Music-Enhanced Reciprocal Imitation Training for Autism in Toddlers

Overseen By Miriam Lense

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Hearing impairment, Seizure disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 10-15 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how toddlers with autism respond to special training that aids imitation and social skills. One group will receive regular Reciprocal Imitation Training, while another will receive the same training with added music (music-enhanced Reciprocal Imitation Training). Researchers aim to determine if rhythm sensitivity can predict the toddlers' response to these interventions. This study may suit toddlers diagnosed with autism who are 18 to 36 months old and do not have significant hearing or vision problems. As an unphased trial, it offers parents a unique opportunity to contribute to understanding innovative approaches that may enhance social skills in toddlers with autism.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Reciprocal Imitation Training (RIT), including a music-based version, is generally safe for toddlers. Previous studies examined the music-based RIT and found that parents could learn and implement the training without serious issues.

The music-enhanced RIT, often delivered through online sessions, aims to improve social communication skills in autistic children. These studies reported no negative effects, suggesting the treatment is well-tolerated.

Although this study lacks specific safety data, past research has successfully used RIT. This background supports its general safety for toddlers involved in the training. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they explore innovative ways to support toddlers with autism through Reciprocal Imitation Training (RIT). Unlike typical approaches that may focus heavily on structured therapy sessions, the music-enhanced version (meRIT) integrates music to potentially boost engagement and learning. This use of music is believed to enhance social interaction and imitation skills more effectively. By comparing traditional RIT with a music-enhanced version, researchers aim to discover if adding music can make a significant difference in improving social communication in young children with autism.

What evidence suggests that this trial's treatments could be effective for autism in toddlers?

Research shows that Reciprocal Imitation Training (RIT), one of the treatments in this trial, can improve imitation and social communication skills in children with autism. The trial will also examine Music-Enhanced Reciprocal Imitation Training (meRIT), another treatment arm, which may boost children's engagement and responsiveness. In one study where parents used meRIT at home, all parents improved their use of RIT techniques and met the treatment goals by the end. This finding suggests that adding music might enhance traditional RIT methods. Although more research is needed, early evidence indicates that music could be a promising addition to help autistic toddlers develop social and communication skills. ^{1 2 3 5 6}

Who Is on the Research Team?

Warren Jones

Principal Investigator

Emory University

Miriam Lense

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for toddlers aged 18-36 months who have been diagnosed with autism or autism spectrum disorder. It's designed to help improve their imitation and social communication skills.

Inclusion Criteria

I have been diagnosed with autism or ASD.

I am between 18 and 36 months old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Children's rhythm sensitivity is assessed via eye-tracking sessions

1-2 weeks

Treatment

Participants receive 30 sessions of either Reciprocal Imitation Training (RIT) or music-enhanced RIT (meRIT)

10-15 weeks

2-3 sessions per week

Follow-up

Participants are monitored for changes in rhythm sensitivity and imitation skills

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• music-enhanced Reciprocal Imitation Training
• Reciprocal Imitation Training

Trial Overview The study tests two types of training: standard Reciprocal Imitation Training (RIT) and a music-enhanced version of RIT, to see which better supports the development of autistic toddlers.

How Is the Trial Designed?

Group I: Music-Enhanced Reciprocal Imitation Training (meRIT) Experimental Treatment 1 Intervention

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

Group II: Reciprocal Imitation Training (RIT) Active Control 1 Intervention

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

music-enhanced Reciprocal Imitation Training is already approved in United States, European Union for the following indications:

Approved in United States as Reciprocal Imitation Training for:

• Autism Spectrum Disorder (ASD)

Approved in European Union as Reciprocal Imitation Training for:

• Autism Spectrum Disorder (ASD)

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Published Research Related to This Trial

Reciprocal imitation training (RIT) effectively teaches children with autism spectrum disorder (ASD) to imitate gestures and objects, leading to improvements in spontaneous language use.

In a study involving 4 children, adding gesture imitation training resulted in greater language use for 3 of the participants, indicating that combining gesture and object imitation training can enhance language development in children with ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of object and gesture imitation training on language use in children with autism spectrum disorder. Ingersoll, B., Lalonde, K.[2023]

The study demonstrated that a telehealth adaptation of Reciprocal Imitation Training (tele-meRIT) is feasible for coaching parents of autistic children, with all participating parents achieving implementation fidelity by the end of the treatment.

Parents reported high satisfaction with tele-meRIT, noting perceived improvements in their children's social and play skills, despite the intervention not consistently enhancing children's imitation skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Report: Telehealth Music-Enhanced Reciprocal Imitation Training in Autism: A Single-Subject Feasibility Study of a Virtual Parent Coaching Intervention. Liu, T., Martinez-Torres, K., Mazzone, J., et al.[2023]

After training in Reciprocal Imitation Training (RIT), 66 Early Intervention providers reported significant increases in their confidence and self-efficacy in delivering services to children with Autism Spectrum Disorder (ASD).

