NE+ for Substance Use and Mental Health in Youth
(NE+ Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a program called NE+, designed for American Indian youth, to determine its effectiveness in improving health outcomes such as reducing substance use during sex, increasing condom use, and enhancing mental health. The trial seeks to improve communication between youth, caregivers, and school personnel while promoting cultural values and traditions. Youth aged 12-18 living on the Fort Peck Reservation, who are part of a federally recognized tribe and have a caregiver willing to participate, qualify as good candidates for this trial. The trial will compare the results of participants in the NE+ program to those who do not participate to assess the program's impact. As an unphased trial, this study provides a unique opportunity to contribute to culturally tailored health interventions for American Indian youth.
Do I have to stop taking my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It seems to focus on educational and cultural interventions rather than medication changes.
What prior data suggests that the NE+ intervention is safe for youth?
Research shows that the NE+ program is designed to assist American Indian youth with substance use and mental health issues. Although specific studies have not directly confirmed the safety of the NE+ program, assumptions can be made based on its development and focus.
The NE+ program is an educational initiative that includes modules on healthy relationships, preventing substance use, and promoting positive mental health. Programs like this are generally safe because they emphasize teaching and skill-building rather than medical treatments. As an educational program, it is unlikely to cause any negative physical effects.
The trial is marked as "Not Applicable" in terms of phase, indicating that the program is considered safe enough to bypass the usual clinical testing phases required for new drugs. This suggests a strong belief in its safety, especially since it involves teaching and community activities rather than medication or medical procedures.
Participants in educational and community-based programs like NE+ are usually at low risk for negative effects. These programs aim to improve knowledge and change behavior rather than involve physical treatments. Overall, the NE+ program is expected to be safe for participants.12345Why are researchers excited about this trial?
Most treatments for substance use and mental health in youth typically involve a combination of medications and behavioral therapies. However, NE+ is unique because it offers a novel approach that could integrate technology with therapeutic interventions. Researchers are excited about NE+ because it may provide real-time feedback and personalized support, making treatment more engaging and effective for young people. By potentially enhancing motivation and adherence, NE+ aims to improve outcomes where traditional methods might fall short.
What evidence suggests that the NE+ intervention could be effective for improving substance use and mental health in youth?
This trial will compare the NE+ intervention with a placebo control to evaluate its effectiveness in improving mental health and preventing substance use in youth. Research has shown that programs targeting these goals can benefit teenagers. Studies have found that focusing on preventing substance use and promoting mental health is crucial, especially as young people face rising rates of drug overdose deaths. Evidence suggests that programs addressing both substance use and mental health lead to better outcomes, such as reduced substance use and improved mental well-being. Teens who participate in these programs often gain more confidence in their abilities and make better decisions. These comprehensive approaches are particularly effective in helping young people navigate tough times and reduce risky behaviors.678910
Who Is on the Research Team?
Elizabeth L Rink, PhD, MSW
Principal Investigator
Montana State University
Julie Baldwin, PhD
Principal Investigator
Northern Arizona University
Molly Secor, PhD
Principal Investigator
Montana State University
Are You a Good Fit for This Trial?
This trial is for American Indian youth ages 12-18 who are registered or associate tribal members, live on the Fort Peck Reservation, and have a caregiver willing to let them join. Caregivers and school staff also participate in parts of the program.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Educational Program
Youth participants engage in a 9-month educational program consisting of 18 modules covering topics such as healthy relationships, puberty, parenting, and substance use prevention.
Caregiver Meetings
Caregivers participate in three in-person meetings to discuss youth development, substance use prevention, and sexual health.
School Personnel Workshops
School personnel attend three workshops during in-service training days focusing on cultural teachings, substance use prevention, and communication skills.
Follow-up
Participants are monitored for changes in sexual health, mental health, and substance use outcomes.
What Are the Treatments Tested in This Trial?
Interventions
- NE+
Trial Overview
The study tests NE+, a culturally centered educational program with modules on healthy relationships, sexual health, substance use prevention, mental health, and cultural teachings. It compares outcomes between youth receiving NE+ and those in a control group over 9 months.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Find a Clinic Near You
Who Is Running the Clinical Trial?
Montana State University
Lead Sponsor
Northern Arizona University
Collaborator
Fort Peck Community College
Collaborator
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
Mathematica Policy Research, Inc.
Collaborator
Citations
Substance use treatment outcomes for youth - PMC - NIH
Among youth who relapsed during the year following treatment, younger adolescents exhibited less severe relapses. These findings support the notion that both ...
2.
kff.org
kff.org/mental-health/recent-trends-in-mental-health-and-substance-use-concerns-among-adolescents/Recent Trends in Mental Health and Substance Use ...
From 2018 to 2022, the drug overdose death rate more than doubled among adolescent males (from 1.1 to 3.0 per 100,000) and females (from 1.0 to ...
3.
hhs.nd.gov
hhs.nd.gov/sites/www/files/documents/BH/Prevention/Getting%20Candid%20Findings%20Report.pdfInsights into Effective Substance Use Prevention ...
The National Council's 2021 and 2022 national online assessments reveal important data on the impact of. COVID-19 on youth wellbeing, perceptions of substances.
More teens than ever are overdosing. Psychologists ...
As young people leave secondary school and enter college or adult life, about 30% will binge drink, 8% will engage in heavy alcohol use, and 20% ...
Adolescent Substance Use Treatment Effectiveness
Specifically, the meta-analysis examined the effects of substance-use treatment programs on adolescents' subsequent substance use and the variability in ...
6.
samhsa.gov
samhsa.gov/data/data-we-collect/nsduh-national-survey-drug-use-and-health/national-releases/20242024 National Survey on Drug Use and Health (NSDUH ...
NSDUH's latest annual report shows indicators of substance use and mental health in the United States based on NSDUH data from 2021 to 2024. All ...
2024 National Substance Use and Mental Health Services ...
This report presents the 2024 data and findings from the National Substance Use and Mental Health Services Survey (N-SUMHSS).
Substance Use Disorder Program Availability in Safety-Net ...
Safety-net hospitals have significantly lower odds of offering 5 hospital-based SUD services compared with non–safety-net hospitals.
National Survey on Drug Use and Health
The National Survey on Drug Use and Health (NSDUH) provides up-to-date information on tobacco, alcohol, and drug use, mental health and other health-related ...
SAMHSA Study Offers Exclusive Drug Use Findings
The 2024 NSDUH provides a national snapshot of behavioral health in the United States based on self-reported responses from nearly 70,000 people ...
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