- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00537108
Community-Based Care Management For Teen/Young Adult Mothers and Fathers (BRIDGES)
BRIDGES: A Randomized Trial of Community-Based Care Management For Teen/Young Adult Mothers and Fathers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Pregnant teenagers and teenagers who have children less than 2 weeks old and who attend either University Family Medicine, the Maryland Women's Center, Teen Tot Clinic, University Care at Edmonson Village, Weinberg Community Health Center, or Maryland General Outpatient clinics will be asked to participate in a home visiting and care management program and study. Those agreeing to participate are placed into one of two groups. One group receives a Home Visiting and Care Management Program along with their usual medical care. The other group receives only their usual medical care.
If placed into the home visiting group, the teen is given a home visitor (also called a Care Manager). The Care Manager arranges to meet with the teen every month until the teen's baby is 2 years old. The meetings last about 1 hour and usually take place in the teen's home.
The Care Manager provides 4 Core Services to the teen:
- Baseline and ongoing monthly needs assessment for healthcare, mental health, school/job attainment, daycare, housing stability;
- Computer Assisted Motivational Interviewing (CAMI) sessions with teen mother. In CAMI sessions, the teen answers questions on a laptop computer that assess partner relationships, sexual behaviors, & risk for repeat pregnancy. Following the assessment, the trained Care Manager conducts motivational interviewing, a counseling technique aimed at assisting the teen to improve contraceptive and condom use, focus on goals, and promote school continuation;
- Parenting instruction with a culturally sensitive, developmentally relevant parenting curriculum; and
- Coordination and linkage with primary care and community partners (e.g. UMB Division of Community Psychiatry) with respect to health care, mental health care, and other services.
If the teen grants permission, we will try to contact her baby's father and invite him to participate in similar activities.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- UMB School of Medicine Department of Family and Community Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HV
Intervention arm.
|
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.
|
No Intervention: Cntr
Usual care control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Repeat pregnancy
Time Frame: Within 2 years of the index birth
|
Within 2 years of the index birth
|
Parenting attitudes and behaviors
Time Frame: at 1 year and 2 years postpartum
|
at 1 year and 2 years postpartum
|
School continuation or graduation
Time Frame: at 2 years postpartum
|
at 2 years postpartum
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Remission of depression
Time Frame: at 1 year and 2 years postpartum
|
at 1 year and 2 years postpartum
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Beth Barnet, M.D., University of Maryland
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- H-29138
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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