Vanderbilt Clinical Trials

Project VOICES: Vocal Optimization in Children Elevating the Spectrum

Purpose

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.

Condition

Autism

Eligibility

Eligible Ages: Between 2 Years and 5 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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

Study Design

Phase: N/A
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Study Design: Single case alternating treatments design
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
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 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. 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 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.

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37232

More Details

Status: Recruiting
Sponsor: Vanderbilt University Medical Center

Study Contact

Jena McDaniel, PhD
615-936-5114
jena.mcdaniel@vumc.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.