Reciprocal Imitation Training and Musical Rhythm Sensitivity in Autistic Toddlers

Sponsor
Vanderbilt University Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05880225
Collaborator
National Institute of Mental Health (NIMH) (NIH), National Center for Complementary and Integrative Health (NCCIH) (NIH)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Reciprocal Imitation Training
  • Behavioral: music-enhanced Reciprocal Imitation Training
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Musical Rhythm Sensitivity to Scaffold Social Engagement in Autism Spectrum Disorder
Anticipated Study Start Date :
Jan 3, 2024
Anticipated Primary Completion Date :
Apr 30, 2026
Anticipated Study Completion Date :
Apr 30, 2026

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

Behavioral: 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.

Experimental: 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.

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).

Outcome Measures

Primary Outcome Measures

  1. Change in rhythmically entrained eye-looking (eye-tracking) [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 Outcome Measures

  1. Change in overall fixation to eyes (eye-tracking) [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 [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 [Change from baseline to 2-weeks follow-up after intervention]

    Children's performance on the Unstructured Imitation Assessments (score 0-20)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Months to 36 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vanderbilt University Medical Center Nashville Tennessee United States 37232

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Miriam Lense, Vanderbilt University Medical Center
  • Principal Investigator: Warren Jones, Emory University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Miriam Lense, Assistant Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:
NCT05880225
Other Study ID Numbers:
  • MH123029
First Posted:
May 30, 2023
Last Update Posted:
May 30, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Miriam Lense, Assistant Professor, Vanderbilt University Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 30, 2023