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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00342706
Recruitment Status : Completed
First Posted : June 21, 2006
Last Update Posted : July 2, 2017
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Tracking Information
First Submitted Date  ICMJE June 19, 2006
First Posted Date  ICMJE June 21, 2006
Last Update Posted Date July 2, 2017
Study Start Date  ICMJE January 10, 2005
Actual Primary Completion Date April 29, 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2006)
Delay of a subsequent pregnancy.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00342706 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Building Healthy Teen Relationships and Reproductive Practices to Increase Intervals Between Pregnancies
Official Title  ICMJE Building Healthy Teen Relationships and Reproductive Practices to Increase Interpregnancy Intervals
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...

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE Teen Pregnancy
Intervention  ICMJE Procedure: Community based intervention
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June 19, 2006)
750
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 29, 2011
Actual Primary Completion Date April 29, 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • INCLUSION CRITERIA:

The following criteria will determine eligibility for the study:

  1. African American and Latino primiparous pregnant or newly parenting (0-6 weeks);
  2. Age 15-18 years inclusive; and
  3. Teens who are 19 years old if they have not graduated from high school.

EXCLUSION CRITERIA:

  1. Non-English speaking;
  2. Any serious medical condition or disability that would interfere with the participant responding adequately to evaluation measures;
  3. Obvious cognitive impairment that interferes in participating in informed consent;
  4. Incarceration at enrollment or during the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 15 Years to 19 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00342706
Other Study ID Numbers  ICMJE 999905083
05-CH-N083
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date April 29, 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP