NCT02052843

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
595

participants targeted

Target at P75+ for not_applicable pregnancy

Timeline
Completed

Started May 2013

Longer than P75 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
unknown

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

May 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 3, 2014

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

April 17, 2017

Status Verified

April 1, 2017

Enrollment Period

5.1 years

First QC Date

January 30, 2014

Last Update Submit

April 13, 2017

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

  • Subsequent pregnancy

    2-years post random assignment

Secondary Outcomes (1)

  • Subsequent pregnancy

    1-year post random assignment

Study Arms (2)

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.

Behavioral: Steps to Success

Traditional Healthy Families

ACTIVE COMPARATOR

Traditional Healthy Families home visits which cover topics of parenting and child development

Behavioral: Traditional Healthy Families

Interventions

Steps to SuccessBEHAVIORAL
Steps to Success
Traditional Healthy FamiliesBEHAVIORAL
Traditional Healthy Families

Eligibility Criteria

Age14 Years - 21 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Female
  • Age 14 to 21
  • Pregnant, or have delivered a child in the last three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Healthy Families San Angelo

San Angelo, Texas, 76903, United States

Location

Study Officials

  • Robert Wood, p

    Mathematica Policy Research

    STUDY DIRECTOR

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

January 30, 2014

First Posted

February 3, 2014

Study Start

May 1, 2013

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

April 17, 2017

Record last verified: 2017-04

Locations

US(1)