Child Language, Developmental Milestones, Language Delay
Conditions
Keywords
well-child care, primary care practices, home language environment, preventative intervention, language development, language promotion intervention
Brief 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. 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.
Interventions
BEHAVIORALPatients in Talk With Me Baby Clinics
Parent-child participants in TWMB clinics will attend their regular WCC visits (scheduled per routine clinic processes) following the AAP Periodicity Schedule.
BEHAVIORALPatients in Care-As-Usual Clinics
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.
Sponsors
University of Kansas Medical Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A pragmatic type 1 hybrid effectiveness-implementation cluster randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
1 Days to 2 Years
Healthy volunteers
No
Inclusion criteria
for Participants: * 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
Exclusion criteria
for Participants: * 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 Inclusion Criteria for Clinics: * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in parent language-promotion behavior | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in parent language promotion knowledge | Child age 1, 12, and 24 months old | 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. |
| Change in Child vocalizations and verbalizations | Child age 1, 6, 12, and 18 months old | 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. |
| Change in child receptive vocabulary | Child age 12, 18, and 24 months old | 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. |
| Change in child expressive vocabulary | Child age 12, 18, and 24 months old | 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. |
| Parent contingent responding scores for a subset of the sample | Child age 18 months old | 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. |
| Parent contingent verbal scaffolding scores for a subset of the sample | Child age 18 months old | 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. |
| Feasibility of intervention for treatment arm only | Upon study completion, approximately 2 years | 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. |
| Acceptability of intervention for treatment arm only | Upon study completion, approximately 2 years | 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. |
| Appropriateness of intervention for treatment arm only | Upon study completion, approximately 2 years | 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. |
Countries
United States
Contacts
CONTACTBrenda J Salley, PhD
PRINCIPAL_INVESTIGATORBrenda J Salley, PhD
University of Kansas Medical Center
Outcome results
None listed