Safe Sleep EducationNCT02010450
Re-enforcing Safe Sleep Practices for Caregivers With Tangible Incentives
A study testing Wearable Blanket (Sleep Sack) and Incentive Item in people with Safe Sleep Education, run by University of Kansas at 1 site in United States.
Trial summary
This study is a pilot study to test the effectiveness of incentive items to increase compliance of infant safe sleep practices among caregivers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Safe Sleep Education
- What is being tested?
- Wearable Blanket (Sleep Sack) and Incentive Item
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parent of 1-month old baby
- Over the age of 18
- Be able to speak and read English
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Re-enforcing Safe Sleep Practices for Caregivers With Tangible Incentives: Pilot Testing of the MSSC Physician Safe Sleep Taskforce Caregiver Incentive Toolkit
This study is a pilot study to test the effectiveness of incentive items to increase compliance of infant safe sleep practices among caregivers.
- Conditions
- Safe Sleep Education
- Being tested
- Wearable Blanket (Sleep Sack), Incentive Item
- Keywords
- Sudden Infant Death Syndrome, SIDS, safe sleep, safe sleep message
- Medical subject headings
- Sudden Infant Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable Blanket (Sleep Sack)Other
Incentive ItemOther
| Study group | Role | What they receive |
|---|---|---|
| Wearable Blanket | Experimental | subjects randomized to this group will receive a wearable blanket (sleep sack) that contains a safe sleep message. Receives: 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. Receives: Other: Incentive Item |
What is being measured
The primary outcome is the main question the study is designed to answer.
dichotomous sleep variable (safe vs unsafe)
change measured using "safe sleep quiz" questionnaire
Measured: Change from Baseline to 2 Months
Secondary outcomes (1)
determine which incentive item provided is most effective in reinforcing the safe sleep message
determination to be assessed using questionnaire completed by caregiver
Measured: Change from Baseline to 2 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safe Sleep EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carolyn R Ahlers-Schmidt, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02010450
- Sponsor's protocol ID
- 13-017
- Status last verified
- Apr 2015
- First submitted
- 9 Dec 2013
- Last updated
- 16 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Re-enforcing Safe Sleep Practices for Caregivers With Tangible Incentives: Pilot Testing of the MSSC Physician Safe Sleep Taskforce Caregiver Incentive Toolkit
- ClinicalTrials.gov ID
- NCT02010450
- Acronym / sponsor ID
- 13-017
- Conditions
- Safe Sleep Education
- Keywords
- Sudden Infant Death Syndrome, SIDS, safe sleep, safe sleep message
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- University of KansasUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 12 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a pilot study to test the effectiveness of incentive items to increase compliance of infant safe sleep practices among caregivers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wearable Blanket | Experimental | Other: Wearable Blanket (Sleep Sack)subjects randomized to this group will receive a wearable blanket (sleep sack) that contains a safe sleep message. |
| Control Group | Active comparator | Other: Incentive Itemsubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Parent of 1-month old baby
- Over the age of 18
- Be able to speak and read English
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable Blanket (Sleep Sack) | Other | Wearable Blanket |
| Incentive Item | Other | Control Group |
Primary outcome
dichotomous sleep variable (safe vs unsafe)
Time frame: Change from Baseline to 2 Months
change measured using "safe sleep quiz" questionnaire
1 secondary outcome
determine which incentive item provided is most effective in reinforcing the safe sleep message
Time frame: Change from Baseline to 2 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2015.
Related trials for Safe Sleep Education
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Social Media and Risk-reduction Training for Preterm Infant Care Practices
Safe Sleep Education, SUID
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The Impact of the Nurse-Led "My Baby is Safe" Educational Program
Sudden Infant Death Syndrome, Shaken Baby Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolyn R Ahlers-Schmidt, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable Blanket (Sleep Sack) and Incentive Item in people with Safe Sleep Education, run by University of Kansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dichotomous sleep variable (safe vs unsafe) (time frame: Change from Baseline to 2 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2015.