Providers successfully adopted RIT with over 400 families, indicating high feasibility and perceived effectiveness, especially for children with social-communication or motor imitation delays, suggesting RIT could be a valuable early intervention in community settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The implementation of reciprocal imitation training in a Part C early intervention setting: A stepped-wedge pragmatic trial. Ibañez, LV., Scott, S., Stone, WL.[2022]

Reciprocal Imitation Training (RIT) effectively improved the imitation of descriptive gestures in five young children with autism, as demonstrated by increased gesture imitation in both treatment settings and structured assessments.

The gains from RIT not only generalized to different therapists and settings but also maintained over a month, with some children showing increased spontaneous use of gestures, highlighting the intervention's potential for long-term benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teaching the imitation and spontaneous use of descriptive gestures in young children with autism using a naturalistic behavioral intervention. Ingersoll, B., Lewis, E., Kroman, E.[2019]

Reciprocal Imitation Training (RIT) significantly improved both elicited and spontaneous imitation skills in 21 young children with autism, demonstrating its efficacy as a naturalistic intervention.

The study found that children with a larger repertoire of spontaneous play acts before treatment showed greater improvements in imitation skills during RIT, indicating that existing play skills may enhance the effectiveness of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot randomized controlled trial of Reciprocal Imitation Training for teaching elicited and spontaneous imitation to children with autism. Ingersoll, B.[2023]

Reciprocal imitation training is an effective intervention for improving social imitation skills in young children with autism, and it can be easily taught to parents and caregivers for home use.

The study found that providing 1:1 coaching to parents significantly improved their ability to implement the training, which in turn led to increased spontaneous imitation behaviors in some children with autism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of coaching on the fidelity of parent implementation of reciprocal imitation training. Penney, A., Schwartz, I.[2020]

Reciprocal imitation training (RIT) effectively teaches spontaneous imitation skills to young children with autism, as demonstrated in a study involving three children and their mothers over 10 weeks.

Parents were able to successfully implement RIT techniques, leading to significant increases in their children's ability to imitate actions and gestures, showing that this intervention can be effectively used in naturalistic settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a parent-implemented imitation intervention on spontaneous imitation skills in young children with autism. Ingersoll, B., Gergans, S.[2007]

Reciprocal imitation training and video modeling were both effective interventions for improving imitation skills in young children with autism, as demonstrated in a study involving six boys matched by age, language, and autism severity.

All participants showed increased imitation abilities that not only improved during treatment but also maintained and generalized to higher levels after the interventions, highlighting the potential of these methods in skill development for children with autism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting imitation in young children with autism: a comparison of reciprocal imitation training and video modeling. Cardon, TA., Wilcox, MJ.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10834845/

Telehealth Music-Enhanced Reciprocal Imitation Training ... The primary aim is to examine parent fidelity of implementation of RIT with the added musicality of meRIT delivered via tele-health (tele-meRIT) ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05880225

Reciprocal Imitation Training and Musical Rhythm ... Children's rhythm sensitivity is assessed via repeated eye-tracking sessions throughout baseline, intervention, and two-weeks after the intervention ends.

3. researchgate.net researchgate.net/publication/372859691_Brief_Report_Telehealth_Music-Enhanced_Reciprocal_Imitation_Training_in_Autism_A_Single-Subject_Feasibility_Study_of_a_Virtual_Parent_Coaching_Intervention

Telehealth Music-Enhanced Reciprocal Imitation Training ... Parent-child dyads were recorded during 10-min free play probes at baseline, weekly tele-meRIT sessions, and one-week and one-month follow-up.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37530912/

Telehealth Music-Enhanced Reciprocal Imitation Training in ... We evaluate the feasibility of a music-based, telehealth adaptation of RIT-music-enhanced RIT (tele-meRIT)-as a novel format for coaching parents in NDBI ...

5. eric.ed.gov eric.ed.gov/?id=EJ1478235

Telehealth Music-Enhanced Reciprocal Imitation Training ... Results: No parent demonstrated implementation fidelity during baseline. All parents increased their use of RIT strategies, met fidelity by the end of treatment ...

6. vumc.org vumc.org/music-cognition-lab/publication/brief-report-telehealth-music-enhanced-reciprocal-imitation-training-autism-single

Telehealth Music-Enhanced Reciprocal Imitation Training ... Telehealth delivery increases accessibility of parent-mediated interventions that teach parents skills and support autistic children's social communication.