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Re-enforcing Safe Sleep Practices for Caregivers With Tangible Incentives

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02010450
Recruitment Status : Completed
First Posted : December 12, 2013
Last Update Posted : April 16, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study is a pilot study to test the effectiveness of incentive items to increase compliance of infant safe sleep practices among caregivers.

Condition or disease Intervention/treatment
Safe Sleep Education Other: Wearable Blanket (Sleep Sack) Other: Incentive Item

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2013
Primary Completion Date : November 2014
Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. dichotomous sleep variable (safe vs unsafe) [ Time Frame: Change from Baseline to 2 Months ]
    change measured using "safe sleep quiz" questionnaire


Secondary Outcome Measures :
  1. determine which incentive item provided is most effective in reinforcing the safe sleep message [ Time Frame: Change from Baseline to 2 Months ]
    determination to be assessed using questionnaire completed by caregiver


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02010450


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

Responsible Party: University of Kansas
ClinicalTrials.gov Identifier: NCT02010450     History of Changes
Other Study ID Numbers: 13-017
First Posted: December 12, 2013    Key Record Dates
Last Update Posted: April 16, 2015
Last Verified: April 2015

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