AdolescentNCT06971003
Mohala Na Pua: Community-driven Drug Prevention
A study testing Ho'ouna Pono in people with Adolescent, run by Judge Baker Children's Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent
- What is being tested?
- Ho'ouna Pono
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2025to 31 May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All students in intermediate schools within the district
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Baker Center for Children and Families
Boston, Massachusetts, 02120
Hawaii State Department of Education - Windward District
Kaneohe, Hawaii, 96744
About this study
Official title: Community-driven Drug Prevention Implementation Strategies for Native Hawaiian and Pacific Islander Youth in Rural Hawaii
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.
Read the 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?
- Conditions
- Adolescent
- Being tested
- Ho'ouna Pono
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ho'ouna PonoBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Ho'ouna Pono | Experimental | Participants will receive the substance use prevention intervention consisting of (1) a modular classroom curriculum and (2) social media content. Receives: Behavioral: Ho'ouna Pono |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 10 months
Secondary outcomes (2)
30-day resistance skill use
Self-reported resistance skill use to various offers from family and peers at baseline and post intervention. Respondents indicate the extent to which they would use resistance skills in categories including definitely not, probably not, not sure, probably, and definitely. Respondents also indicate how often they have used this response in the last 30 days in categories including never, once, 2-3 times, 4 times, more than 4 times, or not offered.
Measured: Through study completion, an average of 10 months
Risk assessment
Self-reported risk assessment to drug offers at baseline and post intervention. Respondents indicate the extent to which factors might impact their decision in rejecting drug offers in categories including not at all, maybe a little, neutral, a little, a lot.
Measured: Through study completion, an average of 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start1 Apr 2025
- Primary completion31 May 2030 (estimated)
- Study completion31 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdolescentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- 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).
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Judge Baker Children's Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Kelsie Okamura, Judge Baker Children's Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06971003
- Sponsor's protocol ID
- IRD003
- Other IDs
- DP1DA061311
- Status last verified
- May 2025
- First submitted
- 10 Apr 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-driven Drug Prevention Implementation Strategies for Native Hawaiian and Pacific Islander Youth in Rural Hawaii
- ClinicalTrials.gov ID
- NCT06971003
- Acronym / sponsor ID
- IRD003
- Conditions
- Adolescent
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Judge Baker Children's CenterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 May 2030 (estimated)
- Study completion
- 31 May 2030 (estimated)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- 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).
| Arm | Type | Receives |
|---|---|---|
| Ho'ouna Pono | Experimental | Behavioral: Ho'ouna PonoParticipants will receive the substance use prevention intervention consisting of (1) a modular classroom curriculum and (2) social media content. |
Who may qualify
- Ages
- 11 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All students in intermediate schools within the district
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ho'ouna PonoAn 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. | Behavioural | Ho'ouna Pono |
Primary outcome
30-day drug use
Time frame: Through study completion, an average of 10 months
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.
30-day prosocial activities
Time frame: Through study completion, an average of 10 months
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.
30-day drug offers
Time frame: Through study completion, an average of 10 months
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.
2 secondary outcomes
30-day resistance skill use
Time frame: Through study completion, an average of 10 months
Risk assessment
Time frame: Through study completion, an average of 10 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Mohala Na Pua websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ho'ouna Pono in people with Adolescent, run by Judge Baker Children's Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day drug use (time frame: Through study completion, an average of 10 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.