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

Sexual Abstinence Clinical Trial

— PREIS  

Official title:

Capacity Builders Inc. Navajo Youth Builders Personal Responsibility Education Innovation Strategies Project Effectively Educating Navajo Youth on the Prevention of Adolescent Pregnancy, Sexually Transmitted Infections, and HIV/AIDS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04180358
• Other study ID #: 90AP2687-01-00
• Secondary ID: 90AP2687-00
• Status: Recruiting
• Phase: N/A
• Start date: October 24, 2017
• Est. completion date: September 29, 2021

Study information

• Verified date: November 2019
• Source: Capacity Builders Inc.
• Contact: Kristen Rivas, MS Ed, LADC
• Phone: 775-690-5992
• Email: orivasconsulting[@]charter.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Capacity Builders (CBI) will implement the Youth Builders PREIS curriculum Native STAND, recruiting Navajo youth in grades 9-11 and between the ages 14-18 who attend school in the Consolidated School District in New Mexico. Using the Theory of Reasoned Action as a theoretical framework, the curriculum will be administered in classrooms over 27 sessions lasting 45 minutes. The curriculum will entail lessons conducted in either Physical Education or Health Classes and youth will be randomly assigned to two groups by the local program evaluator. Youth will be required to obtain signed consent and assent forms prior to participating in the intervention program. Youth will complete pre and post surveys to measure program outcomes. Random assignment will be conducted for the impact and comparison groups by being placed into a pool; students will be blindly pulled to become the impact group. Groups will be stratified to ensure balance between treatment and comparison groups. Quarterly evaluation reports (QERs) and an annual evaluation report will be provided to the Action Team for review.

Capacity Builder's Inc. (CBI) Youth Builders PREIS program seeks to test a modification of the Native STAND curriculum in Northwest New Mexico with at least 834 Navajo teens and 3 cohorts. The curriculum is intended to reduce pregnancies, births, and STI's including HIV/AIDS among high-risk youth populations by implementing culturally sensitive curriculum based on Navajo positive youth development. Additional curriculum of adulthood preparation subjects will increase participant knowledge in the areas of: healthy relationships, adolescent development, communication skills, healthy life skills. Youth Builders will be delivered within the traditional school day, embedded into regularly scheduled learning time. Presented once each week for 27 weeks over a 36-week school year, Youth Builders will reach students where they are, overcoming many challenges associated with retention. The project will support a Randomized Controlled Experimental Design. CBI will create valuable resources to support Youth Builders replication nationwide, including a comprehensive Youth Builders Blueprint, describing all action steps taken to achieve goals and objectives. In addition to action steps, the Youth Builders Blueprint will include: program curriculum; curricular map; training materials; sample parent consent forms; sample referral procedures / policies; staff training schedules; sample partnership agreements; Action Team meeting minutes,QERs, and annual evaluation reports The Youth Builders Blueprint will be available in both print and online format, and will be widely disseminated throughout the CBI network of non-profit agencies, Tribes, and school districts across the United States. Conference presentation will be ongoing at state and national conferences.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 834
• Est. completion date: September 29, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 18 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Responsible Sex
• Sexual Abstinence

Intervention

Behavioral:
• Native STAND
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.
• Regular Health/Physical Education Curriculum
General health and physical education curriculum provided by New Mexico's Public Education Department.

Locations

Country	Name	City	State
United States	Capacity Builders Inc.	Farmington	New Mexico

Sponsors (3)

Lead Sponsor	Collaborator
Capacity Builders Inc.	Family and Youth Services Bureau, Mathematica Policy Research, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Do students assigned to the Youth Builders program have a 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
Primary	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
Primary	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	Positive impact on participants' assertive communication/negotiation skills	To what degree does the Youth Builders curriculum have a 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
Secondary	Positive impact on the peer to peer communication/discussing expectations habits of participants	To what degree does the Youth Builders curriculum have a 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
Secondary	Positive impact on the family communication/discussing expectations habits of participants	To what degree does the Youth Builders curriculum have a 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

External Links

•   Capacity Builders
•   Family and Youth Services Bureau
•   Healthy Native Youth
•   Native STAND (Students Together Against Negative Decisions)
•   Navajo Nation Human Research Review Board