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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05796687
Other study ID # CHLA-23-00049
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 13, 2023
Est. completion date January 31, 2027

Study information

Verified date December 2023
Source Children's Hospital Los Angeles
Contact Mona Desai
Phone 3233613107
Email mdesai@chla.usc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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. My Future Self is a 5 week program consisting of 5 group sessions. Our study will enroll up to 704 highly mobile youth from various sites in Los Angeles and San Diego. Youth will be randomized to receive the My Future Self intervention in conjunction with their regular services or just their regular services. All youth enrolled will complete baseline, 6 month and 12 month surveys.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 704
Est. completion date January 31, 2027
Est. primary completion date January 31, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years to 19 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
My Future Self
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 in high-risk young men who have sex with men. 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.

Locations

Country Name City State
United States Children's Hospital Los Angeles Los Angeles California

Sponsors (2)

Lead Sponsor Collaborator
Children's Hospital Los Angeles ETR Associates

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Protection from pregnancy in the past 90 days Had vaginal sex in the past 90 days (% No) OR Used contraception, at least 80% of the time when having vaginal sex (% Yes) Past 90 days
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