- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05796687
Evaluation of My Future Self, an New Teen Pregnancy Prevention Group Intervention for Youth in Non-traditional Settings
Evaluation of My Future Self, an Innovative Teen Pregnancy Prevention Intervention
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Children's Hospital Los Angeles and ETR will implement and test the effectiveness of a pregnancy prevention intervention, My Future Self, targeting youth ages 16-19 in Los Angeles and San Diego Counties who, for a variety of reasons, are receiving education or training in non-traditional settings. These youth typically experience a combination of needs related to unstable or no housing, extreme poverty, involvement with child welfare or juvenile justice, historical trauma, and/or learning differences.
Currently, there are a few evidence-based interventions that focus on sub populations of these youth in alternative schools (All4You!, All4You2!), those at risk for dropping out of school (Crossroads/TCAP), and those coming from out of home care settings (Power Through Choices). However additional interventions are needed as these youth represent a vulnerable population with unique needs and barriers to pregnancy prevention requiring approaches that are tailored to nontraditional educational settings, familial circumstances, developmental trajectory, and that are synergistic with the generational reliance on technology.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90027
- Children's Hospital Los Angeles
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Youth will be eligible for enrollment in the evaluation if they:
- Are served, or identified on outreach, by one of our partner youth-serving agencies or schools
- Are ages 16-19 years
- Are English-language speakers
- Are not currently pregnant
- Have no immediate travel plans (i.e., are planning on being in the area for the length of the intervention)
- Have not previously enrolled in the study, and
- Answer the baseline survey items related to our primary outcome (which will be assessed after completion of the baseline survey).
Exclusion Criteria:
- Outside of age range
- Currently pregnant
- Not planning to be in the area for the length of the intervention)
- Previously enrolled in the study
Study Plan
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 |
|---|---|
|
Experimental: My Future Self Intervention
My Future Self - 5 group sessions; 1 hour each over 5 weeks; content includes: health education around abstinence and contraception methods, and consideration of goals of parenthood and family planning in their adult future; future plans, discussion of healthy intimate partner relationships/
|
My Future Self is based upon the Theory of Possible Selves, which promotes the capacity of young people to construct goals for a successful adulthood.
Youth who hold a balanced set of negative and positive images of their future have both a) a positive goal to strive for and b) awareness of the personally relevant consequences of not meeting that goal.
My Future Self also includes two new supportive gaming elements that reinforce learning of relevant knowledge and skills as well as provide opportunities for youth to individually practice these skills in a personalized virtual environment.
Gaming interventions using interactive technology can significantly increase self-reported abstinence and lower reports of diagnosed STD in young women, as well as reduce risky sex for men and women.
Youth will participate in these gaming elements on tablets provided by CHLA.
My Future Self will be implemented as a ninety-minute small group 5-week program.
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No Intervention: Control
Youth will continue to receive any services that they would normally receive around health education.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Protection from pregnancy in the past 90 days
Time Frame: Past 90 days
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Had vaginal sex in the past 90 days (% No) OR Used contraception, at least 80% of the time when having vaginal sex (% Yes)
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Past 90 days
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mona Desai, Children's Hospital Los Angeles
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CHLA-23-00049
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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