Evaluating the El Camino Program

NCT ID: NCT06485284

Last Updated: 2024-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

746 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-17

Study Completion Date

2024-01-25

Brief Summary

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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

Detailed Description

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Conditions

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Sexual Behavior Adolescent Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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El Camino

Adolescents receiving the intervention/treatment - El Camino.

Group Type EXPERIMENTAL

El Camino

Intervention Type 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.

Control

Adolescents receiving the control - alternative life skills program.

Group Type OTHER

Life skills program

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Identity, Inc.

UNKNOWN

Sponsor Role collaborator

University of Maryland

OTHER

Sponsor Role collaborator

Child Trends

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Manlove

Senior Research Scholar

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Identity, Inc.

Gaithersburg, Maryland, United States

Site Status

Montgomery County Public Schools

Rockville, Maryland, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 37351668 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40229508 (View on PubMed)

Other Identifiers

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TP2AH000077

Identifier Type: -

Identifier Source: org_study_id

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