CClinicalTrials.gg
Status unknownNCT04180358PREISUpdated Nov 27, 2019

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

An interventional study of Native STAND and Regular Health/Physical Education Curriculum in Sexual Abstinence and Responsible Sex, sponsored by Capacity Builders Inc.. Status unknown at 1 site in United States. Open to participants aged 14 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-27.

Sponsored by Capacity Builders Inc. · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Nov 2019), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 2 years after the study started (first participant enrolled Oct 2017, registered Nov 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
834
Allocation
Randomized
Ages
14 Years to 18 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Sexual Abstinence
  • Responsible Sex

Keywords

  • Navajo
  • Sex
  • Abstain
  • Culture
  • Random
  • Control
  • Trial
  • PREIS
03

In context

Lead sponsor

This is the only study on the registry with Capacity Builders Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
834 participants (estimated)

Study arms

  • Experimental
    Impact group

    The impact group will receive the interventions in the classrooms

    Behavioral: Native STAND

  • Placebo comparator
    Comparison group

    Comparison group will not receive the intervention

    Behavioral: Regular Health/Physical Education Curriculum

Interventions

  • BehavioralNative 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.

  • BehavioralRegular Health/Physical Education Curriculum

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

06

What researchers measure

Primary outcomes

  1. 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?

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

  2. 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)?

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

Secondary outcomes

  1. 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?

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

  2. 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?

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

  3. 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?

    Time frame: 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

    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?

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

07

Study locations

1 of 1 sites recruiting
  • Capacity Builders Inc.
    Farmington, New Mexico 87401, United States
    Recruiting
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 27, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04180358
Lead sponsor
Capacity Builders Inc.
Collaborators
Mathematica Policy Research, Inc., Family and Youth Services Bureau
Responsible party
Sponsor
First posted
Nov 27, 2019
Start date
Oct 24, 2017
Primary completion
Feb 1, 2021 (estimated)
Completion
Sep 29, 2021 (estimated)
Last update
Nov 27, 2019

Study contacts

Kristen Rivas, MS Ed, LADC
Contact
orivasconsulting@charter.net
775-690-5992
Lois Ritter
principal investigator · Capacity Builders Inc.

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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