PregnancyBRIDGESNCT00537108
Community-Based Care Management For Teen/Young Adult Mothers and Fathers
A study testing Home visiting and care management in people with Pregnancy, run by University of Maryland, Baltimore at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Pregnancy
- What is being tested?
- Home visiting and care management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Sep 2011
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UMB School of Medicine Department of Family and Community Medicine
Baltimore, Maryland, 21201
About this study
Official title: BRIDGES: A Randomized Trial of Community-Based Care Management For Teen/Young Adult Mothers and Fathers
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.
Read the 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.
- Conditions
- Pregnancy
- Being tested
- Home visiting and care management
- Keywords
- Pregnancy in adolescence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home visiting and care managementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| HV | Experimental | Intervention arm. Receives: Behavioral: Home visiting and care management |
| Cntr | No intervention | Usual care control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repeat pregnancy
Measured: Within 2 years of the index birth
Parenting attitudes and behaviors
Measured: at 1 year and 2 years postpartum
School continuation or graduation
Measured: at 2 years postpartum
Secondary outcomes (1)
Remission of depression
Measured: at 1 year and 2 years postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2007 (estimated)
- Study startAug 2007
- Primary completionSep 2011
- Study completionSep 2011
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.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- 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
- Single group
- Model description
- Motivational intervention and support
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- UMB School of Medicine Department of Family and Community Medicine, Department of Health and Human Services
- Responsible party
- Principal investigator, Beth Barnet, University of Maryland, Baltimore
- Investigators
- Beth Barnet, M.D., Principal investigator, University of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00537108
- Sponsor's protocol ID
- H-29138
- Acronym
- BRIDGES
- Status last verified
- Oct 2022
- First submitted
- 27 Sep 2007
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BRIDGES: A Randomized Trial of Community-Based Care Management For Teen/Young Adult Mothers and Fathers
- ClinicalTrials.gov ID
- NCT00537108
- Acronym / sponsor ID
- BRIDGES / H-29138
- Conditions
- Pregnancy
- Keywords
- Pregnancy in adolescence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- UMB School of Medicine Department of Family and Community Medicine, Department of Health and Human Services
- Study start
- Aug 2007
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 28 Sep 2007 (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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Motivational intervention and support
| Arm | Type | Receives |
|---|---|---|
| HV | Experimental | Behavioral: Home visiting and care managementIntervention arm. |
| Cntr | No intervention | –Usual care control |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Home visiting and care managementThird 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. | Behavioural | HV |
Primary outcome
Repeat pregnancy
Time frame: Within 2 years of the index birth
Parenting attitudes and behaviors
Time frame: at 1 year and 2 years postpartum
School continuation or graduation
Time frame: at 2 years postpartum
1 secondary outcome
Remission of depression
Time frame: at 1 year and 2 years postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Individual participant dataSharing planned: No
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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.
Beth Barnet, M.D. principal investigator
University of Maryland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home visiting and care management in people with Pregnancy, run by University of Maryland, Baltimore 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 2 Nov 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Repeat pregnancy (time frame: Within 2 years of the index birth). The study lists 3 primary outcomes in all. 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 2 Nov 2022.