Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

Evaluation of the Efficacy of the AIM (Adult Identity Mentoring) 4 Teen Moms Program

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Children's Hospital Los Angeles
ETR Associates
Information provided by (Responsible Party):
Mathematica Policy Research, Inc.
ClinicalTrials.gov Identifier:
NCT01456091
First received: October 18, 2011
Last updated: April 28, 2014
Last verified: April 2014
History of Changes
  Purpose

The purpose of this study is to evaluate the efficacy of the AIM 4 Teen Moms program in increasing the use of long-term contraceptives, in improving adherence to contraceptives and in preventing rapid repeat pregnancies among parenting adolescents.


Condition Intervention
Pregnancy
 Behavioral: AIM 4 Teen Moms

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of the Efficacy of the AIM (Adult Identity Mentoring) 4 Teen Moms Program

Further study details as provided by Mathematica Policy Research, Inc.:

Primary Outcome Measures:
  • Incidence of repeat pregnancy [ Time Frame: 24 months after baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adherence to contraception [ Time Frame: 12 months after baseline ] [ Designated as safety issue: No ]
  • Adherence to contraception [ Time Frame: 24 months after baseline ] [ Designated as safety issue: No ]
Estimated Enrollment: 1400
Study Start Date: October 2011
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AIM 4 Teen Moms Behavioral: AIM 4 Teen Moms
The AIM (Adult Identity Mentoring) 4 Teen Moms program is a combination of individual and small group sessions intervention that encourages parenting young women ages 15-19 years old to delay rapid repeat pregnancies for 24 months or later.
No Intervention: Control

Detailed Description:

This study uses a randomized controlled design to evaluate the efficacy of AIM (Adult Identity Mentoring) 4 Teen Moms in reducing the incidence of rapid repeat pregnancies and associated sexual risk behavior. The AIM 4 Teen Moms program is a combination of individual and small group sessions intervention that encourages parenting young women ages 15-19 years old to delay rapid repeat pregnancies for 24 months or later. It consists of seven individual 1-hour long sessions (generally conducted in the participant's home) and two 90-minute group sessions delivered over a 12 week period. Study participants will be adolescent mothers receiving services from California's Adolescent Family Life or Cal-Learn programs in the Los Angeles County area. There will be no intervention delivered to members of the control group. This study is being conducted as part of the national Evaluation of Adolescent Pregnancy Prevention Approaches funded by the U.S. Department of Health and Human Services' Office of Adolescent Health.

  Eligibility
Ages Eligible for Study:   15 Years to 19 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Beneficiaries of California's Adolescent Family Life or Cal-Learn programs in the Los Angeles County area
  • Female
  • 15 - 19 years old
  • Has a child between the ages 1 and 6 months at program start
  • English or Spanish speaker
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01456091

Locations
United States, California
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
El Nido Family Centers-Manchester
Los Angeles, California, United States, 900047
El Nido Family Centers-Mission Hills
Mission Hills, California, United States, 91345
El Nido Family Centers-Pacoima
Pacoima, California, United States, 91331
Sponsors and Collaborators
Mathematica Policy Research, Inc.
Children's Hospital Los Angeles
ETR Associates
Investigators
Principal Investigator: Christopher Trenholm, Ph.D. Mathematica Policy Research
Principal Investigator: Reginald Covington, Ph.D. Mathematica Policy Research
Principal Investigator: Pamela Drake, Ph.D. ETR Associates
  More Information

No publications provided

Responsible Party: Mathematica Policy Research, Inc.
ClinicalTrials.gov Identifier: NCT01456091     History of Changes
Other Study ID Numbers: MPR06549-2
Study First Received: October 18, 2011
Last Updated: April 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mathematica Policy Research, Inc.:
adolescent pregnancy
adolescent birth
rapid repeat pregnancy
 rapid repeat birth
youth development
Pregnancy in Adolescence

ClinicalTrials.gov processed this record on February 27, 2015