballet for All Kids
- Keywords
- Ballet, Autism, Motor, Recreational, Children, Dance
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ballet for All KidsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Ballet Program | Experimental | 12 weeks of ballet classes immediately after recruitment and randomization concludes. Receives: 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. Receives: Behavioral: Ballet for All Kids |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at baseline and weeks 4, 8, and 12
Secondary outcomes (5)
Aberrant Behavior Checklist
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).
Measured: at baseline and weeks 4, 8, and 12
Social Responsiveness Scale 2
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.
Measured: at baseline and weeks 4, 8, and 12
Children's Sleep Habits Questionnaire (Abbreviated)
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.
Measured: at baseline and weeks 4, 8, and 12
The Repetitive Behavior Scale
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.
Measured: at baseline and weeks 4, 8, and 12
Caregiver Strain Questionnaire
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.
Measured: at baseline and weeks 4, 8, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start17 Jul 2024
- Primary completion30 Mar 2025
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- American Psychiatric Association
- Responsible party
- Principal investigator, Alexander Kolevzon, Icahn School of Medicine at Mount Sinai
- Investigators
- Alexander Kolevzon, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06424366
- Sponsor's protocol ID
- STUDY-24-00144
- Acronym
- ADAPT
- Status last verified
- Apr 2025
- First submitted
- 16 May 2024
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the small sample size, recruitment of minor populations, and sensitive nature of some of the questionnaires, we will not be sharing IPD.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADAPT: Approach to Dance for Autism
- ClinicalTrials.gov ID
- NCT06424366
- Acronym / sponsor ID
- ADAPT / STUDY-24-00144
- Conditions
- Autism Spectrum Disorder
- Keywords
- Ballet, Autism, Motor, Recreational, Children, Dance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- American Psychiatric Association
- Study start
- 17 Jul 2024 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 22 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Immediate Ballet Program | Experimental | Behavioral: Ballet for All Kids12 weeks of ballet classes immediately after recruitment and randomization concludes. |
| Deferred Ballet Program | Placebo comparator | Behavioral: Ballet for All Kids12 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. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Confirmed diagnosis of autism spectrum disorder
- Fluent in English or Spanish
- Between 7-12 years old
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ballet for All KidsThe 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. | Behavioural | Deferred Ballet Program, Immediate Ballet Program |
Primary outcome
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.
5 secondary outcomes
Aberrant Behavior Checklist
Time frame: at baseline and weeks 4, 8, and 12
Social Responsiveness Scale 2
Time frame: 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 Repetitive Behavior Scale
Time frame: at baseline and weeks 4, 8, and 12
Caregiver Strain Questionnaire
Time frame: at baseline and weeks 4, 8, and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: No. Due to the small sample size, recruitment of minor populations, and sensitive nature of some of the questionnaires, we will not be sharing IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Kolevzon, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ballet for All Kids in people with Autism Spectrum Disorder, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development Coordination Disorder Questionnaire (time frame: at baseline and weeks 4, 8, and 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.