- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02052843
Impact Evaluation of the Steps to Success Program
April 13, 2017 updated by: Mathematica Policy Research, Inc.
The evaluation will examine whether the Steps to Success enhanced home visits are more effective at delaying repeat pregnancies than are traditional Healthy Families home visits.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
595
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
San Angelo, Texas, United States, 76903
- Healthy Families San Angelo
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 21 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female
- Age 14 to 21
- Pregnant, or have delivered a child in the last three months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Steps to Success
Steps to Success enhanced home visits-including instruction for both young mothers and fathers on contraception, comprehensive sex education, and the importance of adequate birth spacing, and accompanied by group sessions on adulthood preparation topics.
|
|
|
Active Comparator: Traditional Healthy Families
Traditional Healthy Families home visits which cover topics of parenting and child development
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Subsequent pregnancy
Time Frame: 2-years post random assignment
|
2-years post random assignment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Subsequent pregnancy
Time Frame: 1-year post random assignment
|
1-year post random assignment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Robert Wood, p, Mathematica Policy Research
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2013
Primary Completion (Anticipated)
June 1, 2018
Study Completion (Anticipated)
June 1, 2018
Study Registration Dates
First Submitted
January 30, 2014
First Submitted That Met QC Criteria
January 30, 2014
First Posted (Estimate)
February 3, 2014
Study Record Updates
Last Update Posted (Actual)
April 17, 2017
Last Update Submitted That Met QC Criteria
April 13, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- PRP699103
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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