Clinical trial NCT05880225: 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
Overall status: RECRUITING
Phase: NA
Conditions: Autism
Autism Spectrum Disorder
Keywords: autism
imitation
social communication
rhythm
music
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2023-05-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in rhythmically entrained eye-looking (eye-tracking)
timeFrame: Change from baseline through 2-week follow-up post-intervention
Secondary outcomes:
measure: Change in overall fixation to eyes (eye-tracking)
timeFrame: Change from baseline through 2-week follow-up post-intervention
measure: Change in child elicited motor imitation
timeFrame: Change from baseline to 2-weeks follow-up after intervention
measure: Change in child spontaneous motor imitation
timeFrame: Change from baseline to 2-weeks follow-up after intervention
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Miriam Lense
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Warren Jones
role: PRINCIPAL_INVESTIGATOR
References: