Talk With Me Baby for Child Development

(TWMB Trial)

Not yet recruiting at 1 trial location
BJ
Overseen ByBrenda J Salley, PhD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of Kansas Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to boost early language development in young children through language-rich interactions with parents or caregivers. It will test a language promotion program called "Talk With Me Baby" during regular pediatric check-ups. The trial will compare this program with standard care to determine its impact on child language outcomes. Families who speak English or Spanish at home and visit participating clinics for well-child care may be a good fit, especially if their child is full-term and has no severe congenital disorders.

As an unphased trial, this study offers families the opportunity to contribute to valuable research that could enhance early childhood language development.

Do I need to stop my current medications to participate in the trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on language development interventions for young children, so it's unlikely that adult medications would be affected.

What prior data suggests that the "Talk With Me Baby" intervention is safe for child development?

Research has shown that the "Talk With Me Baby" program enhances children's language skills by encouraging parents to engage in more language-rich conversations. This educational program focuses on teaching parents how to communicate more effectively with their children.

As a non-invasive educational program, it has no reports of physical side effects. Participants have received it well because it provides training and guidance to help caregivers improve their communication skills. Studies have found that these interactions can positively affect children's brain development, with no known risks to participants.

The trial is labeled "Not Applicable" for phase, indicating it is not a traditional drug or medical treatment but an educational approach. This classification suggests there are no safety concerns like those in pharmaceutical trials.12345

Why are researchers excited about this trial?

Researchers are excited about the "Talk With Me Baby" program because it takes a unique approach to boosting child language development by integrating language promotion directly into regular wellness checkups. Unlike traditional methods that might focus on more general parental guidance, this program provides hands-on training for healthcare providers, enabling them to offer specific, evidence-based strategies tailored to language development. This personalized interaction, combined with practical tools like the TWMB Checklist and Language Nutrition Prescription, could lead to significant improvements in language skills among children, setting it apart from standard care practices.

What evidence suggests that the "Talk With Me Baby" intervention is effective for child language development?

Research has shown that the "Talk With Me Baby" program, which participants in this trial may receive, effectively supports children's language development. Studies have found that babies who hear more speech directed at them understand words better and have larger vocabularies by age 2. The program teaches techniques such as using a sing-song voice, asking questions, and giving positive feedback, all of which help improve language skills. Evidence strongly supports the program's success and suggests it enhances children's language abilities. In this trial, the program will integrate into regular pediatric visits in the "Talk With Me Baby Clinics" arm, providing an easy way to boost early language development.23678

Who Is on the Research Team?

BJ

Brenda J Salley, PhD

Principal Investigator

University of Kansas Medical Center

Are You a Good Fit for This Trial?

This trial is for young children experiencing speech delays or language disorders. It aims to help families who could benefit from guidance on enhancing language development through regular interactions with their child.

Inclusion Criteria

* Child must be enrolled prior to attending their 2-month WCC visit, age 1 month (+/- 30 days)
* Full term (\>=37 weeks gestation)
* Singleton birth
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Talk With Me Baby intervention is delivered during well-child care visits to promote language development

22 months
Regular well-child care visits from 2 to 24 months

Follow-up

Participants are monitored for language development outcomes and intervention effectiveness

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Talk With Me Baby
Trial Overview The study tests a new approach called 'Talk With Me Baby,' which integrates language promotion into pediatric well-child care, versus the usual care practices. The goal is to see if this can improve early language skills and future health and academic success.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Talk With Me Baby ClinicsExperimental Treatment1 Intervention
Group II: Care-As-Usual ClinicsActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials
527
Recruited
181,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials
2,103
Recruited
2,760,000+

Citations

Talk with Me Baby: Early Language Knowledge Across ...Results reveal an overwhelming support for TWMB with high perceived reach, effectiveness, adoption, implementation, and maintenance, bolstering ...
Talking to children matters: Early language experience ...Infants who experienced more child-directed speech became more efficient in processing familiar words in real time and had larger expressive vocabularies by 24 ...
Talk with Me Baby: Early Language Knowledge Across ...Results reveal an overwhelming support for TWMB with high perceived reach, effectiveness, adoption, implementation, and maintenance, bolstering ...
Embedding Universal Language Promotion in Pediatric ...Talk With Me Baby targets 3 key evidence-based language promotion strategies that previous research has shown to improve child language outcomes:14,15,27 (1) ...
Talk With Me Baby – Empowering Parents to Support ...Using Parentese, Serve and Return, Questions, Loving Words and Positive Affirmations are great strategies to promote language learning. Babies' brains are ...
Talk With Me Baby to Enhance the Early Home Language ...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 ...
Talking to babies may help shape brain structure, research ...The amount of adult speech children are exposed to in their early years may help to shape the structure of their brains, researchers say.
Study Details | Talk With Me Baby: Leveraging Well-Child ...Also called a data safety and monitoring board, or DSMB. Early Phase 1 (formerly listed as Phase 0). A phase of research used to describe exploratory trials ...
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