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Substance-Related DisordersNCT03119129

The Development and Evaluation of the Ho'Ouna Pono Drug Prevention Curriculum

A study testing Ho'ouna Pono Drug Prevention Curriculum in people with Substance-Related Disorders, run by Hawaii Pacific University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purposes of this study are to complete the development of a video-enhanced, school-based drug prevention program for rural Hawaiian youth (Ho'ouna Pono) using community-based participatory research principles and practices, and to test the efficacy and adoption of the full intervention across all… Read more about this study

Who is it for?
Ages 10 to 14 yearsHealthy volunteers can take part
Conditions the study is for
Substance-Related Disorders
What is being tested?
Ho'ouna Pono Drug Prevention Curriculum
Could I receive a placebo?
No, everyone receives an active treatment
How many people
486 participants
Where
No sites listed yet
Study dates
1 Sep 2016to 15 Apr 2018
Phase
Interventional
Are there results?
None posted in the registry

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 10 to 14 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

None listed.

Who cannot join

  • -

About this study

Official title: The Development and Evaluation of the Ho'Ouna Pono Drug Prevention

The purposes of this study are to complete the development of a video-enhanced, school-based drug prevention program for rural Hawaiian youth (Ho'ouna Pono) using community-based participatory research principles and practices, and to test the efficacy and adoption of the full intervention across all middle/intermediate schools on Hawai'i Island. These purposes will be accomplished through three specific aims. AIM 1 (Year 1) is to complete the Ho'ouna Pono drug prevention curriculum initially developed and validated in a NIDA-funded pilot/feasibility study (R34 DA031306). To date, five professionally filmed video vignettes depicting drug-related problem situations specific to rural Hawaiian youth and seven interactive classroom lessons have been created, implemented in randomly selected intervention schools, and preliminarily evaluated using a pre-test, post-test control group design. Aim 1 enhances and builds upon this work by producing two new video vignettes, re-editing a "Behind the Scenes" video, developing new classroom curricular components, and synthesizing the new content with the existing curriculum. AIM 2 (Years 2-3) is to evaluate the fully conceived curriculum across all middle/intermediate schools on Hawai'i Island (N = 15) using a dynamic wait-listed control group design (Brown, Wyman, Guo, \& Peña, 2006). Using this design, schools will be randomly assigned to four cohorts, and cohorts will be randomly assigned to receive the curriculum at designated times staggered across the two-year evaluation period. All participating youth will be measured at six designated time points across the two-year evaluation period. Because of the staggered implementation of the curriculum, intervention effects will differ by cohort, and earlier time points will include control schools for the initial cohorts receiving the intervention. All participating youth will receive pre-tests prior to curriculum implementation and post-tests upon curriculum completion, with youth attending schools in Cohorts 1-3 receiving follow-up evaluations. AIM 3 (Year 4) is to assess community, systemic, and curricular factors related to the implementation, adoption, and sustainability of the curriculum within public middle/intermediate schools on Hawai'i Island.

The present study is the result of seven consecutive years of NIDA-funded pre-prevention and translational pilot/feasibility drug prevention research focused on rural Hawaiian youth and communities. The overall outcome of this study will be an empirically supported, culturally grounded drug prevention curriculum relevant to Native Hawaiian and Pacific Islander youth. This study addresses the lack of prevention interventions for Native Hawaiians and other Pacific Islanders (NHOPIs) and indigenous youth populations, and directly contributes to the development of an indigenous prevention science (Okamoto, Helm, et al., 2014). It has implications for informing indigenous, Pacific Islander, and rural health disparities and health equity promotion.

Being tested
Ho'ouna Pono Drug Prevention Curriculum
Keywords
prevention, health disparities, Native Hawaiians and other Pacific Islanders
Medical subject headings
Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ho'ouna Pono Drug Prevention CurriculumBehavioural

    Ho'ouna Pono is a school-based, culturally grounded drug prevention curriculum tailored to Native Hawaiian and Pacific Islander youth on Hawai'i Island.

Study groups in NCT03119129
Study groupRoleWhat they receive
Cohort 1ExperimentalFour middle or intermediate schools receiving the Ho'ouna Pono curriculum in Quarter 2, Academic Year (AY) 2016-2017
Receives: Behavioral: Ho'ouna Pono Drug Prevention Curriculum
Cohort 2ExperimentalThree middle or intermediate schools receiving the Ho'ouna Pono curriculum in Quarter 3, AY 2016-2017
Receives: Behavioral: Ho'ouna Pono Drug Prevention Curriculum
Cohort 3ExperimentalThree middle or intermediate schools receiving the Ho'ouna Pono curriculum in Quarter 2, AY 2017-2018
Receives: Behavioral: Ho'ouna Pono Drug Prevention Curriculum
Cohort 4ExperimentalThree middle or intermediate schools receiving the Ho'ouna Pono curriculum in Quarter 3, AY 2017-2018
Receives: Behavioral: Ho'ouna Pono Drug Prevention Curriculum

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants using drug resistance strategies as measured by the Ho'ouna Pono Survey

    Strategies (e.g., refuse, explain, avoid, leave) used by youth to resist offers to use drugs in the home, school, or community.

    Measured: 30 days

  2. Recent substance use

    Use of alcohol, cigarettes, marijuana, and other drugs over the past month.

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2017
  2. Study start1 Sep 2016
  3. Primary completion15 Apr 2018 (estimated)
  4. Study completion15 Apr 2018 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Model description
Dynamic wait-listed control group design
Masking
None (open label)
Enrolment
486 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03119129
Sponsor's protocol ID
1R01DA037836-01A1
Status last verified
Apr 2017
First submitted
11 Apr 2017
Last updated
18 Apr 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Brown CH, Wyman PA, Guo J, Pena J. Dynamic wait-listed designs for randomized trials: new designs for prevention of youth suicide. Clin Trials. 2006;3(3):259-71. doi: 10.1191/1740774506cn152oa.

    PubMed 16895043
  • Okamoto SK, Helm S, Pel S, McClain LL, Hill AP, Hayashida JK. Developing empirically based, culturally grounded drug prevention interventions for indigenous youth populations. J Behav Health Serv Res. 2014 Jan;41(1):8-19. doi: 10.1007/s11414-012-9304-0.

    PubMed 23188485

Questions about this trial

What is this clinical trial studying?

A study testing Ho'ouna Pono Drug Prevention Curriculum in people with Substance-Related Disorders, run by Hawaii Pacific University.

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 0 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: status not confirmed, as of the sponsor's last update on 18 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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?

Number of participants using drug resistance strategies as measured by the Ho'ouna Pono Survey (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03119129, which also lists 2 linked publications.

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 18 Apr 2017.

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