Autism Spectrum DisorderASDNCT06295705
Exploring the Effectiveness of Dance as an Intervention to Promote Social-Emotional Health in Children With Autism Spectrum Disorder (ASD)
A study testing Hip-Hop Dance in people with Autism Spectrum Disorder, run by Loma Linda University at 1 site in United States.
Trial summary
This study will explore the effectiveness of dance as an intervention to promote social-emotional health within children with ASD. Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Hip-Hop Dance
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2024to 25 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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):
Show all 10Show fewer
- 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.
Who cannot join
- No IEP Primary Eligibility of Autism.
- No children participants younger than 7.
- No children participants older than 11.
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Health
Loma Linda, California, 92350
About this study
Official title: 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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Hip-Hop Dance
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip-Hop DanceBehavioural
- Week 1 - Session 1
- Daily Check-In
- Warm-Up: Mobility/Grooves
- Lesson: Style - Hip-Hop
- Cool-Down: Deep Breathing
- Debrief Check-In
II. Week 2 - Session 2
- Daily Check-In
- Warm-Up: Mobility/Grooves
- Lesson: Style - Locking
- Cool-Down: Instructed Yoga
- Debrief Check-In
III. Week 3 - Session 3
- Daily Check-In
- Warm-Up: Mobility/Grooves
- Lesson: Style - Breaking
- Cool-Down: Sensory Time
- Debrief Check-In
IV. Week 4 - Session 4
- Daily Check-In
- Warm-Up: Mobility/Grooves
- Lesson: Style - Popping
- Cool-Down: Animal Deep Breathing
- Debrief Check-In
- Week 5 - Session 5
- Daily Check-In
- Warm-Up: Mobility/Grooves
- Lesson: Learn Showcase Routine
- Cool-Down: Animal Instructed Yoga
- Debrief Check-In
VI. Week 6 - Session 6
- Daily Check-In
- Warm-Up: Mobility/Grooves
- Lesson: Review Showcase Routine
- Cool-Down: Sensory Time
- Debrief Check-In
VII. Week 7 - Dance Showcase
| Study group | Role | What they receive |
|---|---|---|
| Hip-Hop Dance | Experimental | 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. Receives: Behavioral: Hip-Hop Dance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Description of Impact on Social-Emotional Health
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.
Measured: Change between baseline (time of enrollment) and Week 7
Secondary outcomes (2)
Parent Perspective of Impact on Social-Emotional Health
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.
Measured: Change between baseline (time of enrollment) and Week 7 (program completion)
Change in Social-Emotional Behavior
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.
Measured: Change between baseline (time of enrollment) and Week 7 (program completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start2 Apr 2024
- Primary completion25 May 2024
- Study completion25 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06295705
- Sponsor's protocol ID
- 5230588
- Acronym
- ASD
- Status last verified
- May 2025
- First submitted
- 28 Feb 2024
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effectiveness of Dance as an Intervention to Promote Social-Emotional Health Within the Everyday Lives of Children With ASD
- ClinicalTrials.gov ID
- NCT06295705
- Acronym / sponsor ID
- ASD / 5230588
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 25 May 2024 (actual)
- Study completion
- 25 May 2024 (actual)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will explore the effectiveness of dance as an intervention to promote social-emotional health within children with ASD.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hip-Hop Dance | Experimental | Behavioral: Hip-Hop DanceThe 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. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (3 listed)
- No IEP Primary Eligibility of Autism.
- No children participants younger than 7.
- No children participants older than 11.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hip-Hop DanceI. 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 | Behavioural | Hip-Hop Dance |
Primary outcome
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.
2 secondary outcomes
Parent Perspective of Impact on Social-Emotional Health
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Individual participant dataSharing planned: No
Related trials for Autism Spectrum Disorder
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hip-Hop Dance in people with Autism Spectrum Disorder, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Description of Impact on Social-Emotional Health (time frame: Change between baseline (time of enrollment) and Week 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.