Teen PregnancyPhase 2NCT00342706
Building Healthy Teen Relationships and Reproductive Practices to Increase Intervals Between Pregnancies
A Phase 2 study testing Community based intervention in people with Teen Pregnancy, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial summary
This study will determine the best ways to help teen mothers stay healthy and to increase the time between their pregnancies to at least 2 years. It is designed to encourage attitudes and behaviors that are generally thought to be related to longer intervals between pregnancies. Read more about this study
- Who is it for?
- Ages 15 to 19 years, women only
- Conditions the study is for
- Teen Pregnancy
- What is being tested?
- Community based intervention
- Type of treatment
- Surgery or procedure
- How many people
- 750 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2005to 29 Apr 2011
- Phase
- Phase 2
- 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 15 to 19 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- The following criteria will determine eligibility for the study:
- African American and Latino primiparous pregnant or newly parenting (0-6 weeks);
- Age 15-18 years inclusive; and
- Teens who are 19 years old if they have not graduated from high school.
Who cannot join
- Non-English speaking;
- Any serious medical condition or disability that would interfere with the participant responding adequately to evaluation measures;
- Obvious cognitive impairment that interferes in participating in informed consent;
- Incarceration at enrollment or during the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Child Health and Human Development (NICHD), 9000 Rockville
Bethesda, Maryland, 20892
About this study
Official title: Building Healthy Teen Relationships and Reproductive Practices to Increase Interpregnancy Intervals
This study will determine the best ways to help teen mothers stay healthy and to increase the time between their pregnancies to at least 2 years. It is designed to encourage attitudes and behaviors that are generally thought to be related to longer intervals between pregnancies. Children of teen mothers generally receive less health care, have lower IQ scores and are more likely to enter foster care. They have less supportive home environments and higher rates of incarceration and teen childbearing.
African-American and Latino teenagers living in the Washington, D.C., metropolitan area who are pregnant with their first baby may be eligible for this study. Mothers or mother figures of the teens also are encouraged to participate. Candidates must be between 15 and 18 year of age and speak English.
Read more
Teen mothers enrolled in the study take a urine pregnancy test every 6 months during this 2-year study. They are randomly assigned to one of the following two groups:
Usual Care Group: Teens in this group are interviewed by telephone for about 1 hour every 6 months and for about 15 minutes at 3, 9, 15 and 21 months. The hour-long interview includes questions about the teen's feelings and behaviors, risks to her health and well being, and how she communicates with her boyfriend and family members. She is also asked about what she does to reach personal goals, what she thinks about sexual health, and what support she gets from her family, boyfriend, or others. The 15-minute interview is an update to check on the teen's health and pregnancy status and to verify contact information.
Intervention Group: Teens in this group are asked the same questions as those in the usual care group; however, they are involved in a project designed to encourage them to set goals of furthering their education and training and wait at least 2 years before becoming pregnant again. Teens in this group are counseled on learning to communicate and work out problems with their family and boyfriend and on how to keep from getting pregnant again soon. The participants meet for a 2-hour group session every 3 months at a local health center and are contacted frequently by a cell phone, which is provided to them at no cost. The phone sessions are about things that are important to the teens, such as problems in their relationships, health, sexually transmitted diseases, and preventing another pregnancy too soon. The conversations are private and take about 45 minutes.
Mothers (or...
Read the detailed description
The major objective of this program is to test the effectiveness of a community based intervention for minority teen mothers. The primary aim of the project is to: Evaluate the effectiveness of a community based intervention for minority teen mothers, with the primary purpose of increasing the inter-pregnancy interval to greater than 24 months. The secondary aim is to evaluate the effectiveness of a community based intervention for minority teen mothers, with a secondary purpose of improving knowledge, attitudes, behaviors, relationships and connectedness generally understood to be related to length of inter-pregnancy intervals.
- Conditions
- Teen Pregnancy
- Being tested
- Community based intervention
- Keywords
- Teen Pregnancy, Short Inter-Pregnancy Intervals
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community based interventionProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Delay of a subsequent pregnancy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start10 Jan 2005
- Primary completion29 Apr 2011
- Study completion29 Apr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Teen PregnancyStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00342706
- Sponsor's protocol ID
- 999905083
- Other IDs
- 05-CH-N083
- Status last verified
- 29 Apr 2011
- First submitted
- 19 Jun 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Aarons SJ, Jenkins RR, Raine TR, El-Khorazaty MN, Woodward KM, Williams RL, Clark MC, Wingrove BK. Postponing sexual intercourse among urban junior high school students-a randomized controlled evaluation. J Adolesc Health. 2000 Oct;27(4):236-47. doi: 10.1016/s1054-139x(00)00102-6.
PubMed 11008086Akinbami LJ, Cheng TL, Kornfeld D. A review of teen-tot programs: comprehensive clinical care for young parents and their children. Adolescence. 2001 Summer;36(142):381-93.
