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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00537108
Other study ID # H-29138
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2007
Est. completion date September 2011

Study information

Verified date October 2022
Source University of Maryland, Baltimore
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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: 1. Baseline and ongoing monthly needs assessment for healthcare, mental health, school/job attainment, daycare, housing stability; 2. 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; 3. Parenting instruction with a culturally sensitive, developmentally relevant parenting curriculum; and 4. 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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date September 2011
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender All
Age group 12 Years to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Home visiting and care management
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.

Locations

Country Name City State
United States UMB School of Medicine Department of Family and Community Medicine Baltimore Maryland

Sponsors (3)

Lead Sponsor Collaborator
University of Maryland, Baltimore Department of Health and Human Services, UMB School of Medicine Department of Family and Community Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Repeat pregnancy Within 2 years of the index birth
Primary Parenting attitudes and behaviors at 1 year and 2 years postpartum
Primary School continuation or graduation at 2 years postpartum
Secondary Remission of depression at 1 year and 2 years postpartum
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