Talk With Me Baby to Enhance the Early Home Language Environment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-03

Study Completion Date

2026-08-31

Brief Summary

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The goal of this clinical trial is to learn if the Talk With Me Baby (TWMB) program improves the home-language environment for at-risk families with children ages two to six months when primary care providers deliver the program during well-child checkups. The main question it aims to answer is:

Will the TWMB program increase the time a caregiver talks to their infant?

Participants will:

1. Come to at least four well-child checkups
2. Receive the TWMB program from the provider during the checkups
3. Record their conversations with their infant before they receive the program and after they receive the program four times.

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Detailed Description

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Conditions

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Language Development Speech Infant Development Infant Behavior Language, Child Language

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Talk With Me Baby

Group Type EXPERIMENTAL

Talk with Me Baby

Intervention Type BEHAVIORAL

Primary care providers will embed Talk With Me Baby (TWMB) within standard-of-care Well-Child Care visits for children ≤36 months of age. Children will receive usual care plus a brief language-promotion intervention (TWMB) in up to 4 consecutive Well-Child Care visits during their 12-month period.

Interventions

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Talk with Me Baby

Primary care providers will embed Talk With Me Baby (TWMB) within standard-of-care Well-Child Care visits for children ≤36 months of age. Children will receive usual care plus a brief language-promotion intervention (TWMB) in up to 4 consecutive Well-Child Care visits during their 12-month period.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

For this study, each child-caregiver dyad will consist of:

1. A caregiver who will receive TWMB during routine WCC visits for their child at participating clinics, and
2. The child of the above caregiver for whom the WCC visits are conducted.

1. Be the age of majority, or older, as defined by the state of residency.
2. Able to complete study measures in English.
3. Have the legal authority to consent to participate for themselves and to consent on behalf of their child.

To proceed to the follow-up portion of the study the caregiver (dyad) must have a LENA baseline assessment score that is ≤ 75th percentile compared to a child's age-referenced normative data.

1. Receive WCC at a participating clinic from a participating provider.
2. Be zero to nine months (+ 0-30 days) old at enrollment.
3. Was born at full term (\> 37 weeks gestation).
4. Was born in a singleton birth (i.e., was the only child delivered during the birth).

Minimum Eligible Age

0 Months

Maximum Eligible Age

9 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes