- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01456091
Evaluation of the Efficacy of the AIM (Adult Identity Mentoring) 4 Teen Moms Program
March 21, 2016 updated by: Mathematica Policy Research, Inc.
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
954
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States, 90027
- Children's Hospital Los Angeles
-
Los Angeles, California, United States, 900047
- El Nido Family Centers-Manchester
-
Mission Hills, California, United States, 91345
- El Nido Family Centers-Mission Hills
-
Pacoima, California, United States, 91331
- El Nido Family Centers-Pacoima
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 19 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
|
|
Experimental: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of repeat pregnancy
Time Frame: 24 months after baseline
|
24 months after baseline
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adherence to contraception
Time Frame: 12 months after baseline
|
12 months after baseline
|
Adherence to contraception
Time Frame: 24 months after baseline
|
24 months after baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (Actual)
January 1, 2016
Study Completion (Actual)
January 1, 2016
Study Registration Dates
First Submitted
October 18, 2011
First Submitted That Met QC Criteria
October 19, 2011
First Posted (Estimate)
October 20, 2011
Study Record Updates
Last Update Posted (Estimate)
March 22, 2016
Last Update Submitted That Met QC Criteria
March 21, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MPR06549-2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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