Language DevelopmentTWMBNCT06479278
Talk With Me Baby to Enhance the Early Home Language Environment
A study testing Talk with Me Baby in people with Language Development and Speech, run by IDeA States Pediatric Clinical Trials Network at 2 sites in United States.
Trial summary
The goal of this clinical trial is to learn if the Talk With Me Baby (TWMB) program improves the home-language environment for at-risk families with children ages two to six months when primary care providers deliver the program during well-child checkups. Read more about this study
- Who is it for?
- Ages 0 to 9 monthsHealthy volunteers can take part
- Conditions the study is for
- Language Development, Speech, Infant Development
- What is being tested?
- Talk with Me Baby
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Feb 2025to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 0 to 9 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- For this study, each child-caregiver dyad will consist of:
- A caregiver who will receive TWMB during routine WCC visits for their child at participating clinics, and
- The child of the above caregiver for whom the WCC visits are conducted.
- A potential caregiver participant must meet all the following inclusion criteria to enroll in the study:
- Be the age of majority, or older, as defined by the state of residency.
- Able to complete study measures in English.
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- Have the legal authority to consent to participate for themselves and to consent on behalf of their child.
- To proceed to the follow-up portion of the study the caregiver (dyad) must have a LENA baseline assessment score that is ≤ 75th percentile compared to a child's age-referenced normative data.
- A potential child participant must meet all the following inclusion criteria to be enrolled in the study:
- Receive WCC at a participating clinic from a participating provider.
- Be zero to nine months (+ 0-30 days) old at enrollment.
- Was born at full term (> 37 weeks gestation).
- Was born in a singleton birth (i.e., was the only child delivered during the birth).
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Kansas University Medical Center
Kansas City, Kansas, 66160
Brenda Salley, PhD, 913-945-7944, bsalley@kumc.edu
- Not yet recruiting
West Virginia University
Morgantown, West Virginia, 26506
David Huss, MD, 304-293-7331, david.huss@hsc.wvu.edu
Margaret Jaynes, MD, 304-293-7331, mjaynes@hsc.wvu.edu
About this study
Official title: Talk With Me Baby: Leveraging Well-Child Care to Enhance the Early Home Language Environment for Rural and Underserved Children
The goal of this clinical trial is to learn if the Talk With Me Baby (TWMB) program improves the home-language environment for at-risk families with children ages two to six months when primary care providers deliver the program during well-child checkups. The main question it aims to answer is:
Will the TWMB program increase the time a caregiver talks to their infant?
Participants will:
- Come to at least four well-child checkups
- Receive the TWMB program from the provider during the checkups
- Record their conversations with their infant before they receive the program and after they receive the program four times.
- Conditions
- Language Development, Speech, Infant Development, Infant Behavior, Language, Child, Language
- Being tested
- Talk with Me Baby
- Medical subject headings
- Speech, Infant Behavior, Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Talk with Me BabyBehavioural
Primary care providers will embed Talk With Me Baby (TWMB) within standard-of-care Well-Child Care visits for children ≤36 months of age. Children will receive usual care plus a brief language-promotion intervention (TWMB) in up to 4 consecutive Well-Child Care visits during their 12-month period.
| Study group | Role | What they receive |
|---|---|---|
| Talk With Me Baby | Experimental | Not described Receives: Behavioral: Talk with Me Baby |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in the home-language-environment promotion behaviors, as measured by the Language Environment Analysis (LENA) Conversational Turn Count percentile score from Baseline to Post-Intervention
Measured: 12 months
Improvement in the home-language-environment promotion behaviors, as measured by the Language Environment Analysis (LENA) Adult Word Count percentile score from Baseline to Post-Intervention
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start3 Feb 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Language DevelopmentStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IDeA States Pediatric Clinical Trials Network
- Sponsor type
- Research network
- Collaborators
- National Institutes of Health (NIH), University of Kansas
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479278
- Sponsor's protocol ID
- 276453
- Other IDs
- U24OD024957
- Acronym
- TWMB
- Status last verified
- Jul 2025
- First submitted
- 18 Jun 2024
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Investigators will conduct this trial following the publication and data-sharing policies and regulations listed below: NIH Public Access Policy requires scientists to submit final peer-reviewed journal manuscripts arising from NIH funds to the digital archive PubMed Central upon acceptance for publication. Environmental Influences on Child Health Outcomes (ECHO) IDeA States Pediatric Clinical Trials Network (ISPCTN) Publications and Presentations Policy ensures the accurate, responsible, and efficient communication of findings from ECHO ISPCTN clinical trials. NIH Data Sharing Policy and the policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Resulting Information Submission Rule. Other researchers may request data from this trial by contacting Song Ounpraseuth, Ph.D., at the ISPCTN Data Coordinating and Operations Center (DCOC).
