Vocal Optimization for Autism Spectrum Disorder

(Project VOICES Trial)

Overseen By Jena McDaniel, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Uncorrected visual, hearing, severe motor, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Contingent responses plus vocal elicitation strategies for Autism Spectrum Disorder?

Research shows that using response-contingent pairing (RCP) and observational conditioning (OC) can increase vocalizations in children with autism, suggesting these methods might help improve communication skills. ^{1 2 3 4 5}

Is the Vocal Optimization treatment safe for humans?

The research articles provided do not contain specific safety data for the Vocal Optimization treatment or its related methods. They focus on the effects of music and vocal training on behavior in children with autism, but do not address safety concerns. ^{2 6 7 8 9}

How does the treatment 'Contingent responses plus vocal elicitation strategies' differ from other treatments for Autism Spectrum Disorder?

This treatment is unique because it focuses on using specific vocal strategies to encourage speech in children with autism, which may involve pairing sounds to increase vocalizations. Unlike other treatments that might focus on broader behavioral or social skills, this approach targets vocal communication directly, potentially offering a more tailored intervention for speech development. ^{5 6 10 11 12}

What is the purpose of this trial?

Thirty percent of children with autism barely talk or do not talk at all despite years of intervention. This study aims to address this important and long-standing challenge by developing a novel intervention to increase the quantity and quality of vocalizations (i.e., sounds children make before words) and expressive language in young children with autism (aged 2 to 5 years) with minimal verbal skills. The intervention includes contingent responses to the child's vocalizations and vocal elicitation strategies. We also collect social validity information from parents about how they perceive the novel intervention.

Eligibility Criteria

This trial is for young children aged 2 to 5 with autism who speak less than five words during a communication sample and use no more than twenty words overall. They must have at least one consonant in their vocal range, whether observed or reported, and primarily communicate in English.

Inclusion Criteria

I use 20 words or less, as reported by my parent.

I use less than 5 different words when I talk for 15 minutes.

*

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in contingent responses and vocal elicitation strategies to increase vocalizations

8 weeks

Follow-up

Participants are monitored for changes in vocalization quality and quantity after the intervention

4 weeks

Treatment Details

Interventions

• Contingent responses plus vocal elicitation strategies

Trial Overview The study tests a new intervention designed to improve the quantity and quality of sounds before speech (vocalizations) and expressive language in minimally verbal kids with autism. It involves responding to child vocalizations and strategies to encourage them to make sounds.

Participant Groups

Group I: Contingent responses Experimental Treatment 3 Interventions

Participants engage in three conditions: (a) contingent responses, (b) contingent responses with vocal elicitation strategies, (c) non-contingent control

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Assessing the Effects of Observational Conditioning and Response-Contingent Pairing on the Vocalizations of Children With Autism Spectrum Disorder. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A meta-analysis of the association between vocalizations and expressive language in children with autism spectrum disorder. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Speak Up: Increasing Conversational Volume in a Child with Autism Spectrum Disorder. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Further investigation of increasing vocalizations of children with autism with a speech-generating device. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Atypical Sound Perception in ASD Explained by Inter-Trial (In)consistency in EEG. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

The utility of assessing musical preference before implementation of noncontingent music to reduce vocal stereotypy. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

Auditory preference of children with autism spectrum disorders. [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

The effects of a stimulus-stimulus pairing procedure on the vocal behavior of children diagnosed with autism. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

A comparison of stimulus-stimulus pairing, standard echoic training, and control procedures on the vocal behavior of children with autism. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

An evaluation of the number of presentations of target sounds during stimulus-stimulus pairing trials. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Review of methods for conducting speech research with minimally verbal individuals with autism spectrum disorder. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

"Is voice a marker for Autism spectrum disorder? A systematic review and meta-analysis". [2018]