PregnancyNCT02052843
Impact Evaluation of the Steps to Success Program
A study testing Steps to Success and Traditional Healthy Families in people with Pregnancy, run by Mathematica Policy Research, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 21 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Steps to Success and Traditional Healthy Families
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 595 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Jun 2018
- 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 14 to 21 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Female
- Age 14 to 21
- Pregnant, or have delivered a child in the last three months
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Healthy Families San Angelo
San Angelo, Texas, 76903
About this study
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.
- Conditions
- Pregnancy
- Being tested
- Steps to Success, Traditional Healthy Families
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Steps to SuccessBehavioural
Traditional Healthy FamiliesBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Steps to Success | Experimental | 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. Receives: Behavioral: Steps to Success |
| Traditional Healthy Families | Active comparator | Traditional Healthy Families home visits which cover topics of parenting and child development Receives: Behavioral: Traditional Healthy Families |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subsequent pregnancy
Measured: 2-years post random assignment
Secondary outcomes (1)
Subsequent pregnancy
Measured: 1-year post random assignment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2014 (estimated)
- Study startMay 2013
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- 595 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mathematica Policy Research, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Wood, p, Study director, Mathematica Policy Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02052843
- Sponsor's protocol ID
- PRP699103
- Status last verified
- Apr 2017
- First submitted
- 30 Jan 2014
- Last updated
- 17 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Evaluation of the Steps to Success Program
- ClinicalTrials.gov ID
- NCT02052843
- Acronym / sponsor ID
- PRP699103
- Conditions
- Pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 595 participants (actual)
- Lead sponsor
- Mathematica Policy Research, Inc.University, hospital or other
- Study start
- May 2013 (actual)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 3 Feb 2014 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Steps to Success | Experimental | Behavioral: Steps to SuccessSteps 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. |
| Traditional Healthy Families | Active comparator | Behavioral: Traditional Healthy FamiliesTraditional Healthy Families home visits which cover topics of parenting and child development |
Who may qualify
- Ages
- 14 to 21 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Female
- Age 14 to 21
- Pregnant, or have delivered a child in the last three months
Key exclusion criteria (0 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 |
|---|---|---|
| Steps to Success | Behavioural | Steps to Success |
| Traditional Healthy Families | Behavioural | Traditional Healthy Families |
Primary outcome
Subsequent pregnancy
Time frame: 2-years post random assignment
1 secondary outcome
Subsequent pregnancy
Time frame: 1-year post random assignment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2017.
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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.
Robert Wood, p study director
Mathematica Policy Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Steps to Success and Traditional Healthy Families in people with Pregnancy, run by Mathematica Policy Research, Inc. 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 0 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: status not confirmed, as of the sponsor's last update on 17 Apr 2017. 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?
Results are not available in the source record.
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?
Subsequent pregnancy (time frame: 2-years post random assignment). 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 17 Apr 2017; AzTrials last refreshed its copy on 3 Nov 2026.