Reciprocal Imitation Training and Musical Rhythm Sensitivity in Autistic Toddlers

Autism Spectrum Disorder Clinical Trial

Official title:

Musical Rhythm Sensitivity to Scaffold Social Engagement in Autism Spectrum Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05880225
• Other study ID #: MH123029
• Status: Recruiting
• Phase: N/A
• Start date: July 3, 2023
• Est. completion date: April 30, 2026

Study information

• Verified date: April 2024
• Source: Vanderbilt University Medical Center
• Contact: Miriam Lense
• Phone: 615-322-3086
• Email: miriam.lense[@]vumc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 30, 2026
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months to 36 Months

Eligibility

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.

Related Conditions & MeSH terms

• Autism
• Autism Spectrum Disorder
• Autistic Disorder

Intervention

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.
• 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).

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	National Center for Complementary and Integrative Health (NCCIH), National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 from baseline through 2-week follow-up post-intervention
Secondary	Change in child elicited motor imitation	Children's performance on the Motor Imitation Scale (score 0-32). Higher scores indicate greater performance.	Change from baseline to 2-weeks follow-up after intervention
Secondary	Change in child spontaneous motor imitation	Children's performance on the Unstructured Imitation Assessments (score 0-20)	Change from baseline to 2-weeks follow-up after intervention