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Reciprocal Imitation Training and Musical Rhythm Sensitivity in Autistic Toddlers

Primary Purpose

Autism, Autism Spectrum Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reciprocal Imitation Training
music-enhanced Reciprocal Imitation Training
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Autism focused on measuring autism, imitation, social communication, rhythm, music

Eligibility Criteria

18 Months - 36 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Reciprocal Imitation Training (RIT)

Music-Enhanced Reciprocal Imitation Training (meRIT)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Change in child elicited motor imitation
Children's performance on the Motor Imitation Scale (score 0-32). Higher scores indicate greater performance.
Change in child spontaneous motor imitation
Children's performance on the Unstructured Imitation Assessments (score 0-20)

Full Information

First Posted
May 10, 2023
Last Updated
May 18, 2023
Sponsor
Vanderbilt University Medical Center
Collaborators
National Institute of Mental Health (NIMH), National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT05880225
Brief Title
Reciprocal Imitation Training and Musical Rhythm Sensitivity in Autistic Toddlers
Official Title
Musical Rhythm Sensitivity to Scaffold Social Engagement in Autism Spectrum Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 3, 2024 (Anticipated)
Primary Completion Date
April 30, 2026 (Anticipated)
Study Completion Date
April 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
National Institute of Mental Health (NIMH), National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism, Autism Spectrum Disorder
Keywords
autism, imitation, social communication, rhythm, music

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Reciprocal Imitation Training (RIT)
Arm Type
Active Comparator
Arm Description
Children (n=20) receive 30 sessions of Reciprocal Imitation Training (RIT), delivered in 40-60 minute sessions 2-3 times/week.
Arm Title
Music-Enhanced Reciprocal Imitation Training (meRIT)
Arm Type
Experimental
Arm Description
Children (n=20) receive 30 sessions of music-enhanced Reciprocal Imitation Training (meRIT), delivered in 40-60 minute sessions 2-3 times/week.
Intervention Type
Behavioral
Intervention Name(s)
Reciprocal Imitation Training
Intervention Description
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
Intervention Name(s)
music-enhanced Reciprocal Imitation Training
Intervention Description
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 Outcome Measure Information:
Title
Change in rhythmically entrained eye-looking (eye-tracking)
Description
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
Secondary Outcome Measure Information:
Title
Change in overall fixation to eyes (eye-tracking)
Description
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
Title
Change in child elicited motor imitation
Description
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
Title
Change in child spontaneous motor imitation
Description
Children's performance on the Unstructured Imitation Assessments (score 0-20)
Time Frame
Change from baseline to 2-weeks follow-up after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miriam Lense
Phone
615-322-3086
Email
miriam.lense@vumc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miriam Lense
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Warren Jones
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

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Reciprocal Imitation Training and Musical Rhythm Sensitivity in Autistic Toddlers

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