NCT02010450

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 12, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

April 16, 2015

Status Verified

April 1, 2015

Enrollment Period

1.1 years

First QC Date

December 9, 2013

Last Update Submit

April 15, 2015

Conditions

Safe Sleep Education

Keywords

Sudden Infant Death SyndromeSIDSsafe sleepsafe sleep message

Outcome Measures

Primary Outcomes (1)

  • dichotomous sleep variable (safe vs unsafe)

    change measured using "safe sleep quiz" questionnaire

    Change from Baseline to 2 Months

Secondary Outcomes (1)

  • determine which incentive item provided is most effective in reinforcing the safe sleep message

    Change from Baseline to 2 Months

Study Arms (2)

Wearable Blanket

EXPERIMENTAL

subjects randomized to this group will receive a wearable blanket (sleep sack) that contains a safe sleep message.

Other: Wearable Blanket (Sleep Sack)

Control Group

ACTIVE COMPARATOR

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

Interventions

Wearable Blanket (Sleep Sack)OTHER
Wearable Blanket
Incentive ItemOTHER
Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KU Wichita Pediatrics

Wichita, Kansas, 67214, United States

Location

MeSH Terms

Conditions

Sudden Infant Death

Condition Hierarchy (Ancestors)

Death, SuddenDeathPathologic ProcessesPathological Conditions, Signs and SymptomsInfant Death

Study Officials

  • Carolyn R Ahlers-Schmidt, PhD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2013

First Posted

December 12, 2013

Study Start

October 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

April 16, 2015

Record last verified: 2015-04

Locations

US(1)