NCT00342706

Building Healthy Teen Relationships and Reproductive Practices to Increase Intervals Between Pregnancies

Completed Phase 2 Last updated 2 July 2017

What this trial tests

Phase 2 trial testing Community based intervention in Teen Pregnancy in 750 participants. Completed in 29 April 2011.

Timeline

10 January 2005

Primary endpoint
29 April 2011

29 April 2011

Quick facts

Lead sponsor	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Primary purpose	treatment
Enrollment	750
Start date	10 January 2005
Primary completion	29 April 2011
Estimated completion	29 April 2011
Sites	1 location across United States

Drugs / interventions tested

• Community based intervention

Conditions studied

• Teen Pregnancy — all drugs for Teen Pregnancy →

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Who can join

Adults 15 to 19, female only, with Teen Pregnancy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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...

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.