Clinical trial NCT06971003: Mohala Na Pua: Community-driven Drug Prevention
Official title: Community-driven Drug Prevention Implementation Strategies for Native Hawaiian and Pacific Islander Youth in Rural Hawaii
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Adolescent
Lead sponsor: Judge Baker Children's Center
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2025-05-14
Enrollment: 130
Sex: ALL
Minimum age (years): 11
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Enrolled students will participate in activities to enhance the implementation of the prevention program in their school. Schools are sequentially recruited each year (i.e., one school will participate per year).
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to learn if a substance use prevention intervention decreases substance use, increases resistance skill use, and decreases substance use risk in intermediate school students. The main questions it aims to answer:

Does the intervention decrease 30-day substance use? Does the intervention increase 30-day resistance skill use?

Participants will be asked to participate in the intervention and provide their self-reported answers to behavioral questions before and after the intervention.

Detailed description: Among all ethnic groups in Hawai'i, Native Hawaiian and Pacific Islander youth report the highest rates of substance use, and need for substance use treatment . With the high prevalence of substance use and health disparities among Native Hawaiian, and Pacific Islander (NHPI) communities, research continues to emphasize the need to implement evidence-based prevention programs for youth that are culturally adapted or grounded for indigenous populations. The current five phase, mixed-methods design study aims to use a community-based participatory research approach to implement a culturally grounded, school-based substance use prevention program, Ho'ouna Pono, for NHPI youth across middle/intermediate schools (6th - 8th) in the Windward District of Hawai'i State Department of Education (HIDOE). The current program, Ho'ouna Pono, is a nine-lesson, culturally grounded, video-based, and teacher-delivered substance use prevention curriculum developed on Hawai'i island to build drug resistance skills for middle school students (see Table 3 for specific lesson content). There are three additional modules that are currently being developed. Past program efficacy trials have found statistically significant changes in cigarette/e-cigarette and hard drug use among Native Hawaiian youth on Hawai'i Island, therefore, the research team is interested in evaluating if the intervention will have the same clinical outcome effect with NHPI youth on other islands.

The study focuses on understanding youth substance use and resistance skills prior to and upon completion of the culturally grounded substance use prevention curriculum. The team will be evaluating the program's effects on students' resistance skills development, drug use behaviors, as well as other clinical outcomes data of the intervention, such as drug use behaviors and the utilization of resistance skills.

The overarching research questions are:

* What changes in drug use behaviors are observed among students upon completion of the program?
* What drug resistance strategies did students use upon completion of the program?

Eligibility criteria: Inclusion Criteria:

* All students in intermediate schools within the district

Exclusion Criteria:

* None

Primary outcomes:
measure: 30-day drug use
timeFrame: Through study completion, an average of 10 months
measure: 30-day prosocial activities
timeFrame: Through study completion, an average of 10 months
measure: 30-day drug offers
timeFrame: Through study completion, an average of 10 months
Secondary outcomes:
measure: 30-day resistance skill use
timeFrame: Through study completion, an average of 10 months
measure: Risk assessment
timeFrame: Through study completion, an average of 10 months
Other outcomes:
Locations:
city: Kaneohe
country: United States
facility: Hawaii State Department of Education - Windward District
state: Hawaii
city: Boston
country: United States
facility: The Baker Center for Children and Families
state: Massachusetts
Study officials:
References: