An interventional study of Patients in Talk With Me Baby Clinics and Patients in Care-As-Usual Clinics in Child Language, Language Delay and Developmental Milestones, sponsored by University of Kansas Medical Center. Recruiting at 2 sites in United States. Open to participants aged 1 Day to 2 Years. Per ClinicalTrials.gov, last updated 2026-03-24.
Sponsored by University of Kansas Medical Center · Not applicable, Interventional, and Treatment
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.
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.
121 studies on the registry are indexed under Language Development Disorders; 49 are open to participants now.
This study's planned enrollment of 400 is above the median of 74 across 106 interventional studies indexed under Language Development Disorders.
Browse Language Development Disorders studies →University of Kansas Medical Center is the lead sponsor of 492 studies on the registry; 110 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria for Participants:
Exclusion Criteria for Participants:
Inclusion Criteria for Clinics:
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.
Behavioral: Patients in Talk With Me Baby Clinics
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.
Behavioral: Patients in Care-As-Usual Clinics
Parent-child participants in TWMB clinics will attend their regular WCC visits (scheduled per routine clinic processes) following the AAP Periodicity Schedule.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Child age 24 months old
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Upon study completion, approximately 2 years
Moderator: Family strengths and parent resources
Family strengths and parent resources (as measured using the Healthy Families Parenting Inventory (HFPI) total score) at baseline.
Time frame: Child age 1 month old
Mediator: Parent language promotion knowledge
Parent language promotion knowledge (as measured using the Survey of Parent Expectations \& Knowledge \[SPEAK\] total score) at baseline.
Time frame: Child age 1 month old
Mediator: Home language environment for child outcomes
Home language environment (HLE) as measured using Conversational Turns \[CT percentile score\] at each child age 1, 6, 12, and 18 months old.
Time frame: Child age 1, 6, 12, and 18 months old
Mediator: Dosage of parent input for child outcomes
Dosage of parent language input as measured using LENA Adult Word Count \[AWC percentile score\] at each child age 1, 6, 12, and 18 months old.
Time frame: Child age 1, 6, 12, and 18 months old
Plan to share: Yes
Supporting information: Study protocol
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