NCT00537108

Brief Summary

Teenagers who become parents often struggle with new challenges as they try to take care of their children and themselves. Programs that provide teens with support, education, and counseling may help teens to become the best parents they can be and reach their own goals. Health care providers who take care of pregnant and parenting teenagers are trying to find out what types of programs are most helpful for the physical, emotional, and social health of pregnant and parenting teenagers. The purpose of this study is to find out what kinds of activities help teens be successful as parents and achieve success in their lives.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P50-P75 for not_applicable pregnancy

Timeline
Completed

Started Aug 2007

Longer than P75 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 28, 2007

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

November 2, 2022

Status Verified

October 1, 2022

Enrollment Period

4.1 years

First QC Date

September 27, 2007

Last Update Submit

October 30, 2022

Conditions

Keywords

Pregnancy in adolescence

Outcome Measures

Primary Outcomes (3)

  • Repeat pregnancy

    Within 2 years of the index birth

  • Parenting attitudes and behaviors

    at 1 year and 2 years postpartum

  • School continuation or graduation

    at 2 years postpartum

Secondary Outcomes (1)

  • Remission of depression

    at 1 year and 2 years postpartum

Study Arms (2)

HV

EXPERIMENTAL

Intervention arm.

Behavioral: Home visiting and care management

Cntr

NO INTERVENTION

Usual care control

Interventions

Third trimester teens are assigned a Care Manager (CM) who establishes a continuity relationship and provides monthly visits until the index child is 2 years old. Core services for intervention group include: 1)Baseline and ongoing assessment of health, mental health, housing, daycare, and school needs; 2)Administration of a culturally sensitive, developmentally relevant parenting curriculum; 3)Computer Assisted Motivational Interviewing to promote healthy relationships, improve contraceptive practices, focus on goals, and promote school continuation; 4)Efforts to engage the young father; 5)Linkage and coordination with primary care for teen, child, young father; 6)Support \& skills-building for school continuation, higher education, and job readiness.

HV

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Pregnant teenagers
  • Ages 12-18 years old
  • \>= 24 weeks gestation
  • Attending any of 5 West Baltimore prenatal care sites.
  • Male partner (baby's father) if the pregnant teenager agrees to let the program contact him to invite participation.

You may not qualify if:

  • Age \< 18 years and no parent/guardian able to grant consent.
  • Male partner of a pregnant teen/teen mother if she does not grant consent to let us contact him and invite participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMB School of Medicine Department of Family and Community Medicine

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Interventions

House Calls

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services Administration

Study Officials

  • Beth Barnet, M.D.

    University of Maryland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Motivational intervention and support
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Family and Community Medicine

Study Record Dates

First Submitted

September 27, 2007

First Posted

September 28, 2007

Study Start

August 1, 2007

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

November 2, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations