Trial record 19 of 35 for:    SIDS

Re-enforcing Safe Sleep Practices for Caregivers With Tangible Incentives

This study is currently recruiting participants.
Verified December 2013 by University of Kansas
Sponsor:
Information provided by (Responsible Party):
University of Kansas
ClinicalTrials.gov Identifier:
NCT02010450
First received: December 9, 2013
Last updated: NA
Last verified: December 2013
History: No changes posted
  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:

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


Estimated Enrollment: 184
Study Start Date: October 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT02010450

Contacts
Contact: Carolyn R Ahlers-Schmidt, PhD 316-293-1810 cschmidt3@kumc.edu

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

No publications provided

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

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

ClinicalTrials.gov processed this record on April 20, 2014