Capacity Builders Inc. Navajo Youth Builders Personal Responsibility Education Innovation Strategies Project

NCT04180358 | Unknown

• 2 other identifiers: 90AP2687-01-0090AP2687-00
• Study Type: interventional
• Target: 834
• Locations: 1 country
• Sites: 1

Brief Summary

Capacity Builders (CBI) will implement the Youth Builders PREIS curriculum Native Students Together Against Negative Decisions (Native STAND) which aims to reduce pregnancies, births, and sexually transmitted infections (STI's) including HIV/AIDS among high-risk youth populations by implementing culturally sensitive curriculum based on Navajo positive youth development. The study has two hypotheses: (1) Do students assigned to the Youth Builders program have a greater chance of abstaining from sexual activity (i.e. oral, vaginal and anal) in the last 3 months as compared to students assigned to the comparison group, measured at 12 month and 18 month follow up? (No vaginal sexual intercourse, report abstinence at 12 and 18 random assignment month follow up); (2) Do students assigned to the Youth Builders program have a greater change of abstaining from sex or practicing safe sex (i.e. using a male or female condom, or other means of birth control if they have sex), than students assigned to the comparison group, measured at 12 and 18 months after random assignment? (No sexual activity or use contraception if engage in sex at 12 month and 18 month follow up.

Conditions

Sexual Abstinence; Responsible Sex

Keywords

Navajo; Sex; Abstain; Culture; Random; Control; Trial; PREIS

Outcome Measures

Primary Outcomes (2)

• Abstaining from sexual activity

  Do students assigned to the Youth Builders program have a greater chance of abstaining from sexual activity (i.e. oral, vaginal and anal) in the last 3 months compared to students assigned to the comparison group at 12 month follow up and 18 month follow up? (No vaginal sexual intercourse, report abstinence at 12 and 18 random assignment month follow up?

  pre test, post test after 27 lessons, short term follow up at 12 months, long term follow up at 18 months

• Abstaining from sex or practicing safe sex

  Do students assigned to the Youth Builders program have a greater chance of abstaining from sex or practicing safe sex (i.e. using a male or female condom, or other means of birth control if they have sex), than students assigned to the comparison group at 12 month follow up and 18 month follow up? (No sexual activity or use contraception if engage in sex at 12 and 18 month follow up)?

  pre test, post test after 27 lessons, short term follow up at 12 months, long term follow up at 18 months

Secondary Outcomes (3)

• Positive impact on participants' assertive communication/negotiation skills

  pre test, post test after 27 lessons, short term follow up at 12 months, long term follow up at 18 months

• Positive impact on the peer to peer communication/discussing expectations habits of participants

  pre test, post test after 27 lessons, short term follow up at 12 months, long term follow up at 18 months

• Positive impact on the family communication/discussing expectations habits of participants

  pre test, post test after 27 lessons, short term follow up at 12 months, long term follow up at 18 months

Other Outcomes (1)

• Greater chance of not becoming (female) or getting (male) the opposite sex pregnant, than students assigned to the comparison group at 12 and 18 months after random assignment

  pre test, post test after 27 lessons, short term follow up at 12 months, long term follow up at 18 months

Study Arms (2)

Impact group

EXPERIMENTAL

The impact group will receive the interventions in the classrooms

Behavioral: Native STAND

Comparison group

PLACEBO COMPARATOR

Comparison group will not receive the intervention

Behavioral: Regular Health/Physical Education Curriculum

Interventions

Native STAND BEHAVIORAL

Native STAND is a comprehensive sexual health curriculum for Native high school students that focuses on sexually transmitted infections, HIV/AIDS, and teen pregnancy prevention, while also covering drug and alcohol use, suicide, and dating violence. Twenty-seven sessions support healthy decision-making through interactive discussions and activities that promote diversity, self-esteem, goals and values, team building, negotiation and refusal skills, and effective communication. Sessions will be conducted in regular Physical Education and/or Health Education classes during classroom/school hours.

Impact group

Regular Health/Physical Education Curriculum BEHAVIORAL

General health and physical education curriculum provided by New Mexico's Public Education Department.

Comparison group

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Between the ages of 14-18
• In grades 9-11
• Provide parental consent and participant assent to participate in the study
• Students in the first two groups will be allowed to participate in the intervention if they are enrolled in the classroom that will be receiving the intervention
• Students in the third group will be allowed to participate in the intervention only if they were part of the study's intervention group

You may not qualify if:

• Not have previously participated in any of the following past CBI Teen Pregnancy
• Prevention programs:
• New Mexico's Department of Health - Wyman's Teen Outreach Program
• Success with Adolescent Goals, inclusive of the Above the Waist Curriculum
• Students in 12th grade
• Study participants from previous cohorts

Sponsors & Collaborators

• Capacity Builders Inc.: lead
• Mathematica Policy Research, Inc.: collaborator
• Family and Youth Services Bureau: collaborator

Study Sites (1)

Capacity Builders Inc.

Farmington, New Mexico, 87401, United States

RECRUITING

Related Links

• Healthy Native Youth
• Capacity Builders
• Navajo Nation Human Research Review Board

MeSH Terms

Conditions

Sexual Abstinence; Safe Sex; Coitus

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Study Officials

• Lois Ritter

  Capacity Builders Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristen Rivas, MS Ed, LADC

CONTACT

775-690-5992; orivasconsulting@charter.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The impact group who is randomly selected will receive the intervention in Physical Education and Health Education classes. The control group will receive the general health and physical education curriculum provided by New Mexico's Public Education Department. No students will take a class twice unless there is a failing grade. Student will be tracked throughout the school year to ensure there is no cross contamination. Additionally, Counselors will work closely with Capacity Builder's program staff to ensure that in between semesters, students will remain in their original group. Program staff will double check at the beginning of each semester to crosswalk student assignments. Additionally, participants in the past Capacity Builder's Inc. Teen Pregnancy Prevention programs will be excluded to minimize the risk that the comparison group participants are exposed to teen pregnancy prevention curricula and, thus, to increase contrast between the intervention and control conditions.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: CBI will implement the Youth Builders PREIS Native STAND curriculum, a comprehensive sexual health curriculum designed for Native high school students that focuses on STI's, HIV/AIDS, and teen pregnancy prevention and covers drug and alcohol use, suicide, and dating violence. Twenty-seven sessions support healthy decision-making through interactive discussions and activities that promote diversity, self-esteem, goals and values, team building, negotiation and refusal skills, and effective communication. Youth Build will enroll 834 youth in 3 cohorts with 42 clusters of 20 students, each who will be randomly assigned to an impact or a comparison group. Students will complete pre and post survey questionnaires and be provided incentives to maintain program participation. The program will have 4 staff: Project Director, Project Coordinator, and 2 Prevention Educations responsible for collecting data and tracking progress as well as implementing the curriculum

Study Record Dates

• First Submitted: November 22, 2019
• First Posted: November 27, 2019
• Study Start: October 24, 2017
• Primary Completion: February 1, 2021
• Study Completion: September 29, 2021
• Last Updated: November 27, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)