Child LanguageTWMBNCT07132411
Talk With Me Baby: Leveraging Well-Child Care to Enhance the Early Home Language Environment
A study testing Patients in Talk With Me Baby Clinics and Patients in Care-As-Usual Clinics in people with Child Language and Language Delay, run by University of Kansas Medical Center at 2 sites in United States.
Trial summary
Language-rich interactions with a parent or caregiver can serve as a protective factor for young children, by supporting their language development and other positive long-term outcomes, but existing interventions have not had the necessary reach to families who need this information the most. Read more about this study
- Who is it for?
- Ages 1 day to 2 years
- Conditions the study is for
- Child Language, Language Delay, Developmental Milestones
- What is being tested?
- Patients in Talk With Me Baby Clinics and Patients in Care-As-Usual Clinics
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Feb 2026to Jun 2029
- 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 1 day to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child must be enrolled prior to attending their 2-month WCC visit, age 1 month (+/- 30 days)
- Full term (>=37 weeks gestation)
- Singleton birth
- Home language of English and/or Spanish
- Child must receive WCC at a participating clinic
- A primary care practice (family medicine or pediatric model) that delivers WCC for children from 0-36 months old
- A minimum of 30% Medicaid/uninsured visits/year
- A minimum of 300 unique 0 to 36-month-old patients/year
Who cannot join
- Child with a severe congenital disorder that would affect neurodevelopmental outcomes, or hearing impairment that could affect participation
- Parent does not live with or spend >=2 days/week with the child
- Family does not plan to continue services at the clinic
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
- Not yet recruiting
Emory University
Atlanta, Georgia, 30322
Susan N Brasher, PhD, RN, CPNP, FAAN, 404-727-6490, susan.n.brasher@emory.edu
Susan N Brasher, PhD, RN, CPNP, FAAN
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Brenda J Salley, PhD, 913-945-7944, bsalley@kumc.edu
Megan Olalde, MS, RD, CCRP, 913-588-2042, molalde@kumc.edu
About this study
Language-rich interactions with a parent or caregiver can serve as a protective factor for young children, by supporting their language development and other positive long-term outcomes, but existing interventions have not had the necessary reach to families who need this information the most. This study utilizes the primary care setting as a low cost, scalable way to deliver language promotion intervention. Specifically, we will test the effectiveness and explore implementation of language promotion intervention (Talk With Me Baby) that embeds within anticipatory guidance during pediatric well-child care to boost early language development and optimize health, academic, and economic outcomes.
Read the detailed description
The quality of early language interactions with parents and caregivers in early childhood has long-term implications for a child's social, economic, and physical heath. Differences in the home language environment (HLE) are well established and cross all sociodemographic characteristics. Although several decades of research have identified evidence-based strategies that enhance the HLE and improve child outcomes, they have failed to reduce population-level differences in child language development and long-term outcomes. The study utilizes Talk With Me Baby (TWMB) as a novel tool to increase language building interactions between parent/caregiver and child. Because TWMB is delivered in the primary care setting (which reaches up to 98% of families with infants and toddlers), it is scalable, low-cost, and universal. With TWMB, healthcare providers can embed evidence-based language promotion into their well-child care (WCC) anticipatory guidance for all children age 0-3 years. TWMB builds on decades of well-controlled language intervention efficacy trials and has been deployed clinically for 8+ years. This study is a type 1 hybrid effectiveness implementation trial to measure the impact of TWMB on gains in the HLE and subsequent child language outcomes. The trial is both randomized and controlled across 2 sites: a TWMB intervention group (8 clinics) and a care-as-usual control group (8 clinics). In TWMB clinics, providers and care teams will be trained to deliver TWMB during all 2-24 month WCC visits. Across TWMB and control clinics, we will enroll 25 parent-child dyads in each clinic (n=400 total) prior to their 2-month WCC visit and follow them through their 24-month WCC visit.
- Conditions
- Child Language, Language Delay, Developmental Milestones
- Being tested
- Patients in Talk With Me Baby Clinics, Patients in Care-As-Usual Clinics
- Keywords
- well-child care, primary care practices, home language environment, preventative intervention, language development, language promotion intervention
- Medical subject headings
- Language Development Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients in Talk With Me Baby ClinicsBehavioural
Parent-child participants in TWMB clinics will attend their regular WCC visits (scheduled per routine clinic processes) following the AAP Periodicity Schedule.
