Clinical trial NCT06424366: Approach to Dance for Autism
Official title: ADAPT: Approach to Dance for Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Ballet
Autism
Motor
Recreational
Children
Dance
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: American Psychiatric Association
First posted: 2024-05-22
Enrollment: 24
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Development Coordination Disorder Questionnaire
timeFrame: at baseline and weeks 4, 8, and 12
Secondary outcomes:
measure: Aberrant Behavior Checklist
timeFrame: at baseline and weeks 4, 8, and 12
measure: Social Responsiveness Scale 2
timeFrame: at baseline and weeks 4, 8, and 12
measure: Children's Sleep Habits Questionnaire (Abbreviated)
timeFrame: at baseline and weeks 4, 8, and 12
measure: The Repetitive Behavior Scale
timeFrame: at baseline and weeks 4, 8, and 12
measure: Caregiver Strain Questionnaire
timeFrame: at baseline and weeks 4, 8, and 12
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Alexander Kolevzon, MD
role: PRINCIPAL_INVESTIGATOR
References: