Exploring the Effectiveness of Dance as an Intervention to Promote Social-Emotional Health in Children With Autism Spectrum Disorder (ASD) (ASD)

May 6, 2025 updated by: Loma Linda University

Exploring the Effectiveness of Dance as an Intervention to Promote Social-Emotional Health Within the Everyday Lives of Children With ASD

This study will explore the effectiveness of dance as an intervention to promote social-emotional health within children with ASD.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study will look children with ASD's response to a 7-week occupational therapy led dance program in regards to social-emotional health. This will include exploring the effect on change of social-emotional behavior in children with ASD after being exposed to dance intervention through comparing the quantitative measurements of pre- and post-assessment scores of the Developmental Profile 4 (DP-4), analysis of the qualitative measurements of pre- and post-social-emotional behaviors via child report, and analysis of qualitative observations of social-emotional behavior through reviewing video recording of dance classes. Additionally, parents' perspectives will be explored through post-interview questions to share their observations of their child's experience.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Julie Kugel, OTD
  • Phone Number: (909) 558-4628
  • Email: jkugel@llu.edu

Study Contact Backup

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92350
        • Loma Linda University Health

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria for Youth Participants

  • Elementary school children ages 7-11.

  • Parent/caregiver/guardian must provide proof of an Individualized Education Plan (IEP) with a Primary Eligibility of Autism.

    o Parent/caregiver/guardian must provide proof of IEP and eligibility.

  • Will speak and understand English.
  • Able to physically participate in the dance program without the use of adaptive equipment.

  • Answer yes to the following Skillset Checklist (Per parent/caregiver/guardian report):

    • Follow 1- and 2-step instructions.
    • Follow structured activities with supervision (e.g., visual schedule, routine).
    • Previous participation in extracurricular group activities over the last 6 months - 1 year (e.g., structured sports).
    • Minimum 5-minutes of attention to task.

Exclusion Criteria:

  • No IEP Primary Eligibility of Autism.
  • No children participants younger than 7.
  • No children participants older than 11.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Hip-Hop Dance
The program will be a 7-week occupational therapy led dance program utilizing hip-hop dance as an intervention. Subjects with ASD will dance for 1 time a week for 60 minutes, ending with a dance showcase on the final week.
Behavioral: Hip-Hop Dance

I. Week 1 - Session 1

  1. Daily Check-In
  2. Warm-Up: Mobility/Grooves
  3. Lesson: Style - Hip-Hop
  4. Cool-Down: Deep Breathing
  5. Debrief Check-In

II. Week 2 - Session 2

  1. Daily Check-In
  2. Warm-Up: Mobility/Grooves
  3. Lesson: Style - Locking
  4. Cool-Down: Instructed Yoga
  5. Debrief Check-In

III. Week 3 - Session 3

  1. Daily Check-In
  2. Warm-Up: Mobility/Grooves
  3. Lesson: Style - Breaking
  4. Cool-Down: Sensory Time
  5. Debrief Check-In

IV. Week 4 - Session 4

  1. Daily Check-In
  2. Warm-Up: Mobility/Grooves
  3. Lesson: Style - Popping
  4. Cool-Down: Animal Deep Breathing
  5. Debrief Check-In

V. Week 5 - Session 5

  1. Daily Check-In
  2. Warm-Up: Mobility/Grooves
  3. Lesson: Learn Showcase Routine
  4. Cool-Down: Animal Instructed Yoga
  5. Debrief Check-In

VI. Week 6 - Session 6

  1. Daily Check-In
  2. Warm-Up: Mobility/Grooves
  3. Lesson: Review Showcase Routine
  4. Cool-Down: Sensory Time
  5. Debrief Check-In

VII. Week 7 - Dance Showcase

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Child Description of Impact on Social-Emotional Health
Time Frame: Change between baseline (time of enrollment) and Week 7
Subject will be asked to describe emotional state immediately prior to weekly dance intervention and immediately after dance intervention completed. Subject will be asked to verbalize emotional state or choose an icon to represent emotional state. Interviewer will record subject response. Effectiveness will be measured based on verbal or visual responses between 3 options: "Happy", "Sad", or "Okay", where "Happy" is considered effective, "Sad" considered to be ineffective, or if the responses are the same before and after than there is no change. This is a composite measurement over the course of 7 weeks.
Change between baseline (time of enrollment) and Week 7

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Parent Perspective of Impact on Social-Emotional Health
Time Frame: Change between baseline (time of enrollment) and Week 7 (program completion)
Parent will complete the Developmental Profile 4 (DP-4) assessment pre- and post-program regarding the child's social-emotional behavior. Effectiveness will be measured on responses between "Yes" and "No", where "Yes" is applicable to the parent's child, and "No" is not applicable. This is a composite measurement with 1 domain and 36 sub questions of the assessment before and after the program.
Change between baseline (time of enrollment) and Week 7 (program completion)
Change in Social-Emotional Behavior
Time Frame: Change between baseline (time of enrollment) and Week 7 (program completion)
Subjects will be audio/video recorded in each dance class weekly. Researcher will observe and analyze recordings using a developed observation checklist of each subject. Effectiveness will be measured by responses of "Observed" and "Not Observed", where "Observed" is witness in the subject and is effective, and "Not Observed" is not witnessed in the subject and is ineffective.This is a composite measurement over the course of 7 weeks.
Change between baseline (time of enrollment) and Week 7 (program completion)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Loma Linda University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 2, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 25, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 25, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 5230588

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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