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CompletedNCT06875843Project VOICESUpdated Jul 30, 2026

Project VOICES: Vocal Optimization in Children Elevating the Spectrum

An interventional study of Contingent responses and Contingent responses plus vocal elicitation strategies in Autism, sponsored by Vanderbilt University Medical Center. Completed at 1 site in United States. Open to participants aged 2 Years to 5 Years. Per ClinicalTrials.gov, last updated 2026-07-30.

Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
3
Allocation
Not applicable
Ages
2 Years to 5 Years
Sex
All
01

Study summary

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.

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Conditions studied

  • Autism

Keywords

  • Autism
  • Language
  • Vocalizations
  • Children
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In context

Autistic Disorder

1,030 studies on the registry are indexed under Autistic Disorder; 266 are open to participants now.

This study's enrollment of 3 is below the median of 49 across 811 interventional studies indexed under Autistic Disorder.

Browse Autistic Disorder studies →

Lead sponsor

Vanderbilt University Medical Center is the lead sponsor of 833 studies on the registry; 155 are open to participants now.

Of its 125 completed or terminated interventional studies of FDA-regulated products, 92 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
2 Years to 5 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Child participants

  • Inclusion criteria

    • Diagnosed with autism spectrum disorder
    • Aged 2 to 5 years old
    • Use no more than 20 words (spoken, signed, or via augmentative and alternative communication) per parent report
    • Use of \< 5 different words during a 15-min communication sample
    • Use of at least one consonant (observed or reported)
    • Primary language of English
  • Exclusion criteria

    • Uncorrected visual or hearing impairment
    • Evidence of severe motor impairment

Caregiver participants

  • Inclusion criteria
  • Have a child enrolled in the study (One caregiver per child participant is enrolled.)
  • Sufficient English skills to complete surveys
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3 participants (actual)

Study arms

  • Experimental
    Contingent responses

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

    Behavioral: Contingent responses · Behavioral: Contingent responses plus vocal elicitation strategies · Behavioral: Non-contingent control

Interventions

  • BehavioralContingent responses

    The adult systematically responds to more complex child vocalizations with more complex responses. When the child first vocalizes, the adult imitates that vocalization. The child's response determines the next adult response. If the child produces a vocalization within 3 seconds, the adult imitates the child, provides a linguistic map (i.e., puts the apparent meaning into words), and complies nonverbally with the child's apparent intent (e.g., giving item or action). If the child does not produce another vocalization within 3 seconds, the adult remains quiet until the child vocalizes again.

  • BehavioralContingent responses plus vocal elicitation strategies

    The adult follows the contingent responses condition protocol with the addition of using vocal toys (e.g., echo tubes, microphones that distort voices, and microphones that amplify voices) within exciting turn-taking activities/routines (e.g., blowing bubbles, balloons, and whoopee cushions). The vocal elicitation strategies emphasize the need to help children vocalize to initiate child-adult interactions. These strategies may be especially important for children who vocalize infrequently to benefit from other intervention aspects and enhance their spoken language skills. The vocal elicitation strategies are to be used when needed, rather than being obligatory for every adult-child interaction. If the child vocalizes without a vocal elicitation prompt, the adult still responds to the vocalization

  • BehavioralNon-contingent control

    The adult provides non-contingent vocal responses based on audio recordings from prior contingent responses condition sessions transmitted via a wireless earpiece. Recordings from these yoked sessions control for number and type of adult vocalizations and minimize the degree of contingency between adult and child vocalizations in this condition.

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What researchers measure

Primary outcomes

  1. Proportion of children for whom the contingent responses with vocal elicitation strategies condition is successful for increasing quantity of vocalizations

    The investigators will calculate the proportion of children for whom the contingent responses with vocal elicitation strategies condition is successful based on the child producing more non-vegetative vocalizations in the contingent responses with vocal elicitation strategies condition than the non-contingent control condition.

    Time frame: Baseline to up to 8 weeks

  2. Proportion of children for whom the contingent responses condition is successful for increasing quantity of vocalizations

    The investigators will calculate the proportion of children for whom the contingent responses is successful based on the child producing more non-vegetative vocalizations in the contingent responses condition than the non-contingent control condition.

    Time frame: Baseline to up to 8 weeks

  3. Proportion of children for whom the contingent responses with vocal elicitation strategies condition provides added value for increasing quantity of vocalizations

    The investigators will calculate the proportion of children for whom the contingent responses is successful based on the child producing more non-vegetative vocalizations in the contingent responses with vocal elicitation strategies condition than the contingent responses condition.

    Time frame: Baseline to up to 8 weeks

Secondary outcomes

  1. Proportion of children for whom the contingent responses with vocal elicitation strategies condition is successful for increasing quality of vocalizations

    Description: The investigators will calculate the proportion of children for whom the contingent responses with vocal elicitation strategies is successful based on the child producing more vocalizations with canonical syllables, more communicative vocalizations, or a higher diversity of key consonants used in communication acts in the contingent responses with vocal elicitation strategies condition than the non-contingent control condition.

    Time frame: Baseline to up to 8 weeks

  2. Proportion of children for whom the contingent responses condition is successful for increasing quality of vocalizations

    Description: The investigators will calculate the proportion of children for whom the contingent responses is successful based on the child producing more vocalizations with canonical syllables, more communicative vocalizations, or a higher diversity of key consonants used in communication acts in the contingent responses condition than the non-contingent control condition.

    Time frame: Baseline to up to 8 weeks

  3. Proportion of children for whom the contingent responses with vocal elicitation strategies condition provides added value for increasing quality of vocalizations

    Description: The investigators will calculate the proportion of children for whom the contingent responses with vocal elicitation strategies condition is successful based on the child producing more vocalizations with canonical syllables, more communicative vocalizations, or a higher diversity of key consonants used in communication acts in the contingent responses with vocal elicitation strategies condition than the contingent responses condition.

    Time frame: Baseline to up to 8 weeks

07

Study locations

1 site
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37232, United States
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References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06875843
Responsible party
Jena McDaniel (Assistant professor, Vanderbilt University Medical Center) — Principal investigator
First posted
Mar 13, 2025
Start date
Apr 25, 2025
Primary completion
Jul 24, 2026
Completion
Jul 24, 2026
Last update
Jul 30, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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