AutismNCT05880225
Reciprocal Imitation Training and Musical Rhythm Sensitivity in Autistic Toddlers
A study testing Reciprocal Imitation Training and music-enhanced Reciprocal Imitation Training in people with Autism and Autism Spectrum Disorder, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 36 months
- Conditions the study is for
- Autism, Autism Spectrum Disorder
- What is being tested?
- Reciprocal Imitation Training and music-enhanced Reciprocal Imitation Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2023to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- diagnosis of autism / autism spectrum disorder
- 18-36 months of age
Who cannot join
- Major hearing or visual impairment (e.g., congenital nystagmus), seizure disorder, genetic syndromes, or gestational age <=34 weeks.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Miriam Lense, miriam.lense@vumc.org
About this study
Official title: 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.
Read the 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.
- Conditions
- Autism, Autism Spectrum Disorder
- Being tested
- Reciprocal Imitation Training, music-enhanced Reciprocal Imitation Training
- Keywords
- autism, imitation, social communication, rhythm, music
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reciprocal Imitation TrainingBehavioural
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.
music-enhanced Reciprocal Imitation TrainingBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Reciprocal Imitation Training (RIT) | Active comparator | Children (n=20) receive 30 sessions of Reciprocal Imitation Training (RIT), delivered in 40-60 minute sessions 2-3 times/week. Receives: Behavioral: Reciprocal Imitation Training |
| Music-Enhanced Reciprocal Imitation Training (meRIT) | Experimental | Children (n=20) receive 30 sessions of music-enhanced Reciprocal Imitation Training (meRIT), delivered in 40-60 minute sessions 2-3 times/week. Receives: Behavioral: music-enhanced Reciprocal Imitation Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in rhythmically entrained eye-looking (eye-tracking)
Trajectories of rhythmically entrained eye-looking to predictable and unpredictable child-directed singing assessed via passive eye-tracking.
Measured: Change from baseline through 2-week follow-up post-intervention
Secondary outcomes (3)
Change in overall fixation to eyes (eye-tracking)
Trajectories of proportion of time spent fixating on the eyes while viewing predictable and unpredictable child-directed singing assessed via passive eye-tracking.
Measured: Change from baseline through 2-week follow-up post-intervention
Change in child elicited motor imitation
Children's performance on the Motor Imitation Scale (score 0-32). Higher scores indicate greater performance.
Measured: Change from baseline to 2-weeks follow-up after intervention
Change in child spontaneous motor imitation
Children's performance on the Unstructured Imitation Assessments (score 0-20)
Measured: Change from baseline to 2-weeks follow-up after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start3 Jul 2023
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Miriam Lense, Vanderbilt University Medical Center
- Investigators
- Miriam Lense, Principal investigator, Vanderbilt University Medical CenterWarren Jones, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05880225
- Sponsor's protocol ID
- MH123029
- Status last verified
- May 2026
- First submitted
- 10 May 2023
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Musical Rhythm Sensitivity to Scaffold Social Engagement in Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT05880225
- Acronym / sponsor ID
- MH123029
- Conditions
- Autism, Autism Spectrum Disorder
- Keywords
- autism, imitation, social communication, rhythm, music
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 30 May 2023 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reciprocal Imitation Training (RIT) | Active comparator | Behavioral: Reciprocal Imitation TrainingChildren (n=20) receive 30 sessions of Reciprocal Imitation Training (RIT), delivered in 40-60 minute sessions 2-3 times/week. |
| Music-Enhanced Reciprocal Imitation Training (meRIT) | Experimental | Behavioral: music-enhanced Reciprocal Imitation TrainingChildren (n=20) receive 30 sessions of music-enhanced Reciprocal Imitation Training (meRIT), delivered in 40-60 minute sessions 2-3 times/week. |
Who may qualify
- Ages
- 18 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- diagnosis of autism / autism spectrum disorder
- 18-36 months of age
Key exclusion criteria (1 listed)
- Major hearing or visual impairment (e.g., congenital nystagmus), seizure disorder, genetic syndromes, or gestational age <=34 weeks.
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 |
|---|---|---|
| Reciprocal Imitation TrainingAs 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. | Behavioural | Reciprocal Imitation Training (RIT) |
| music-enhanced Reciprocal Imitation TrainingMusic-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). | Behavioural | Music-Enhanced Reciprocal Imitation Training (meRIT) |
Primary outcome
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.
3 secondary outcomes
Change in overall fixation to eyes (eye-tracking)
Time frame: 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
Change in child spontaneous motor imitation
Time frame: Change from baseline to 2-weeks follow-up after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
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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.
Miriam Lense principal investigator
Vanderbilt University Medical Center
Warren Jones principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reciprocal Imitation Training and music-enhanced Reciprocal Imitation Training in people with Autism and Autism Spectrum Disorder, run by Vanderbilt University Medical Center 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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 20 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miriam Lense (615-322-3086, miriam.lense@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in rhythmically entrained eye-looking (eye-tracking) (time frame: Change from baseline through 2-week follow-up post-intervention). 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 20 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.