Re-enforcing Safe Sleep Practices for Caregivers With Tangible Incentives

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Kansas Medical Center
ClinicalTrials.gov Identifier:
NCT02010450
First received: December 9, 2013
Last updated: April 15, 2015
Last verified: April 2015
  Purpose
This study is a pilot study to test the effectiveness of incentive items to increase compliance of infant safe sleep practices among caregivers.

Condition Intervention
Safe Sleep Education
Other: Wearable Blanket (Sleep Sack)
Other: Incentive Item

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Re-enforcing Safe Sleep Practices for Caregivers With Tangible Incentives: Pilot Testing of the MSSC Physician Safe Sleep Taskforce Caregiver Incentive Toolkit

Resource links provided by NLM:


Further study details as provided by University of Kansas Medical Center:

Primary Outcome Measures:
  • dichotomous sleep variable (safe vs unsafe) [ Time Frame: Change from Baseline to 2 Months ] [ Designated as safety issue: No ]
    change measured using "safe sleep quiz" questionnaire


Secondary Outcome Measures:
  • determine which incentive item provided is most effective in reinforcing the safe sleep message [ Time Frame: Change from Baseline to 2 Months ] [ Designated as safety issue: No ]
    determination to be assessed using questionnaire completed by caregiver


Enrollment: 152
Study Start Date: October 2013
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Wearable Blanket
subjects randomized to this group will receive a wearable blanket (sleep sack) that contains a safe sleep message.
Other: Wearable Blanket (Sleep Sack)
Active Comparator: Control Group
subjects randomized to this group will receive an incentive item (such as a University of Kansas Pediatrics water Bottle) that does not contain the safe sleep message.
Other: Incentive Item

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Parent of 1-month old baby
  • Over the age of 18
  • Be able to speak and read English

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02010450

Locations
United States, Kansas
KU Wichita Pediatrics
Wichita, Kansas, United States, 67214
Sponsors and Collaborators
University of Kansas Medical Center
Investigators
Principal Investigator: Carolyn R Ahlers-Schmidt, PhD University of Kansas Medical Center
  More Information

Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT02010450     History of Changes
Other Study ID Numbers: 13-017 
Study First Received: December 9, 2013
Last Updated: April 15, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas Medical Center:
Sudden Infant Death Syndrome
SIDS
safe sleep
safe sleep message

ClinicalTrials.gov processed this record on July 27, 2016