Project VOICES: Vocal Optimization in Children Elevating the Spectrum

NCT06875843 | Recruiting

• 1 other identifier: 250043
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Autism; Language; Vocalizations; Children

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline to up to 8 weeks

• 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.

  Baseline to up to 8 weeks

• 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.

  Baseline to up to 8 weeks

Secondary Outcomes (3)

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

  Baseline to up to 8 weeks

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

  Baseline to up to 8 weeks

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

  Baseline to up to 8 weeks

Study Arms (1)

Contingent responses

EXPERIMENTAL

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

Contingent responses 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

Contingent responses plus vocal elicitation strategies 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

Contingent responses

Non-contingent control 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.

Contingent responses

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Uncorrected visual or hearing impairment
• Evidence of severe motor impairment
• Caregiver participants
• Have a child enrolled in the study (One caregiver per child participant is enrolled.)
• Sufficient English skills to complete surveys

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

MeSH Terms

Conditions

Autistic Disorder; Language; Vocalization, Animal

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Communication; Behavior; Animal Communication; Behavior, Animal

Central Study Contacts

Jena McDaniel, PhD

CONTACT

615-936-5114; jena.mcdaniel@vumc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: Study Design: Single case alternating treatments design

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 13, 2025
• Study Start: April 25, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 2, 2025

Record last verified: 2025-04

Locations

US (1)