Hearing Impaired ChildrenProject PAIRNCT06936696
Project PAIR: Parent-implemented Articulation Intervention With Recast
A study testing Broad Target Speech Recast and Traditional Speech Therapy in people with Hearing Impaired Children, run by Vanderbilt University at 1 site in United States.
Trial summary
Using a single-case multiple baseline across participants design, this study aims to explore the effectiveness of parent-implemented Broad Treatment Speech Recast supplemented with traditional clinician-led articulation therapy on speech production in elementary-aged deaf and hard of hearing children. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Hearing Impaired Children
- What is being tested?
- Broad Target Speech Recast and Traditional Speech Therapy
- 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
- 10 Jun 2025to 9 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 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 4;0-9;11
- Permanent, prelingual sensorineural hearing loss
- Uses spoken English as their primary home language (≥ 51% of the time)
- Standard score ≥70 on the Leiter
- Standard score ≥70 on the OWLS-II Listening Comprehension
- At least two speech sound errors appropriate to target based on speech norms and general stimulability
Who cannot join
- Motor speech disorder (e.g., childhood apraxia of speech)
- Oral structural functional disorder (e.g., cleft palate)
- Diagnosis of autism spectrum disorder
- Diagnosis of ADHD
- Uncorrected vision impairment (i.e., identified vision loss without the use of corrective lenses)
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Using a single-case multiple baseline across participants design, this study aims to explore the effectiveness of parent-implemented Broad Treatment Speech Recast supplemented with traditional clinician-led articulation therapy on speech production in elementary-aged deaf and hard of hearing children.
To address these objectives, the following research questions will be investigated:
- Does drill-based articulation therapy, administered by a speech-language pathologist, improve speech sound production in DHH children when parent-implemented BTSR is concurrently utilized at home?
- Does the combination of parent-implemented BTSR and clinician-led traditional articulation therapy result in generalization of speech sound accuracy at the conversation level?
- Conditions
- Hearing Impaired Children
- Being tested
- Broad Target Speech Recast, Traditional Speech Therapy
- Keywords
- deaf and hard of hearing, articulation, speech sound production, parent training, children
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Broad Target Speech RecastBehavioural
Also called BTSR
Broad Target Speech Recasts (BTSR) is a speech intervention technique in which an adult immediately recasts a child's incorrect articulation by providing a corrected version of the word in a naturalistic, meaningful context. Unlike traditional articulation therapy, which focuses on isolated sound drills, BTSR integrates correction seamlessly into conversation without requiring the child to repeat or imitate the model.
This approach is rooted in principles of implicit learning, where repeated exposure to accurate speech models facilitates phonological development over time. BTSR differs from traditional minimal pair or phonetic placement techniques in that it does not involve explicit instruction or direct prompts for self-correction. Instead, it provides high-frequency, naturalistic exposure to correct phoneme production within functional language use.
Traditional Speech TherapyBehavioural
Traditional Speech Therapy is clinician-led and includes structured, drill-based approaches. Techniques such as placement cues, direct feedback, and reinforcement are used to help children achieve correct articulation. The structured nature of this approach is often more effective in remediating persistent speech errors than parent-implemented strategies alone.
This study examines whether the combination of parent-implemented BTSR and clinician-led traditional articulation therapy leads to improved speech sound production and long-term maintenance of correct articulation in elementary-aged DHH children.
| Study group | Role | What they receive |
|---|---|---|
| Articulation Therapy | Experimental | Participants engage in two conditions: (1) Parent-implemented Broad Target Speech Recast (BTSR), (2) Parent-implemented BTSR combined with clinician-implemented speech therapy
This is a nonconcurrent multiple probe single-case experimental design with staggered introduction of conditions across participants. All participants receive both interventions, but the interventions are introduced in separate phases and evaluated independently and in combination.
