Talk With Me Baby: Leveraging Well-Child Care to Enhance the Early Home Language Environment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-2
SponsorUniversity of Kansas Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
A primary care practice (family medicine or pediatric model) that delivers WCC for children from 0-36 months old
Trial design
Design model
Parallel
Treatments tested in this trial
Patients in Talk With Me Baby Clinics
BehavioralParent-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 Clinics
BehavioralParent-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.
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Talk With Me Baby ClinicsExperimental treatment 1 intervention
Group B: Care-As-Usual ClinicsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 old2
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 old3
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 old4
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 oldSecondary outcomes
1
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 old2
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 old3
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 old4
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 oldOther outcomes
1
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 old2
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 old3
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 old4
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 oldSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Kansas Medical Center
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov