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Completed

NCT Number: NCT06485284

Evaluating the El Camino Program

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

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Key information

Age range

14 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Identity, Inc., Gaithersburg, Maryland, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

El Camino

Behavioral

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.

Life skills program

Behavioral

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.

Primary outcomes

  1. Ever had penis-in-vagina sex

    Time frame: Immediately following program completion, 12 months after program completion

    Ever had penis-in-vagina sex (yes/no). Dichotomous variable coded 1 if yes, 0 if no and missing otherwise

  2. Had penis-in-vagina sex in the last three months

    Time frame: Immediately following program completion, 12 months after program completion

    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

  3. Had penis-in-vagina sex in the last three months without any method of contraception

    Time frame: Immediately following program completion, 12 months after program completion

    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

  4. Had penis-in-vagina sex in the last three months without use of a condom

    Time frame: Immediately following program completion, 12 months after program completion

    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

Secondary outcomes

  1. Intend to use condoms

    Time frame: Immediately following program completion, 12 months after program completion

    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)

  2. Intend to use contraception

    Time frame: Immediately following program completion, 12 months after program completion

    Intend to use contraception if having sex (dichotomous variable coded as 1 if responds yes definitely vs. 0 if any other response)

  3. Awareness of birth control methods

    Time frame: Immediately following program completion, 12 months after program completion

    Sum the # of methods responding "yes" to "have you heard of any of these methods of birth control" - response options: 0-6

  4. Knowledge about condoms

    Time frame: Immediately following program completion, 12 months after program completion

    Sum the # of correct responses to 5 items (sample item: "Condoms have an expiration date"-"don't know" is considered an incorrect response)

  5. Knowledge about birth control

    Time frame: Immediately following program completion, 12 months after program completion

    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)

  6. Knowledge about consent

    Time frame: Immediately following program completion, 12 months after program completion

    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)

  7. Attitudes about birth control

    Time frame: Immediately following program completion, 12 months after program completion

    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)

  8. Attitudes about condoms

    Time frame: Immediately following program completion, 12 months after program completion

    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

  9. Definitely know where to get birth control

    Time frame: Immediately following program completion, 12 months after program completion

    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)

  10. Confidence going to a clinic to get contraception

    Time frame: Immediately following program completion, 12 months after program completion

    Response options on 4-point scale

    from "not at all confident" to

    "completely confident"

  11. Confidence discussing sex, contraception

    Time frame: Immediately following program completion, 12 months after program completion

    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)

  12. Confidence limit setting

    Time frame: Immediately following program completion, 12 months after program completion

    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)

  13. Confidence stating and asking for consent

    Time frame: Immediately following program completion, 12 months after program completion

    Dichotomous variable coded as 1 if "completely confident" on 2 items (vs.

    all other responses)

  14. Decreased psychological distress

    Time frame: Immediately following program completion, 12 months after program completion

    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

  15. Increased educational goal setting

    Time frame: Immediately following program completion, 12 months after program completion

    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

Sponsors and collaborators

Lead sponsor

Child Trends

Other

Collaborators

  • Identity, Inc.
  • University of Maryland

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 3, 2024
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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