This is not a crossover or parallel group design. Rather than having separate arms or randomization, each participant serves as their own control over time, allowing for individualized evaluation of intervention effects. Receives: Behavioral: Broad Target Speech Recast; Behavioral: Traditional Speech Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target phoneme production accuracy
The percent of accurate phoneme productions per target, which is derived by dividing the number of correct productions by the total possible points for each target and then multiplying by 100. Accurate phoneme production is defined by a speech-language pathologist's judgment of perceptual accuracy through the lens of broad transcription.
Measured: From baseline until end of treatment (when intervention criteria have been reached or 6 weeks of no progress / regression)
Secondary outcomes (2)
Goldman Fristoe Test of Articulation - Third Edition (GFTA-3)
The Goldman-Fristoe Test of Articulation, Third Edition (GFTA-3) is a standardized assessment used to evaluate speech sound production in children, adolescents, and young adults (ages 2;0-21;11). It measures articulation skills by assessing a child's ability to produce consonant sounds in different word positions (initial, medial, final) and in connected speech. The test provides standard scores, percentile ranks, and age-equivalent scores.
Scores are standardized with a mean of 100 and a standard deviation of 15. Standard scores range from 40 to 160, with higher scores indicating better articulation abilities.
Measured: Collected during eligibility (before the intervention) and at the end of the intervention (when intervention criteria have been reached or 6 weeks of no progress / regression)
Generalization to Conversation
Connected speech samples will involve a ten-minute conversation or play-based dialog initiated by the examiner or parent to elicit natural speech from the child. Various techniques may be employed to encourage a sample abundant in expressive language, including the use of open-ended questions and engagement in child-led pretend play. This task will occur at three time-points throughout the study (baseline, BTSR phase, after intervention criteria has been reached) to measure generalization, and it should be administered after the listening check and before the probe. This task will be captured on video for later analysis. Accuracy of phoneme targets will be calculated using percent of consonants correct.
Measured: From enrollment to the end of treatment (when child meets criteria or exhibits no progress/regression for three consecutive sessions).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start10 Jun 2025
- Primary completion25 Jun 2026
- Study completion9 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Impaired ChildrenStudies of the same condition, open and under way.
- 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
- Single case multiple baseline across participants
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meganne Muir, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06936696
- Sponsor's protocol ID
- 240777
- Acronym
- Project PAIR
- Status last verified
- Jul 2026
- First submitted
- 13 Apr 2025
- Last updated
- 23 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 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project PAIR: Parent-implemented Articulation Intervention With Recast
- ClinicalTrials.gov ID
- NCT06936696
- Acronym / sponsor ID
- Project PAIR / 240777
- Conditions
- Hearing Impaired Children
- Keywords
- deaf and hard of hearing, articulation, speech sound production, parent training, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- 25 Jun 2026 (actual)
- Study completion
- 9 Jul 2026 (actual)
- First posted
- 20 Apr 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.
Using a single-case multiple baseline across participants design, this study aims to explore the effectiveness of parent-implemented Broad Treatment Speech Recast supplemented with traditional clinician-led articulation therapy on speech production in elementary-aged deaf and hard of hearing children.
To address these objectives, the following research questions will be investigated:
- Does drill-based articulation therapy, administered by a speech-language pathologist, improve speech sound production in DHH children when parent-implemented BTSR is concurrently utilized at home?
- Does the combination of parent-implemented BTSR and clinician-led traditional articulation therapy result in generalization of speech sound accuracy at the conversation level?
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single case multiple baseline across participants
| Arm | Type | Receives |
|---|---|---|
| Articulation Therapy | Experimental | Behavioral: Broad Target Speech Recast, Behavioral: Traditional Speech TherapyParticipants engage in two conditions: (1) Parent-implemented Broad Target Speech Recast (BTSR), (2) Parent-implemented BTSR combined with clinician-implemented speech therapy This is a nonconcurrent multiple probe single-case experimental design with staggered introduction of conditions across participants. All participants receive both interventions, but the interventions are introduced in separate phases and evaluated independently and in combination. This is not a crossover or parallel group design. Rather than having separate arms or randomization, each participant serves as their own control over time, allowing for individualized evaluation of intervention effects. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age 4;0-9;11
- Permanent, prelingual sensorineural hearing loss
- Uses spoken English as their primary home language (≥ 51% of the time)
- Standard score ≥70 on the Leiter
- Standard score ≥70 on the OWLS-II Listening Comprehension
Key exclusion criteria (5 listed)
- Motor speech disorder (e.g., childhood apraxia of speech)
- Oral structural functional disorder (e.g., cleft palate)
- Diagnosis of autism spectrum disorder
- Diagnosis of ADHD
- Uncorrected vision impairment (i.e., identified vision loss without the use of corrective lenses)
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 |
|---|---|---|
| Broad Target Speech RecastAlso: BTSRBroad Target Speech Recasts (BTSR) is a speech intervention technique in which an adult immediately recasts a child's incorrect articulation by providing a corrected version of the word in a naturalistic, meaningful context. Unlike traditional articulation therapy, which focuses on isolated sound drills, BTSR integrates correction seamlessly into conversation without requiring the child to repeat or imitate the model. This approach is rooted in principles of implicit learning, where repeated exposure to accurate speech models facilitates phonological development over time. BTSR differs from traditional minimal pair or phonetic placement techniques in that it does not involve explicit instruction or direct prompts for self-correction. Instead, it provides high-frequency, naturalistic exposure to correct phoneme production within functional language use. | Behavioural | Articulation Therapy |
| Traditional Speech TherapyTraditional Speech Therapy is clinician-led and includes structured, drill-based approaches. Techniques such as placement cues, direct feedback, and reinforcement are used to help children achieve correct articulation. The structured nature of this approach is often more effective in remediating persistent speech errors than parent-implemented strategies alone. This study examines whether the combination of parent-implemented BTSR and clinician-led traditional articulation therapy leads to improved speech sound production and long-term maintenance of correct articulation in elementary-aged DHH children. | Behavioural | Articulation Therapy |
Primary outcome
Target phoneme production accuracy
Time frame: From baseline until end of treatment (when intervention criteria have been reached or 6 weeks of no progress / regression)
The percent of accurate phoneme productions per target, which is derived by dividing the number of correct productions by the total possible points for each target and then multiplying by 100. Accurate phoneme production is defined by a speech-language pathologist's judgment of perceptual accuracy through the lens of broad transcription.
2 secondary outcomes
Goldman Fristoe Test of Articulation - Third Edition (GFTA-3)
Time frame: Collected during eligibility (before the intervention) and at the end of the intervention (when intervention criteria have been reached or 6 weeks of no progress / regression)
Generalization to Conversation
Time frame: From enrollment to the end of treatment (when child meets criteria or exhibits no progress/regression for three consecutive sessions).
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 23 Jul 2026.
Related trials for Hearing Impaired Children
Recruiting
Evaluation of Cochlear Implantation in Unilateral or Asymmetric Hearing Loss in Children.
Unilateral Hearing Loss, Asymmetric Hearing Loss
Recruiting
Towards Implementation of Universal Newborn Hearing Screening in Kenya
Hearing Loss, Bilateral or Unilateral, Otitis Media With Effusion in Children
Not yet recruiting
Outcomes of Cartilage Tympanoplasty in Children
Tympanic Membrane Perforation, Conductive Hearing Loss
RecruitingObservational study
Alpha-Tectorin, Interleukin-10 and Thiol-Disulfide Homeostasis in Children With Congenital Hearing Loss
Congenital Hearing Loss, Sensorineural Hearing Loss
Not yet recruiting
Hearing Intervention Effects on Brain and Language Development in Children With Bilateral Mild Hearing Loss
Hearing Loss, Bilateral
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 Broad Target Speech Recast and Traditional Speech Therapy in people with Hearing Impaired Children, run by Vanderbilt University 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 5 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 23 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?
Target phoneme production accuracy (time frame: From baseline until end of treatment (when intervention criteria have been reached or 6 weeks of no progress / regression)). 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 23 Jul 2026.