- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06295705
Exploring the Effectiveness of Dance as an Intervention to Promote Social-Emotional Health in Children With Autism Spectrum Disorder (ASD) (ASD)
Exploring the Effectiveness of Dance as an Intervention to Promote Social-Emotional Health Within the Everyday Lives of Children With ASD
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Loma Linda, California, United States, 92350
- Loma Linda University Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
I. Week 1 - Session 1
II. Week 2 - Session 2
III. Week 3 - Session 3
IV. Week 4 - Session 4
V. Week 5 - Session 5
VI. Week 6 - Session 6
VII. Week 7 - Dance Showcase |
What is the study measuring?
Primary Outcome Measures
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5230588
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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