An interventional study of Reciprocal Imitation Training and music-enhanced Reciprocal Imitation Training in Autism and Autism Spectrum Disorder, sponsored by Vanderbilt University Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Months to 36 Months. Per ClinicalTrials.gov, last updated 2026-05-20.
Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Treatment
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.
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.
1,030 studies on the registry are indexed under Autistic Disorder; 266 are open to participants now.
This study's planned enrollment of 40 is below the median of 49 across 811 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →Vanderbilt University Medical Center is the lead sponsor of 833 studies on the registry; 155 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 92 (74%) have results posted.
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Exclusion Criteria:
Children (n=20) receive 30 sessions of Reciprocal Imitation Training (RIT), delivered in 40-60 minute sessions 2-3 times/week.
Behavioral: Reciprocal Imitation Training
Children (n=20) receive 30 sessions of music-enhanced Reciprocal Imitation Training (meRIT), delivered in 40-60 minute sessions 2-3 times/week.
Behavioral: music-enhanced Reciprocal Imitation Training
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 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).
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.
Time frame: Change from baseline through 2-week follow-up post-intervention
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.
Time frame: 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.
Time frame: 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)
Time frame: Change from baseline to 2-weeks follow-up after intervention
Started Jul 2023 (actual). Primary completion is estimated for Apr 2027, 45 months after the start.
Of 354 non-industry interventional studies with no phase under Autistic Disorder, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 52. This study's planned 45 months is above that.
Counting every sponsor, half of 366 studies reached it within 26 months; a quarter within 13 and three quarters within 52.
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