Patients in Care-As-Usual ClinicsBehavioural
Parent-child participants in Care-As-Usual clinics will attend their regular WCC visits (scheduled per routine clinic processes) following the AAP Periodicity Schedule. Measures will be completed at five time points.
| Study group | Role | What they receive |
|---|---|---|
| Talk With Me Baby Clinics | Experimental | In TWMB clinics, TWMB will be delivered within usual WCC workflows for anticipatory guidance during the clinical encounter. TWMB is delivered by the primary clinician (i.e., pediatrician/family medicine physician; physician assistant; nurse practitioner) and/or a clinician and care team. TWMB targets key evidence-based language promotion strategies that previous research has shown to improve child language outcomes. TWMB training involves didactic and practice-based instruction (CME/CNE) that includes: (a) a brief review of the science behind why language promotion matters; (b) focused instruction (with video examples and modeling) on how to deliver components of TWMB, including the TWMB Checklist and Language Nutrition Prescription; and (c) live practice and role play with the trainer on delivering TWMB across child ages and families. Receives: Behavioral: Patients in Talk With Me Baby Clinics |
| Care-As-Usual Clinics | Active comparator | Providers/care teams will deliver care-as-usual WCC visits for all children. Parent-child participants in Control clinics will receive WCC anticipatory guidance care as usual. No treatment control is in line with the literature on randomized behavioral/educational interventions. Receives: Behavioral: Patients in Care-As-Usual Clinics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in parent language-promotion behavior
Change in parent language-promotion behavior (as measured by Language Environment Analysis [LENA] Conversational Turn Count) at each assessment time point (child age 1, 6, 12, and 18 months old) for parent-child dyads in TWMB clinics, compared to care-as-usual clinics.
Measured: Child age 1, 6, 12, and 18 months old
Child total language
Child language (as measured by the Preschool Language Scale-5 [PLS-5/PLS-5 Spanish] for Total Language) at child age 24 months old for parent-child dyads in TWMB clinics, compared to care-as-usual clinics.
Measured: Child age 24 months old
Child receptive language
Child receptive language (as measured by the Preschool Language Scale-5 [PLS-5/PLS-5 Spanish] for Receptive Language) at child age 24 months old for parent-child dyads in TWMB clinics, compared to care-as-usual clinics.
Measured: Child age 24 months old
Child expressive language
Child expressive language (as measured by the Preschool Language Scale-5 [PLS-5/PLS-5 Spanish] for Expressive Language) at child age 24 months old for parent-child dyads in TWMB clinics, compared to care-as-usual clinics.
Measured: Child age 24 months old
Secondary outcomes (9)
Change in parent language promotion knowledge
Parent language promotion knowledge (as measured using the Survey of Parent Expectations \& Knowledge [SPEAK] total score) at each child age 1, 12, and 24 months old for parent-child dyads in TWMB clinics, compared to care-as-usual clinics.
Measured: Child age 1, 12, and 24 months old
Change in Child vocalizations and verbalizations
Change in child vocalizations and verbalizations (as measured by Language Environment Analysis [LENA] Child Vocalization Count percentile scores) at child age 1, 6, 12, and 18 months old for children in TWMB clinics, compared to care-as-usual clinics.
Measured: Child age 1, 6, 12, and 18 months old
Change in child receptive vocabulary
Change in child receptive vocabulary (as measured by MacArthur-Bates Communicative Development Inventories [MBCDI] Short Form and Spanish Inventario Short Form I/II) at child age 12, 18, and 24 months for children in TWMB clinics, compared to care-as-usual clinics.
Measured: Child age 12, 18, and 24 months old
Change in child expressive vocabulary
Change in child expressive vocabulary (as measured by MacArthur-Bates Communicative Development Inventories [MBCDI] Short Form and Spanish Inventario Short Form I/II) at child age 12, 18, and 24 months for children in TWMB clinics, compared to care-as-usual clinics.
Measured: Child age 12, 18, and 24 months old
Parent contingent responding scores for a subset of the sample
Parent contingent responding scores (as measured by behavioral coding of home video recordings during daily routines) at child age 18 months for children in TWMB clinics, compared to care-as-usual clinics.
