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Project VOICES: Vocal Optimization in Children Elevating the Spectrum

Project VOICES: Vocal Optimization in Children Elevating the Spectrum

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06875843
Acronym
Project VOICES
Enrollment
3
Registered
2025-03-13
Start date
2025-04-25
Completion date
2026-07-24
Last updated
2026-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism

Keywords

Autism, Language, Vocalizations, Children

Brief 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.

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

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.

Sponsors

Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Study Design: Single case alternating treatments design

Eligibility

Sex/Gender
ALL
Age
2 Years to 5 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of children for whom the contingent responses with vocal elicitation strategies condition is successful for increasing quantity of vocalizationsBaseline to up to 8 weeksThe 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.
Proportion of children for whom the contingent responses condition is successful for increasing quantity of vocalizationsBaseline to up to 8 weeksThe 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.
Proportion of children for whom the contingent responses with vocal elicitation strategies condition provides added value for increasing quantity of vocalizationsBaseline to up to 8 weeksThe 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.

Secondary

MeasureTime frameDescription
Proportion of children for whom the contingent responses with vocal elicitation strategies condition is successful for increasing quality of vocalizationsBaseline to up to 8 weeksDescription: 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.
Proportion of children for whom the contingent responses condition is successful for increasing quality of vocalizationsBaseline to up to 8 weeksDescription: 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.
Proportion of children for whom the contingent responses with vocal elicitation strategies condition provides added value for increasing quality of vocalizationsBaseline to up to 8 weeksDescription: 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 31, 2026