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Behavioral Intervention

Talk With Me Baby for Infant Language Development (TWMB Trial)

N/A
Waitlist Available
Research Sponsored by IDeA States Pediatric Clinical Trials Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Child must receive WCC at a participating clinic from a participating provider, be two to six months old at enrollment, born at full term (> 37 weeks gestation), and born in a singleton birth
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to see if the Talk With Me Baby program can improve how much caregivers talk to their infants in at-risk families with children aged two to six months. Caregivers will attend four well

Who is the study for?
This trial is for families with children aged 2-6 months who may be at risk of language development issues. Caregivers must commit to attending at least four well-child checkups and recording their conversations with their infant before and after receiving the TWMB program.
What is being tested?
The study tests if the 'Talk With Me Baby' (TWMB) program, given by primary care providers during regular checkups, can increase how much caregivers talk to their infants, potentially enhancing language development in early childhood.
What are the potential side effects?
There are no medical side effects associated with this intervention as it involves educational guidance rather than medication or clinical treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My child is 2-6 months old, born full-term and not part of a multiple birth, and sees a doctor at a participating clinic.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Talk With Me BabyExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

University of KansasOTHER
152 Previous Clinical Trials
331,669 Total Patients Enrolled
IDeA States Pediatric Clinical Trials NetworkLead Sponsor
6 Previous Clinical Trials
1,191 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,810 Previous Clinical Trials
8,159,566 Total Patients Enrolled
3 Trials studying Infant Development
497 Patients Enrolled for Infant Development
~44 spots leftby Jun 2026
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