Evaluating the El Camino Program
NCT Number: NCT06485284
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sexual Behavior|Adolescent Behavior
Interventions: BEHAVIORAL: El Camino|BEHAVIORAL: Life skills program
Sponsor: Child Trends
Collaborators: Identity, Inc.|University of Maryland
Sex: ALL
Age: CHILD, ADULT
Enrollment: 746
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2021-02-17
Completion Date: 2024-01-25
Locations: Identity, Inc., Gaithersburg, Maryland, 20877, United States|Montgomery County Public Schools, Rockville, Maryland, 20850, United States

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

Primary Outcome Measures: Ever had penis-in-vagina sex, Ever had penis-in-vagina sex (yes/no). Dichotomous variable coded 1 if yes, 0 if no and missing otherwise, Immediately following program completion, 12 months after program completion|Had penis-in-vagina sex in the last three months, Had penile-vaginal sex in the past three months, even once (yes/no). Dichotomous variable coded 1 if yes, 0 if no and missing otherwise, Immediately following program completion, 12 months after program completion|Had penis-in-vagina sex in the last three months without any method of contraception, Survey measure: "In the past 3 months, how often have you or your partner used any method of birth control, including condoms, during penis-in-vagina sex?" 5 response categories: 4-point scale from "All of the time" (4) to "None of the time" (1) and I don't know. Coded as 0 if answer is "All of the time". Otherwise coded as 1, Immediately following program completion, 12 months after program completion|Had penis-in-vagina sex in the last three months without use of a condom, Survey measure: "In the past 3 months, how often have you or your partner used condoms during penis-in-vagina sex?" 5 response categories: 4-point scale from "All of the time" (4) to "None of the time" (1) and I don't know. Coded as 0 if answer is "All of the time". Otherwise coded 1, Immediately following program completion, 12 months after program completion
Secondary Outcome Measures: Intend to use condoms, Intend to use condoms if having sex (dichotomous variable coded as 1 if responds yes definitely vs. 0 if probably yes, probably not, or

definitely not), Immediately following program completion, 12 months after program completion|Intend to use contraception, Intend to use contraception if having sex (dichotomous variable coded as 1 if responds yes definitely vs. 0 if any other response), Immediately following program completion, 12 months after program completion|Awareness of birth control methods, Sum the # of methods responding "yes" to "have you heard of any of these methods of birth control" - response options: 0-6, Immediately following program completion, 12 months after program completion|Knowledge about condoms, Sum the # of correct responses to 5 items (sample item: "Condoms have an expiration date"-"don't know" is considered an incorrect response), Immediately following program completion, 12 months after program completion|Knowledge about birth control, Sum the # of correct responses to 4 items (sample item: "The IUD is more effective at preventing pregnancy than the condom"-"don't know" is considered an incorrect response), Immediately following program completion, 12 months after program completion|Knowledge about consent, Sum the # of correct responses to 5 items (sample item: "Is someone consenting to have sex with you if they make out with you clothed"-"don't know" is considered an incorrect response), Immediately following program completion, 12 months after program completion|Attitudes about birth control, Average score of 2 items (birth control pills are effective at preventing pregnancy, birth control has too many side effects). Response options on 4-point scale from Strongly disagree to strongly agree), Immediately following program completion, 12 months after program completion|Attitudes about condoms, Dichotomous variable measuring 1 if answers "strongly agree" to condoms should always be used, and "strongly disagree" to it is ok if you forget to

use condoms sometimes. Response options on 4-point scale from Strongly disagree to strongly agree, Immediately following program completion, 12 months after program completion|Definitely know where to get birth control, Dichotomous variable measured as 1 if respond "definitely" and 0 for all other responses (probably do, probably don't, or definitely don't know where to get birth control methods), Immediately following program completion, 12 months after program completion|Confidence going to a clinic to get contraception, Response options on 4-point scale

from "not at all confident" to

"completely confident", Immediately following program completion, 12 months after program completion|Confidence discussing sex, contraception, Average score of 2 items (how confident you could talk to your partner about whether to have sex, talk to your partner about using condoms. Response options on 4-point scale from "Strongly disagree to strongly agree), Immediately following program completion, 12 months after program completion|Confidence limit setting, Average score of 3 items (sample item: "how confident you could say no to sex if your partner won't use a condom") Response options on 4-point scale from "Strongly disagree to strongly agree), Immediately following program completion, 12 months after program completion|Confidence stating and asking for consent, Dichotomous variable coded as 1 if "completely confident" on 2 items (vs.

all other responses), Immediately following program completion, 12 months after program completion|Decreased psychological distress, Kessler Psychological Distress Scale (K6) - frequency of 6 symptoms over the past 30 days. Response options on 5-point scale from "none of the time" (coded 1) to "all of the time" (coded 5). Scores summed across all 6 symptoms. Used as a continuous score, Immediately following program completion, 12 months after program completion|Increased educational goal setting, How likely is it that you will do each of the

following: (a) graduate from high school; (b) continue education after high school; (c) graduate from college. Response options on a 5-point scale from "not at all likely" (coded 1) to "completely likely" (coded 5). Scores for each item used separately as continuous scores, Immediately following program completion, 12 months after program completion