Reciprocal Imitation Training and Musical Rhythm Sensitivity in Autistic Toddlers

NCT ID: NCT05880225

Last Updated: 2025-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-03

Study Completion Date

2026-04-30

Brief Summary

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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

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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

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Autism Autism Spectrum Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Reciprocal Imitation Training

Intervention Type 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 (meRIT)

Children (n=20) receive 30 sessions of music-enhanced Reciprocal Imitation Training (meRIT), delivered in 40-60 minute sessions 2-3 times/week.

Group Type EXPERIMENTAL

music-enhanced Reciprocal Imitation Training

Intervention Type 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).

Interventions

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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.

Intervention Type BEHAVIORAL

music-enhanced Reciprocal Imitation Training

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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Months

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Miriam Lense

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Miriam Lense

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Warren Jones

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Miriam Lense

Role: CONTACT

615-322-3086

Facility Contacts

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Miriam Lense

Role: primary

Other Identifiers

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MH123029

Identifier Type: -

Identifier Source: org_study_id

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