Project VOICES: Vocal Optimization in Children Elevating the Spectrum

NCT ID: NCT06875843

Last Updated: 2025-05-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-25
• Study Completion Date: 2028-12-31

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.

Conditions

Autism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Contingent responses

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

Group Type: EXPERIMENTAL

Contingent responses

Intervention Type: BEHAVIORAL

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.

Contingent responses plus vocal elicitation strategies

Intervention Type: BEHAVIORAL

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

Non-contingent control

Intervention Type: BEHAVIORAL

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.

Interventions

Contingent 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.

Intervention Type: BEHAVIORAL

Contingent 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

Intervention Type: BEHAVIORAL

Non-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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

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

Exclusion Criteria

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

Caregiver participants

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jena McDaniel

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jena McDaniel, PhD

Role: CONTACT

jena.mcdaniel@vumc.org

615-936-5114

Other Identifiers

250043

Identifier Type: -

Identifier Source: org_study_id