NCT06971003

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
49mo left

Started Apr 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Apr 2025May 2030

Study Start

First participant enrolled

April 1, 2025

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 14, 2025

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2030

Last Updated

May 14, 2025

Status Verified

May 1, 2025

Enrollment Period

5.2 years

First QC Date

April 10, 2025

Last Update Submit

May 9, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • 30-day drug use

    Self-reported 30-day drug use at baseline and post intervention. Respondents indicate their 30-day behavior in categories including never, only once, a few times, once a week, and almost every day.

    Through study completion, an average of 10 months

  • 30-day prosocial activities

    Self-reported 30-day prosocial activities at baseline and post intervention. Respondents indicate their 30-day behavior in categories including never, only once, a few times, once a week, and almost every day.

    Through study completion, an average of 10 months

  • 30-day drug offers

    Self-reported 30-day drug offers at baseline and post intervention. Respondents indicate their 30-day behavior in categories including never, only once, a few times, once a week, and almost every day.

    Through study completion, an average of 10 months

Secondary Outcomes (2)

  • 30-day resistance skill use

    Through study completion, an average of 10 months

  • Risk assessment

    Through study completion, an average of 10 months

Study Arms (1)

Ho'ouna Pono

EXPERIMENTAL

Participants will receive the substance use prevention intervention consisting of (1) a modular classroom curriculum and (2) social media content.

Behavioral: Ho'ouna Pono

Interventions

Ho'ouna PonoBEHAVIORAL

An efficacious culturally grounded substance use prevention intervention developed and tested with Hawaii Island students. Teachers deliver the 11 lesson program through 30-45 minute weekly sessions. The modular intervention can be customized to students by teachers.

Ho'ouna Pono

Eligibility Criteria

Age11 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • All students in intermediate schools within the district

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hawaii State Department of Education - Windward District

Kaneohe, Hawaii, 96744, United States

Location

The Baker Center for Children and Families

Boston, Massachusetts, 02120, United States

Location

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Implementation Researcher

Study Record Dates

First Submitted

April 10, 2025

First Posted

May 14, 2025

Study Start

April 1, 2025

Primary Completion (Estimated)

May 31, 2030

Study Completion (Estimated)

May 31, 2030

Last Updated

May 14, 2025

Record last verified: 2025-05

Locations