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Generations in Families Talking Safe Sleep

NCT03186469 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2019-07-18

No results posted yet for this study

Summary

Teen mothers present a unique set of challenges in reducing the risk for sleep-related infant mortality, in part because they may not be the sole decision-maker for an infant's sleep environment and position and they make seek advice from older female support people. Investigators will conduct a randomized controlled trial of a educational intervention to mitigate the risks of unsafe infant sleep practices across generations. Given the complexity and variability of teen-SCG relationships, investigators will include an examination of inter- and intra-personal factors that are key control variables or may mediate the uptake of safe sleep recommendations. Investigators believe that the intervention will empower support people to positively influence a teen mother's adoption of safe sleep recommendations.

Conditions

  • Sudden Infant Death

Interventions

BEHAVIORAL

Safety Baby shower

A Safety Baby Shower using didactic and experiential teaching methods to educate participants on safety topics focused on reducing infant mortality. Participants receive safety products as their "shower gifts" with education on appropriate use of the products. The relaxed setting also encourages participants to seek answers and clarify myths from credible sources not otherwise available among family and friends. For intervention provides information on the infant's sleep position, bedding, co-sleeping, and tobacco exposure, all of which, alone or in combination, are risk factors for sleep-related deaths in infants. Breastfeeding, a protective factor for SIDS, will be encouraged.

BEHAVIORAL

Standard of Care

Participants will received standard of care in regards to infant injury prevention. Written material on car seat safety, prevention of abusive head trauma, and safe sleep environments will be provide to participants.

Sponsors & Collaborators

  • Arkansas Children's Hospital Research Institute

    lead OTHER

Principal Investigators

  • Mary E Aitken, MD, MPH · Arkansas Children's Hospital Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
13 Years
Max Age
19 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-07
Primary Completion
2020-04-30
Completion
2020-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03186469 on ClinicalTrials.gov