Publications
Salley B, Jaynes M, Huss D, Foster K, Hubberd D, Pohl K, Adkison S, Nader P, Baldner J, Greer M, Jin J, Fu LY, Abraham P, Ellerbeck EF. Study protocol for a pilot evaluation of Talk With Me Baby (TWMB) for Well-Child Care: A primary care-integrated language promotion intervention in rural and underserved clinics. PLoS One. 2026 Jul 24;21(7):e0353423. doi: 10.1371/journal.pone.0353423. eCollection 2026.
PubMed 42497176
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Talk With Me Baby: Leveraging Well-Child Care to Enhance the Early Home Language Environment for Rural and Underserved Children
- ClinicalTrials.gov ID
- NCT06479278
- Acronym / sponsor ID
- TWMB / 276453
- Conditions
- Language Development, Speech, Infant Development, Infant Behavior, Language, Child, Language
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- IDeA States Pediatric Clinical Trials NetworkResearch network
- Collaborators
- National Institutes of Health (NIH), University of Kansas
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 28 Jun 2024 (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.
The goal of this clinical trial is to learn if the Talk With Me Baby (TWMB) program improves the home-language environment for at-risk families with children ages two to six months when primary care providers deliver the program during well-child checkups. The main question it aims to answer is:
Will the TWMB program increase the time a caregiver talks to their infant?
Participants will:
- Come to at least four well-child checkups
- Receive the TWMB program from the provider during the checkups
- Record their conversations with their infant before they receive the program and after they receive the program four times.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Talk With Me Baby | Experimental | Behavioral: Talk with Me Baby |
Who may qualify
- Ages
- 0 to 9 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- A caregiver who will receive TWMB during routine WCC visits for their child at participating clinics, and
- The child of the above caregiver for whom the WCC visits are conducted.
- A potential caregiver participant must meet all the following inclusion criteria to enroll in the study:
- Be the age of majority, or older, as defined by the state of residency.
- Able to complete study measures in English.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Talk with Me BabyPrimary care providers will embed Talk With Me Baby (TWMB) within standard-of-care Well-Child Care visits for children ≤36 months of age. Children will receive usual care plus a brief language-promotion intervention (TWMB) in up to 4 consecutive Well-Child Care visits during their 12-month period. | Behavioural | Talk With Me Baby |
Primary outcome
Improvement in the home-language-environment promotion behaviors, as measured by the Language Environment Analysis (LENA) Conversational Turn Count percentile score from Baseline to Post-Intervention
Time frame: 12 months
Improvement in the home-language-environment promotion behaviors, as measured by the Language Environment Analysis (LENA) Adult Word Count percentile score from Baseline to Post-Intervention
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Derived from this study: PubMed 42497176Salley B, Jaynes M, Huss D, Foster K, Hubberd D, Pohl K, Adkison S, Nader P, Baldner J, Greer M, Jin J, Fu LY, Abraham P, Ellerbeck EF. Study protocol for a pilot evaluation of Talk With Me Baby (TWMB) for Well-Child Care: A primary care-integrated language promotion intervention in rural and underserved clinics. PLoS One. 2026 Jul 24;21(7):e0353423. doi: 10.1371/journal.pone.0353423. eCollection 2026.
- Individual participant dataSharing planned: Yes. Investigators will conduct this trial following the publication and data-sharing policies and regulations listed below: NIH Public Access Policy requires scientists to submit final peer-reviewed journal manuscripts arising from NIH funds to the digital archive PubMed Central upon acceptance for publication. Environmental Influences on Child Health Outcomes (ECHO) IDeA States Pediatric Clinical Trials Network (ISPCTN) Publications and Presentations Policy ensures the accurate, responsible, and efficient communication of findings from ECHO ISPCTN clinical trials. NIH Data Sharing Policy and the policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Resulting Information Submission Rule. Other researchers may request data from this trial by contacting Song Ounpraseuth, Ph.D., at the ISPCTN Data Coordinating and Operations Center (DCOC).
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Talk with Me Baby in people with Language Development and Speech, run by IDeA States Pediatric Clinical Trials Network at 2 sites 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 13 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Song Ounpraseuth, PhD (501-686-7233, STOunpraseuth@uams.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in the home-language-environment promotion behaviors, as measured by the Language Environment Analysis (LENA) Conversational Turn Count percentile score from Baseline to Post-Intervention (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06479278, which also lists 1 linked publication.
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 29 Aug 2025.