Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-30 @ 8:13 PM
Study NCT ID:
NCT06971003
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-14
First Post:
2025-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mohala Na Pua: Community-driven Drug Prevention
Sponsor:
Judge Baker Children's Center
Organization:
Study Overview
Official Title:
Community-driven Drug Prevention Implementation Strategies for Native Hawaiian and Pacific Islander Youth in Rural Hawaii
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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?
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?
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| DP1DA061311 | NIH | None | https://reporter.nih.gov/quic… | View |