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NCT Number: NCT05880225

Reciprocal Imitation Training and Musical Rhythm Sensitivity in Autistic Toddlers

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.

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Key information

Conditions

Autism Autism Spectrum Disorder Autistic Disorder Behavior Child Development Disorders, Pervasive Communication Mental Disorders Neurodevelopmental Disorders

Age range

18 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location status: Recruiting

Location contact

Miriam Lense

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Reciprocal Imitation Training

Behavioral

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 Training

Behavioral

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Miriam Lense

CONTACT

[email protected]

615-322-3086

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)
  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Musical Rhythm Sensitivity to Scaffold Social Engagement in Autism Spectrum Disorder

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
May 30, 2023
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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