- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05880225
Reciprocal Imitation Training and Musical Rhythm Sensitivity in Autistic Toddlers
May 18, 2026 updated by: Miriam Lense, Vanderbilt University Medical Center
Musical Rhythm Sensitivity to Scaffold Social Engagement in Autism Spectrum Disorder
The primary goal of this study is to examine rhythm sensitivity as a predictor of response to naturalistic developmental behavioral intervention (NDBIs) in autistic toddlers.
Toddlers receive either Reciprocal Imitation Training (RIT), an evidence-based NDBI that supports children's imitation and social communication skills, or a music-enhanced version of RIT.
Throughout their participation in the intervention, toddlers will complete study procedures of viewing naturalistic videos of infant-directed singing and other social scenes while eye gaze data is collected.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Social communication makes use of predictable, rhythmic behaviors and children are sensitive to the rhythm of social interaction from infancy.
The goal of the current study is to investigate if social rhythm sensitivity, measured via children' entrained eye-looking when viewing videos of infant-directed singing, predicts autistic toddlers' response to naturalistic developmental behavioral intervention (NDBI).
Following eligibility testing and baseline assessments, children are randomized to receive either 30 sessions of Reciprocal Imitation Training (RIT), an NDBI that uses evidence-based strategies to support children's imitation and social communication development, or a music-enhanced version of RIT that embeds music and rhythm within the RIT platform (meRIT).
Children's imitation skills are assessed before and after the intervention programs.
Children's rhythm sensitivity is assessed via repeated eye-tracking sessions throughout baseline, intervention, and two-weeks after the intervention ends.
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- 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
- Name: Miriam Lense
- Phone Number: 615-322-3086
- Email: miriam.lense@vumc.org
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37232
- Recruiting
- Vanderbilt University Medical Center
-
Contact:
- Miriam Lense
- Email: miriam.lense@vumc.org
-
-
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
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- diagnosis of autism / autism spectrum disorder
- 18-36 months of age
Exclusion Criteria:
- Major hearing or visual impairment (e.g., congenital nystagmus), seizure disorder, genetic syndromes, or gestational age <=34 weeks.
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Reciprocal Imitation Training (RIT)
Children (n=20) receive 30 sessions of Reciprocal Imitation Training (RIT), delivered in 40-60 minute sessions 2-3 times/week.
|
As a naturalistic developmental behavioral intervention (NDBI), Reciprocal Imitation Training (RIT) utilizes contingent imitation, linguistic mapping, modeling, prompting, and contingent reinforcement to train object and gesture imitation during play activities.
|
|
Experimental: Music-Enhanced Reciprocal Imitation Training (meRIT)
Children (n=20) receive 30 sessions of music-enhanced Reciprocal Imitation Training (meRIT), delivered in 40-60 minute sessions 2-3 times/week.
|
Music-enhanced imitation training uses music and rhythm to enhance the predictability and salience of the strategies utilized within the Reciprocal Imitation Training platform (i.e., contingent imitation, linguistic mapping, modeling, prompting, and contingent reinforcement to train object and gesture imitation during play activities).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in rhythmically entrained eye-looking (eye-tracking)
Time Frame: Change from baseline through 2-week follow-up post-intervention
|
Trajectories of rhythmically entrained eye-looking to predictable and unpredictable child-directed singing assessed via passive eye-tracking.
|
Change from baseline through 2-week follow-up post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in overall fixation to eyes (eye-tracking)
Time Frame: Change from baseline through 2-week follow-up post-intervention
|
Trajectories of proportion of time spent fixating on the eyes while viewing predictable and unpredictable child-directed singing assessed via passive eye-tracking.
|
Change from baseline through 2-week follow-up post-intervention
|
|
Change in child elicited motor imitation
Time Frame: Change from baseline to 2-weeks follow-up after intervention
|
Children's performance on the Motor Imitation Scale (score 0-32).
Higher scores indicate greater performance.
|
Change from baseline to 2-weeks follow-up after intervention
|
|
Change in child spontaneous motor imitation
Time Frame: Change from baseline to 2-weeks follow-up after intervention
|
Children's performance on the Unstructured Imitation Assessments (score 0-20)
|
Change from baseline to 2-weeks follow-up after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Miriam Lense, Vanderbilt University Medical Center
- Principal Investigator: Warren Jones, Emory 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)
July 3, 2023
Primary Completion (Estimated)
April 30, 2027
Study Completion (Estimated)
April 30, 2027
Study Registration Dates
First Submitted
May 10, 2023
First Submitted That Met QC Criteria
May 18, 2023
First Posted (Actual)
May 30, 2023
Study Record Updates
Last Update Posted (Actual)
May 20, 2026
Last Update Submitted That Met QC Criteria
May 18, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MH123029
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.