RECRUITING

Talk With Me Baby to Enhance the Early Home Language Environment

Conditions

Language Development Speech Infant Development Infant Behavior Language, Child Language

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Talk With Me Baby: Leveraging Well-Child Care to Enhance the Early Home Language Environment for Rural and Underserved Children

Quick Facts

Study Start:2025-02-03

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06479278

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Months to 6 Months

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
1. A caregiver who will receive TWMB during routine well-childcare checkups (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. 1. Receive WCC at a participating clinic from a participating provider. 2. Be two to six 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).	1. Has a cognitive impairment or a visual or hearing impairment known to the clinic that limits their ability to make decisions about participating or engaging with the assessments, based on the site primary investigator's (PI's) assessment and local human subjects' research policies. 2. Does not live with child or spend at least two full days (i.e., at least 48 hours) per week with the child. 3. Does not plan for the child to continue receiving services at the participating clinic for at least 12 months. 1. Significant developmental delay or cognitive, visual, or hearing impairment known to the clinic. 2. Previously attended WCC visit prior to enrollment that occurred during the TWMB trial.

Inclusion Criteria

Exclusion Criteria

1. A caregiver who will receive TWMB during routine well-childcare checkups (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.
1. Receive WCC at a participating clinic from a participating provider.
2. Be two to six 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).

1. Has a cognitive impairment or a visual or hearing impairment known to the clinic that limits their ability to make decisions about participating or engaging with the assessments, based on the site primary investigator's (PI's) assessment and local human subjects' research policies.
2. Does not live with child or spend at least two full days (i.e., at least 48 hours) per week with the child.
3. Does not plan for the child to continue receiving services at the participating clinic for at least 12 months.
1. Significant developmental delay or cognitive, visual, or hearing impairment known to the clinic.
2. Previously attended WCC visit prior to enrollment that occurred during the TWMB trial.

Contacts and Locations

Study Contact

Song Ounpraseuth, PhD

CONTACT

501-686-7233

STOunpraseuth@uams.edu

DeAnn E Hubberd, MA

CONTACT

501-686-5547

dehubberd@uams.edu

Study Locations (Sites)

Kansas University Medical Center

Kansas City, Kansas, 66160

United States

West Virginia University

Morgantown, West Virginia, 26506

United States

Collaborators and Investigators

Sponsor: IDeA States Pediatric Clinical Trials Network

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-03

Study Completion Date2026-12

Study Record Updates

Study Start Date2025-02-03

Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

Language Development
Speech
Infant Development
Infant Behavior
Language, Child
Language