Project VOICES: Vocal Optimization in Children Elevating the Spectrum

Vanderbilt University Medical Center

Status: Enrolling

Conditions: Autism

Treatments: Behavioral: Contingent responses plus vocal elicitation strategies; Behavioral: Contingent responses; Behavioral: Non-contingent control

Study type: Interventional

Funder types: Other

Identifiers

NCT06875843

250043

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 2 to 5 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Contingent responses

Experimental group

Description:

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

Treatment:

Behavioral: Non-contingent control

Behavioral: Contingent responses

Behavioral: Contingent responses plus vocal elicitation strategies