NCT00342706

Brief 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. 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...

Trial Health

87
On Track

Trial Health Score

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

Enrollment
750

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2005

Longer than P75 for phase_2

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2005

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2006

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2011

Completed
Last Updated

July 2, 2017

Status Verified

April 29, 2011

Enrollment Period

6.3 years

First QC Date

June 19, 2006

Last Update Submit

June 30, 2017

Conditions

Keywords

Teen PregnancyShort Inter-Pregnancy Intervals

Outcome Measures

Primary Outcomes (1)

  • Delay of a subsequent pregnancy.

Interventions

Eligibility Criteria

Age15 Years - 19 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Child Health and Human Development (NICHD), 9000 Rockville

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • 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.

    PMID: 11008086BACKGROUND
  • Akinbami 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.

    PMID: 11572313BACKGROUND
  • Blake 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.

    PMID: 12773362BACKGROUND

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

June 19, 2006

First Posted

June 21, 2006

Study Start

January 10, 2005

Primary Completion

April 29, 2011

Study Completion

April 29, 2011

Last Updated

July 2, 2017

Record last verified: 2011-04-29

Locations