Talk With Me Baby: Leveraging Well-Child Care to Enhance the Early Home Language Environment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Change in parent language-promotion behavior
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Talk With Me Baby 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.
干预措施: Patients in Talk With Me Baby Clinics (Behavioral)
Care-As-Usual 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.
干预措施: Patients in Care-As-Usual Clinics (Behavioral)
结局指标
主要结局
Change in parent language-promotion behavior
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Parent contingent verbal scaffolding scores for a subset of the sample(Child age 18 months old)
- Acceptability of intervention for treatment arm only(Upon study completion, approximately 2 years)
- Change in child receptive vocabulary(Child age 12, 18, and 24 months old)
- Change in parent language promotion knowledge(Child age 1, 12, and 24 months old)
- Change in Child vocalizations and verbalizations(Child age 1, 6, 12, and 18 months old)
- Change in child expressive vocabulary(Child age 12, 18, and 24 months old)
- Parent contingent responding scores for a subset of the sample(Child age 18 months old)
- Feasibility of intervention for treatment arm only(Upon study completion, approximately 2 years)
- Appropriateness of intervention for treatment arm only(Upon study completion, approximately 2 years)