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Sexual BehaviorNCT06485284

Evaluating the El Camino Program

A study testing El Camino and Life skills program in people with Sexual Behavior and Adolescent Behavior, run by Child Trends at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 14 to 21 yearsHealthy volunteers can take part
Conditions the study is for
Sexual Behavior, Adolescent Behavior
What is being tested?
El Camino and Life skills program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
746 participants
Where
2 sitesUnited States
Study dates
17 Feb 2021to 25 Jan 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 21 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Identity, Inc.

    Gaithersburg, Maryland, 20877

  • Montgomery County Public Schools

    Rockville, Maryland, 20850

Other trials in United States

About this study

Official title: 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?
Read more

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
Being tested
El Camino, Life skills program
Medical subject headings
Sexual Behavior, Adolescent Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • El CaminoBehavioural

    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 programBehavioural

    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.

Study groups in NCT06485284
Study groupRoleWhat they receive
El CaminoExperimentalAdolescents receiving the intervention/treatment - El Camino.
Receives: Behavioral: El Camino
ControlOtherAdolescents receiving the control - alternative life skills program.
Receives: Behavioral: Life skills program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Immediately following program completion, 12 months after program completion

  2. 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

    Measured: Immediately following program completion, 12 months after program completion

  3. 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

    Measured: Immediately following program completion, 12 months after program completion

  4. 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

    Measured: Immediately following program completion, 12 months after program completion

Secondary outcomes (15)

  1. 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)

    Measured: Immediately following program completion, 12 months after program completion

  2. 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)

    Measured: Immediately following program completion, 12 months after program completion

  3. 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

    Measured: Immediately following program completion, 12 months after program completion

  4. 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)

    Measured: Immediately following program completion, 12 months after program completion

  5. 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)

    Measured: Immediately following program completion, 12 months after program completion

  6. 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)

    Measured: Immediately following program completion, 12 months after program completion

  7. 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)

    Measured: Immediately following program completion, 12 months after program completion

  8. 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

    Measured: Immediately following program completion, 12 months after program completion

  9. 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)

    Measured: Immediately following program completion, 12 months after program completion

  10. Confidence going to a clinic to get contraception

    Response options on 4-point scale

    from "not at all confident" to

    "completely confident"

    Measured: Immediately following program completion, 12 months after program completion

  11. 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)

    Measured: Immediately following program completion, 12 months after program completion

  12. 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)

    Measured: Immediately following program completion, 12 months after program completion

  13. Confidence stating and asking for consent

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

    all other responses)

    Measured: Immediately following program completion, 12 months after program completion

  14. 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

    Measured: Immediately following program completion, 12 months after program completion

  15. 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

    Measured: Immediately following program completion, 12 months after program completion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2024
  2. Study start17 Feb 2021
  3. Primary completion25 Jan 2024
  4. Study completion25 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
746 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06485284
Sponsor's protocol ID
TP2AH000077
Status last verified
Jun 2024
First submitted
26 Jun 2024
Last updated
3 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 37351668

  • McConnell K, Ibrahimi S, Yumiseva M, Shan S, Lewin A. Impacts of El Camino on Latino Youth's Sexual Health: A Cluster Randomized Controlled Trial. Health Educ Behav. 2026 Jun;53(3):249-259. doi: 10.1177/10901981251375467. Epub 2025 Nov 3.

    PubMed 41178411

  • McConnell K, Ibrahimi S, Yumiseva M, Shan S, Lewin A. Short-Term Impacts of a School-Based Teen Pregnancy Prevention Program for Latino Youth: a Cluster Randomized Trial. Prev Sci. 2025 Jul;26(5):716-726. doi: 10.1007/s11121-025-01805-y. Epub 2025 Apr 14.

    PubMed 40229508

Questions about this trial

What is this clinical trial studying?

A study testing El Camino and Life skills program in people with Sexual Behavior and Adolescent Behavior, run by Child Trends at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ever had penis-in-vagina sex (time frame: Immediately following program completion, 12 months after program completion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06485284, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.

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