Clinical trial NCT06875843: Project VOICES: Vocal Optimization in Children Elevating the Spectrum
Official title: Project VOICES: Vocal Optimization in Children Elevating the Spectrum
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism
Keywords: Autism
Language
Vocalizations
Children
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2025-03-13
Enrollment: 20
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Study Design: Single case alternating treatments design
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Proportion of children for whom the contingent responses with vocal elicitation strategies condition is successful for increasing quantity of vocalizations
timeFrame: Baseline to up to 8 weeks
measure: Proportion of children for whom the contingent responses condition is successful for increasing quantity of vocalizations
timeFrame: Baseline to up to 8 weeks
measure: Proportion of children for whom the contingent responses with vocal elicitation strategies condition provides added value for increasing quantity of vocalizations
timeFrame: Baseline to up to 8 weeks
Secondary outcomes:
measure: Proportion of children for whom the contingent responses with vocal elicitation strategies condition is successful for increasing quality of vocalizations
timeFrame: Baseline to up to 8 weeks
measure: Proportion of children for whom the contingent responses condition is successful for increasing quality of vocalizations
timeFrame: Baseline to up to 8 weeks
measure: Proportion of children for whom the contingent responses with vocal elicitation strategies condition provides added value for increasing quality of vocalizations
timeFrame: Baseline to up to 8 weeks
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References: