Enhancing Safe Sleep Practices of Urban Low-Income Mothers
|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: NCT03070639|
Recruitment Status : Completed
First Posted : March 3, 2017
Last Update Posted : August 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Sudden Infant Death Syndrome||Behavioral: Safe Sleep Intervention Behavioral: Scald Prevention Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||214 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Enhancing Safe Sleep Practices of Urban Low-Income Mothers|
|Actual Study Start Date :||October 2015|
|Actual Primary Completion Date :||April 2017|
|Actual Study Completion Date :||June 2017|
No Intervention: Standard Care Study Condition
The Standard of Care control group will not receive any additional services at the newborn visit.
Active Comparator: Attention-Matched Control Condition
The Attention-Matched Control Condition will include the Scald Prevention Intervention.
Behavioral: Scald Prevention Intervention
A health educator will visit participant during their 2-week well visit in the clinic, to deliver a tailored intervention based on practices regarding scald risks in the home. Participant will also receive a bath thermometer, candy/frying thermometer, and educational resources on scald prevention.
Experimental: Safe Sleep Intervention Condition
The Intervention Condition will include the Safe Sleep Intervention.
Behavioral: Safe Sleep Intervention
A health educator will visit participant during their 2-week well visit in the clinic, to deliver a tailored intervention based on the baby's sleep practices. Participant will also receive a free pack'n play, sleep sack, and educational resources on safe sleep.
- Evaluate the Effect of a Safe Sleep Intervention on the Safe Sleep Environment of Infants [ Time Frame: Follow-up #1 (3-6 weeks) ]Assessed with a 125-item questionnaire.
- Evaluate the Effect of a Scald Prevention Intervention on Potential Scald Risks in the Home [ Time Frame: Follow-up #1 (3-6 weeks) ]Assessed with a 45-item questionnaire.
- Describe Characteristics of Physician Anticipatory Guidance on Safe Sleep and Other Safety Topics [ Time Frame: 2-week well-child visit and 2-month well-child visit ]Assessed with an 11-item coding sheet and transcription file.
- Evaluate Dissemination of City Health Department's Safe Sleep Campaign Messages and Services Among Participants [ Time Frame: Baseline survey (2 weeks) ]Assessed with a 13-item questionnaire.
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): NCT03070639
|United States, Maryland|
|Harriet Lane Clinic|
|Baltimore, Maryland, United States, 21205|
|Principal Investigator:||Andrea C Gielen, ScD, ScM||Johns Hopkins Bloomberg School of Public Health|