Measured: Child age 18 months old
Parent contingent verbal scaffolding scores for a subset of the sample
Parent verbal scaffolding scores (as measured by behavioral coding of home video recordings during daily routines) at child age 18 months for children in TWMB clinics, compared to care-as-usual clinics.
Measured: Child age 18 months old
Feasibility of intervention for treatment arm only
Feasibility of intervention (as assessed by the Feasibility of Intervention Measure [FIM]at post-intervention. The study team also plans to conduct interviews with the clinics with the highest and lowest FIM scores to identify facilitators and barriers to implementation.
Measured: Upon study completion, approximately 2 years
Acceptability of intervention for treatment arm only
Acceptability of intervention (as assessed by the Acceptability of Intervention Measure [AIM]) at post-intervention. The study team also plans to conduct interviews with the clinics with the highest and lowest AIM scores to identify facilitators and barriers to implementation.
Measured: Upon study completion, approximately 2 years
Appropriateness of intervention for treatment arm only
Appropriateness of intervention (as assessed by the Intervention Appropriateness Measure [IAM]) at post-intervention. The study team also plans to conduct interviews with the clinics with the highest and lowest IAM scores to identify facilitators and barriers to implementation.
Measured: Upon study completion, approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start5 Feb 2026
- Primary completionMar 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child LanguageStudies of the same condition, open and under way.
- More trials run by University of Kansas 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- A pragmatic type 1 hybrid effectiveness-implementation cluster randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Brenda J Salley, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07132411
- Sponsor's protocol ID
- STUDY00151172
- Other IDs
- 5R01HD112446-02
- Acronym
- TWMB
- Status last verified
- Mar 2026
- First submitted
- 2 Jul 2025
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. 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
- ClinicalTrials.gov ID
- NCT07132411
- Acronym / sponsor ID
- TWMB / STUDY00151172
- Conditions
- Child Language, Language Delay, Developmental Milestones
- Keywords
- well-child care, primary care practices, home language environment, preventative intervention, language development, language promotion intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 5 Feb 2026 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 20 Aug 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.
Language-rich interactions with a parent or caregiver can serve as a protective factor for young children, by supporting their language development and other positive long-term outcomes, but existing interventions have not had the necessary reach to families who need this information the most. This study utilizes the primary care setting as a low cost, scalable way to deliver language promotion intervention. Specifically, we will test the effectiveness and explore implementation of language promotion intervention (Talk With Me Baby) that embeds within anticipatory guidance during pediatric well-child care to boost early language development and optimize health, academic, and economic outcomes.
Detailed description
The quality of early language interactions with parents and caregivers in early childhood has long-term implications for a child's social, economic, and physical heath. Differences in the home language environment (HLE) are well established and cross all sociodemographic characteristics. Although several decades of research have identified evidence-based strategies that enhance the HLE and improve child outcomes, they have failed to reduce population-level differences in child language development and long-term outcomes. The study utilizes Talk With Me Baby (TWMB) as a novel tool to increase language building interactions between parent/caregiver and child. Because TWMB is delivered in the primary care setting (which reaches up to 98% of families with infants and toddlers), it is scalable, low-cost, and universal. With TWMB, healthcare providers can embed evidence-based language promotion into their well-child care (WCC) anticipatory guidance for all children age 0-3 years. TWMB builds on decades of well-controlled language intervention efficacy trials and has been deployed clinically for 8+ years. This study is a type 1 hybrid effectiveness implementation trial to measure the impact of TWMB on gains in the HLE and subsequent child language outcomes. The trial is both randomized and controlled across 2 sites: a TWMB intervention group (8 clinics) and a care-as-usual control group (8 clinics). In TWMB clinics, providers and care teams will be trained to deliver TWMB during all 2-24 month WCC visits. Across TWMB and control clinics, we will enroll 25 parent-child dyads in each clinic (n=400 total) prior to their 2-month WCC visit and follow them through their 24-month WCC visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A pragmatic type 1 hybrid effectiveness-implementation cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Talk With Me Baby Clinics | Experimental | Behavioral: Patients in Talk With Me Baby ClinicsIn TWMB clinics, TWMB will be delivered within usual WCC workflows for anticipatory guidance during the clinical encounter. TWMB is delivered by the primary clinician (i.e., pediatrician/family medicine physician; physician assistant; nurse practitioner) and/or a clinician and care team. TWMB targets key evidence-based language promotion strategies that previous research has shown to improve child language outcomes. TWMB training involves didactic and practice-based instruction (CME/CNE) that includes: (a) a brief review of the science behind why language promotion matters; (b) focused instruction (with video examples and modeling) on how to deliver components of TWMB, including the TWMB Checklist and Language Nutrition Prescription; and (c) live practice and role play with the trainer on delivering TWMB across child ages and families. |
