NCT05880225

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
12mo left

Started Jul 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress76%
Jul 2023Apr 2027

First Submitted

Initial submission to the registry

May 10, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 30, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

July 3, 2023

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

May 20, 2026

Status Verified

May 1, 2026

Enrollment Period

3.8 years

First QC Date

May 10, 2023

Last Update Submit

May 18, 2026

Conditions

AutismAutism Spectrum Disorder

Keywords

autismimitationsocial communicationrhythmmusic

Outcome Measures

Primary Outcomes (1)

  • 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.

    Change from baseline through 2-week follow-up post-intervention

Secondary Outcomes (3)

  • Change in overall fixation to eyes (eye-tracking)

    Change from baseline through 2-week follow-up post-intervention

  • Change in child elicited motor imitation

    Change from baseline to 2-weeks follow-up after intervention

  • Change in child spontaneous motor imitation

    Change from baseline to 2-weeks follow-up after intervention

Study Arms (2)

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.

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.

Behavioral: music-enhanced Reciprocal Imitation Training

Interventions

Reciprocal Imitation TrainingBEHAVIORAL

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.

Reciprocal Imitation Training (RIT)
music-enhanced Reciprocal Imitation TrainingBEHAVIORAL

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).

Music-Enhanced Reciprocal Imitation Training (meRIT)

Eligibility Criteria

Age18 Months - 36 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • diagnosis of autism / autism spectrum disorder
  • months of age

You may not qualify if:

  • Major hearing or visual impairment (e.g., congenital nystagmus), seizure disorder, genetic syndromes, or gestational age \<=34 weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

MeSH Terms

Conditions

Autistic DisorderAutism Spectrum DisorderCommunication

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersBehavior

Study Officials

  • Miriam Lense

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

  • Warren Jones

    Emory University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Miriam Lense

CONTACT

615-322-3086miriam.lense@vumc.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 10, 2023

First Posted

May 30, 2023

Study Start

July 3, 2023

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Last Updated

May 20, 2026

Record last verified: 2026-05

Locations

US(1)