## Protocol Section
### Identification Module
**NCT ID:** NCT06424366

**Acronym:** ADAPT

**Brief Title:** Approach to Dance for Autism

**Official Title:** ADAPT: Approach to Dance for Autism

#### Organization Study ID Info
**ID:** STUDY-24-00144
#### Organization
**Class:** OTHER
**Full Name:** Icahn School of Medicine at Mount Sinai
### Status Module
#### Completion Date
**Date:** 2025-03-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-03-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-08-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Icahn School of Medicine at Mount Sinai

#### Responsible Party

**Investigator Affiliation:** Icahn School of Medicine at Mount Sinai

**Investigator Full Name:** Alexander Kolevzon

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Autism Spectrum Disorder

**Keywords:**

- Ballet

- Autism

- Motor

- Recreational

- Children

- Dance

### Design Module

#### Design Info

**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.

##### Masking Info

**Masking:** NONE

**Masking Description:** Due to the nature of the intervention (ballet classes) and that caregivers will be completing all questionnaires, masking is not possible.

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 24

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Behavioral: Ballet for All Kids

**Label:** Immediate Ballet Program

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Behavioral: Ballet for All Kids

**Label:** Deferred Ballet Program

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Deferred Ballet Program

- Immediate Ballet Program

**Description:** 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.

**Name:** Ballet for All Kids

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Development Coordination Disorder Questionnaire

**Time Frame:** at baseline and weeks 4, 8, and 12

#### Secondary Outcomes

**Description:** 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).

**Measure:** Aberrant Behavior Checklist

**Time Frame:** at baseline and weeks 4, 8, and 12

**Description:** 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.

**Measure:** Social Responsiveness Scale 2

**Time Frame:** at baseline and weeks 4, 8, and 12

**Description:** 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.

**Measure:** Children's Sleep Habits Questionnaire (Abbreviated)

**Time Frame:** at baseline and weeks 4, 8, and 12

**Description:** 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.

**Measure:** The Repetitive Behavior Scale

**Time Frame:** at baseline and weeks 4, 8, and 12

**Description:** 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.

**Measure:** Caregiver Strain Questionnaire

**Time Frame:** at baseline and weeks 4, 8, and 12

### Eligibility Module

**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

**Maximum Age:** 12 Years

**Minimum Age:** 7 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** noy.alon@icahn.mssm.edu

**Name:** Noy Alon

**Phone:** 212-241-0961

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** New York

**Contacts:**

***Contact 1:***

- **Email:** alexander.kolevzon@mssm.edu

- **Name:** Alexander Kolevzon, MD

- **Phone:** 212-659-8752

- **Role:** CONTACT

***Contact 2:***

- **Name:** Alexander Kolevzon

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Icahn School of Medicine at Mount Sinai

**State:** New York

**Zip:** 10029

#### Overall Officials

**Official 1:**

**Affiliation:** Icahn School of Medicine at Mount Sinai

**Name:** Alexander Kolevzon, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**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.

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002659

- Term: Child Development Disorders, Pervasive

- ID: D000065886

- Term: Neurodevelopmental Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4623

- Name: Autistic Disorder

- Relevance: HIGH

- As Found: Autism

- ID: M206

- Name: Autism Spectrum Disorder

- Relevance: HIGH

- As Found: Autism Spectrum Disorder

- ID: M5903

- Name: Child Development Disorders, Pervasive

- Relevance: LOW

- As Found: Unknown

- ID: M5902

- Name: Developmental Disabilities

- Relevance: LOW

- As Found: Unknown

- ID: M30644

- Name: Neurodevelopmental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001321

- Term: Autistic Disorder

- ID: D000067877

- Term: Autism Spectrum Disorder

### Misc Info Module

- Version Holder: 2024-05-31
