Project VOICES: Vocal Optimization in Children Elevating the Spectrum

Not Applicable

Recruiting

• Conditions: Autism

• Registration Number: NCT06875843
• Lead Sponsor: Vanderbilt University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-07
• Study First Submitted QC: 2025-03-07
• Study First Posted: 2025-03-13
• Status Verified: 2025-04
• Study Start: 2025-04-25
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-02
• Primary Completion: 2028-07
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Proportion of children for whom the contingent responses with vocal elicitation strategies condition is successful for increasing quantity of vocalizations	Baseline to up to 8 weeks	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.
Proportion of children for whom the contingent responses condition is successful for increasing quantity of vocalizations	Baseline to up to 8 weeks	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.
Proportion of children for whom the contingent responses with vocal elicitation strategies condition provides added value for increasing quantity of vocalizations	Baseline to up to 8 weeks	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.

Secondary Outcome Measures

Name	Time	Method
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	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.
Proportion of children for whom the contingent responses condition is successful for increasing quality of vocalizations	Baseline to up to 8 weeks	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.
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	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.

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States