Clinical trial NCT06485284: Evaluating the El Camino Program
Official title: El Camino: Tier 2 Rigorous Evaluation of Promising Interventions in Promotion of Healthy Adolescence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Behavior
Adolescent Behavior
Lead sponsor: Child Trends
Sponsor class: OTHER
Collaborators: name: Identity, Inc.
name: University of Maryland
First posted: 2024-07-03
Enrollment: 746
Sex: ALL
Minimum age (years): 14
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this randomized controlled trial is to evaluate the impacts of El Camino, a goal-setting sexual health promotion program targeted toward Latino adolescents. The primary research questions are:

* Research Question 1: Is participation in the El Camino goal setting program associated with greater abstinence (measured as never had sex, no recent sexual activity) relative to a comparison group that did not receive El Camino?
* Research Question 2: Is participation in El Camino associated with reduced unprotected sex (measured as sex without any method of contraception, sex without a condom) for the intervention group relative to the comparison group?

Researchers will compare those who received El Camino to a comparison group who received an alternative program that does not include sexual health components.

As part of the study, participants will be asked to:

* Attend approximately 11 hours of programming completed over 11 weeks
* Complete baseline, post-intervention, and 12-month follow-up surveys
* For select participants who received the El Camino program, participate in an optional focus group discussion


Eligibility criteria: Inclusion Criteria:

* High school student in Montgomery County, MD
* Have not previously received El Camino during pilot study
* Have parental consent (if under 18)
* Agree to be in study

Exclusion Criteria:

* Previously participated in pilot study and received El Camino curriculum
* No parental consent (if under 18)
* Do not agree to be in study

Primary outcomes:
measure: Ever had penis-in-vagina sex
timeFrame: Immediately following program completion, 12 months after program completion
measure: Had penis-in-vagina sex in the last three months
timeFrame: Immediately following program completion, 12 months after program completion
measure: Had penis-in-vagina sex in the last three months without any method of contraception
timeFrame: Immediately following program completion, 12 months after program completion
measure: Had penis-in-vagina sex in the last three months without use of a condom
timeFrame: Immediately following program completion, 12 months after program completion
Secondary outcomes:
measure: Intend to use condoms
timeFrame: Immediately following program completion, 12 months after program completion
measure: Intend to use contraception
timeFrame: Immediately following program completion, 12 months after program completion
measure: Awareness of birth control methods
timeFrame: Immediately following program completion, 12 months after program completion
measure: Knowledge about condoms
timeFrame: Immediately following program completion, 12 months after program completion
measure: Knowledge about birth control
timeFrame: Immediately following program completion, 12 months after program completion
measure: Knowledge about consent
timeFrame: Immediately following program completion, 12 months after program completion
measure: Attitudes about birth control
timeFrame: Immediately following program completion, 12 months after program completion
measure: Attitudes about condoms
timeFrame: Immediately following program completion, 12 months after program completion
measure: Definitely know where to get birth control
timeFrame: Immediately following program completion, 12 months after program completion
measure: Confidence going to a clinic to get contraception
timeFrame: Immediately following program completion, 12 months after program completion
measure: Confidence discussing sex, contraception
timeFrame: Immediately following program completion, 12 months after program completion
measure: Confidence limit setting
timeFrame: Immediately following program completion, 12 months after program completion
measure: Confidence stating and asking for consent
timeFrame: Immediately following program completion, 12 months after program completion
measure: Decreased psychological distress
timeFrame: Immediately following program completion, 12 months after program completion
measure: Increased educational goal setting
timeFrame: Immediately following program completion, 12 months after program completion
Other outcomes:
Locations:
city: Gaithersburg
country: United States
facility: Identity, Inc.
state: Maryland
city: Rockville
country: United States
facility: Montgomery County Public Schools
state: Maryland
Study officials:
References:
citation: Faccio B, McClay A, McConnell K, Gates C, Finocharo J, Tallant J, Martinez V, Manlove J. Comparing Virtual and In-Person Implementation of a School-Based Sexual Health Promotion Program in High Schools with Large Latino Populations. Prev Sci. 2023 Dec;24(Suppl 2):251-261. doi: 10.1007/s11121-023-01526-0. Epub 2023 Jun 23.