| Care-As-Usual Clinics | Active comparator | Behavioral: Patients in Care-As-Usual ClinicsProviders/care teams will deliver care-as-usual WCC visits for all children. Parent-child participants in Control clinics will receive WCC anticipatory guidance care as usual. No treatment control is in line with the literature on randomized behavioral/educational interventions. |
Who may qualify
- Ages
- 1 day to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Child must be enrolled prior to attending their 2-month WCC visit, age 1 month (+/- 30 days)
- Full term (>=37 weeks gestation)
- Singleton birth
- Home language of English and/or Spanish
- Child must receive WCC at a participating clinic
Key exclusion criteria (3 listed)
- Child with a severe congenital disorder that would affect neurodevelopmental outcomes, or hearing impairment that could affect participation
- Parent does not live with or spend >=2 days/week with the child
- Family does not plan to continue services at the clinic
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 |
|---|---|---|
| Patients in Talk With Me Baby ClinicsParent-child participants in TWMB clinics will attend their regular WCC visits (scheduled per routine clinic processes) following the AAP Periodicity Schedule. | Behavioural | Talk With Me Baby Clinics |
| Patients in Care-As-Usual ClinicsParent-child participants in Care-As-Usual clinics will attend their regular WCC visits (scheduled per routine clinic processes) following the AAP Periodicity Schedule. Measures will be completed at five time points. | Behavioural | Care-As-Usual Clinics |
Primary outcome
Change in parent language-promotion behavior
Time frame: Child age 1, 6, 12, and 18 months old
Change in parent language-promotion behavior (as measured by Language Environment Analysis [LENA] Conversational Turn Count) at each assessment time point (child age 1, 6, 12, and 18 months old) for parent-child dyads in TWMB clinics, compared to care-as-usual clinics.
Child total language
Time frame: Child age 24 months old
Child language (as measured by the Preschool Language Scale-5 [PLS-5/PLS-5 Spanish] for Total Language) at child age 24 months old for parent-child dyads in TWMB clinics, compared to care-as-usual clinics.
Child receptive language
Time frame: Child age 24 months old
Child receptive language (as measured by the Preschool Language Scale-5 [PLS-5/PLS-5 Spanish] for Receptive Language) at child age 24 months old for parent-child dyads in TWMB clinics, compared to care-as-usual clinics.
Child expressive language
Time frame: Child age 24 months old
Child expressive language (as measured by the Preschool Language Scale-5 [PLS-5/PLS-5 Spanish] for Expressive Language) at child age 24 months old for parent-child dyads in TWMB clinics, compared to care-as-usual clinics.
9 secondary outcomes
Change in parent language promotion knowledge
Time frame: Child age 1, 12, and 24 months old
Change in Child vocalizations and verbalizations
Time frame: Child age 1, 6, 12, and 18 months old
Change in child receptive vocabulary
Time frame: Child age 12, 18, and 24 months old
Change in child expressive vocabulary
Time frame: Child age 12, 18, and 24 months old
Parent contingent responding scores for a subset of the sample
Time frame: Child age 18 months old
Parent contingent verbal scaffolding scores for a subset of the sample
Time frame: Child age 18 months old
Feasibility of intervention for treatment arm only
Time frame: Upon study completion, approximately 2 years
Acceptability of intervention for treatment arm only
Time frame: Upon study completion, approximately 2 years
Appropriateness of intervention for treatment arm only
Time frame: Upon study completion, approximately 2 years
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 24 Mar 2026.
- Individual participant dataSharing planned: Yes
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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.
Brenda J Salley, PhD principal investigator
University of Kansas Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients in Talk With Me Baby Clinics and Patients in Care-As-Usual Clinics in people with Child Language and Language Delay, run by University of Kansas Medical Center 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 8 inclusion and 3 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 24 Mar 2026. 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 Brenda J Salley, PhD (913-945-7944, bsalley@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in parent language-promotion behavior (time frame: Child age 1, 6, 12, and 18 months old). The study lists 4 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 24 Mar 2026.