Approach to Dance for Autism

Autism Spectrum Disorder Clinical Trial

— ADAPT  

Official title:

ADAPT: Approach to Dance for Autism

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06424366
• Other study ID #: STUDY-24-00144
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2024
• Est. completion date: March 31, 2025

Study information

• Verified date: June 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Noy Alon
• Phone: 212-241-0961
• Email: noy.alon[@]icahn.mssm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Behavioral:
• Ballet for All Kids
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.

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	at baseline and weeks 4, 8, and 12
Secondary	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.	at baseline and weeks 4, 8, and 12
Secondary	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.	at baseline and weeks 4, 8, and 12
Secondary	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.	at baseline and weeks 4, 8, and 12
Secondary	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.	at baseline and weeks 4, 8, and 12