Evaluating the El Camino Program

El Camino: Tier 2 Rigorous Evaluation of Promising Interventions in Promotion of Healthy Adolescence

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

Study Overview

• Status: Completed
• Conditions: Sexual Behavior; Adolescent Behavior
• Intervention / Treatment: Behavioral: El Camino; Behavioral: Life skills program

• Study Type: Interventional
• Enrollment (Actual): 746
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Gaithersburg, Maryland, United States, 20877
      • Identity, Inc.
    • Rockville, Maryland, United States, 20850
      • Montgomery County Public Schools

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: El Camino; Adolescents receiving the intervention/treatment - El Camino.	Behavioral: El Camino; El Camino is a goal-setting sexual health promotion program. El Camino's lessons and activities: Are anchored in sexual health promotion and goal-setting; Incorporate a goal achievement model throughout the curriculum; Are designed with a focus on the needs of Latino youth; Focus on the most effective forms of contraception, including long-acting reversible contraceptives The El Camino curriculum contains eleven 45-minute lessons and is divided into three sections, or arcs. The three arcs focus on goal setting, sexual and reproductive health, and healthy relationships.
Other: Control; Adolescents receiving the control - alternative life skills program.	Behavioral: Life skills program; Youth enrolled in the control condition will receive one of several curricula focused on life skills or leadership, depending on the site and implementation period. These curricula include PODER, an 11-session curriculum that focuses on youth leadership development; Youth Encuentros, a psychoeducational curriculum focused on mental health; El Joven Noble, a youth leadership curriculum; and Courageous Queens, a socio-emotional and character strengthening curriculum.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Child Trends
• Collaborators: University of Maryland; Identity, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2021
• Primary Completion (Actual): January 25, 2024
• Study Completion (Actual): January 25, 2024

Study Registration Dates

• First Submitted: June 26, 2024
• First Submitted That Met QC Criteria: June 26, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: June 26, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: TP2AH000077

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No