PubMed 11572313Blake SM, Ledsky R, Goodenow C, Sawyer R, Lohrmann D, Windsor R. Condom availability programs in Massachusetts high schools: relationships with condom use and sexual behavior. Am J Public Health. 2003 Jun;93(6):955-62. doi: 10.2105/ajph.93.6.955.
PubMed 12773362
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Healthy Teen Relationships and Reproductive Practices to Increase Interpregnancy Intervals
- ClinicalTrials.gov ID
- NCT00342706
- Acronym / sponsor ID
- 999905083
- Conditions
- Teen Pregnancy
- Keywords
- Teen Pregnancy, Short Inter-Pregnancy Intervals
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 10 Jan 2005
- Primary completion
- 29 Apr 2011 (actual)
- Study completion
- 29 Apr 2011 (actual)
- First posted
- 21 Jun 2006 (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.
This study will determine the best ways to help teen mothers stay healthy and to increase the time between their pregnancies to at least 2 years. It is designed to encourage attitudes and behaviors that are generally thought to be related to longer intervals between pregnancies. Children of teen mothers generally receive less health care, have lower IQ scores and are more likely to enter foster care. They have less supportive home environments and higher rates of incarceration and teen childbearing.
African-American and Latino teenagers living in the Washington, D.C., metropolitan area who are pregnant with their first baby may be eligible for this study. Mothers or mother figures of the teens also are encouraged to participate. Candidates must be between 15 and 18 year of age and speak English.
Teen mothers enrolled in the study take a urine pregnancy test every 6 months during this 2-year study. They are randomly assigned to one of the following two groups:
Usual Care Group: Teens in this group are interviewed by telephone for about 1 hour every 6 months and for about 15 minutes at 3, 9, 15 and 21 months. The hour-long interview includes questions about the teen's feelings and behaviors, risks to her health and well being, and how she communicates with her boyfriend and family members. She is also asked about what she does to reach personal goals, what she thinks about sexual health, and what support she gets from her family, boyfriend, or others. The 15-minute interview is an update to check on the teen's health and pregnancy status and to verify contact information.
Intervention Group: Teens in this group are asked the same questions as those in the usual care group; however, they are involved in a project designed to encourage them to set goals of furthering their education and training and wait at least 2 years before becoming pregnant again. Teens in this group are counseled on learning to communicate and work out problems with their family and boyfriend and on how to keep from getting pregnant again soon. The participants meet for a 2-hour group session every 3 months at a local health center and are contacted frequently by a cell phone, which is provided to them at no cost. The phone sessions are about things that are important to the teens, such as problems in their relationships, health, sexually transmitted diseases, and preventing another pregnancy too soon. The conversations are private and take about 45 minutes.
Mothers (or...
Detailed description
The major objective of this program is to test the effectiveness of a community based intervention for minority teen mothers. The primary aim of the project is to: Evaluate the effectiveness of a community based intervention for minority teen mothers, with the primary purpose of increasing the inter-pregnancy interval to greater than 24 months. The secondary aim is to evaluate the effectiveness of a community based intervention for minority teen mothers, with a secondary purpose of improving knowledge, attitudes, behaviors, relationships and connectedness generally understood to be related to length of inter-pregnancy intervals.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 15 to 19 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- African American and Latino primiparous pregnant or newly parenting (0-6 weeks);
- Age 15-18 years inclusive; and
- Teens who are 19 years old if they have not graduated from high school.
Key exclusion criteria (4 listed)
- Non-English speaking;
- Any serious medical condition or disability that would interfere with the participant responding adequately to evaluation measures;
- Obvious cognitive impairment that interferes in participating in informed consent;
- Incarceration at enrollment or during the study.
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 |
|---|---|---|
| Community based intervention | Procedure or surgery | – |
Primary outcome
Delay of a subsequent pregnancy.
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 Jul 2017.
- Background: PubMed 11008086Aarons SJ, Jenkins RR, Raine TR, El-Khorazaty MN, Woodward KM, Williams RL, Clark MC, Wingrove BK. Postponing sexual intercourse among urban junior high school students-a randomized controlled evaluation. J Adolesc Health. 2000 Oct;27(4):236-47. doi: 10.1016/s1054-139x(00)00102-6.
- Background: PubMed 11572313Akinbami LJ, Cheng TL, Kornfeld D. A review of teen-tot programs: comprehensive clinical care for young parents and their children. Adolescence. 2001 Summer;36(142):381-93.
- Background: PubMed 12773362Blake SM, Ledsky R, Goodenow C, Sawyer R, Lohrmann D, Windsor R. Condom availability programs in Massachusetts high schools: relationships with condom use and sexual behavior. Am J Public Health. 2003 Jun;93(6):955-62. doi: 10.2105/ajph.93.6.955.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Community based intervention in people with Teen Pregnancy, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 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 4 inclusion and 4 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 Jul 2017. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Delay of a subsequent pregnancy.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00342706, which also lists 3 linked publications.
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 Jul 2017.