AutismProject VOICESNCT06875843
Project VOICES: Vocal Optimization in Children Elevating the Spectrum
A study testing Contingent responses and Contingent responses plus vocal elicitation strategies in people with Autism, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Autism
- What is being tested?
- Contingent responses and Contingent responses plus vocal elicitation strategies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2025to 24 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
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
- Being tested
- Contingent responses, Contingent responses plus vocal elicitation strategies, Non-contingent control
- Keywords
- Autism, Language, Vocalizations, Children
- Medical subject headings
- Autistic Disorder, Language, Vocalization, Animal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingent responsesBehavioural
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 plus vocal elicitation strategiesBehavioural
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
Non-contingent controlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Contingent responses | Experimental | Participants engage in three conditions: (a) contingent responses, (b) contingent responses with vocal elicitation strategies, (c) non-contingent control Receives: Behavioral: Contingent responses; Behavioral: Contingent responses plus vocal elicitation strategies; Behavioral: Non-contingent control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: Baseline to up to 8 weeks
Proportion of children for whom the contingent responses condition is successful for increasing quality of vocalizations
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.
Measured: 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
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.
Measured: Baseline to up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start25 Apr 2025
- Primary completion24 Jul 2026
- Study completion24 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Study Design: Single case alternating treatments design
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jena McDaniel, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06875843
- Sponsor's protocol ID
- 250043
- Acronym
- Project VOICES
- Status last verified
- Jul 2026
- First submitted
- 7 Mar 2025
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project VOICES: Vocal Optimization in Children Elevating the Spectrum
- ClinicalTrials.gov ID
- NCT06875843
- Acronym / sponsor ID
- Project VOICES / 250043
- Conditions
- Autism
- Keywords
- Autism, Language, Vocalizations, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 25 Apr 2025 (actual)
- Primary completion
- 24 Jul 2026 (actual)
- Study completion
- 24 Jul 2026 (actual)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Study Design: Single case alternating treatments design
| Arm | Type | Receives |
|---|---|---|
| Contingent responses | Experimental | Behavioral: Contingent responses, Behavioral: Contingent responses plus vocal elicitation strategies, Behavioral: Non-contingent controlParticipants engage in three conditions: (a) contingent responses, (b) contingent responses with vocal elicitation strategies, (c) non-contingent control |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
Key exclusion criteria (6 listed)
- Caregiver participants
- Inclusion criteria
- Have a child enrolled in the study (One caregiver per child participant is enrolled.)
- Sufficient English skills to complete surveys
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contingent responsesThe 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. | Behavioural | Contingent responses |
| Contingent responses plus vocal elicitation strategiesThe 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 | Behavioural | Contingent responses |
| Non-contingent controlThe 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. | Behavioural | Contingent responses |
Primary outcome
Proportion of children for whom the contingent responses with vocal elicitation strategies condition is successful for increasing quantity of vocalizations
Time frame: 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
Time frame: 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
Time frame: 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.
3 secondary outcomes
Proportion of children for whom the contingent responses with vocal elicitation strategies condition is successful for increasing quality of vocalizations
Time frame: Baseline to up to 8 weeks
Proportion of children for whom the contingent responses condition is successful for increasing quality of vocalizations
Time frame: 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
Time frame: Baseline to up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contingent responses and Contingent responses plus vocal elicitation strategies in people with Autism, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of children for whom the contingent responses with vocal elicitation strategies condition is successful for increasing quantity of vocalizations (time frame: Baseline to up to 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.