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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
- Conditions
- Substance-Related Disorders
- 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 group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Four 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 2 | Experimental | Three 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 3 | Experimental | Three 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 4 | Experimental | Three 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.
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
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.
- First posted18 Apr 2017
- Study start1 Sep 2016
- Primary completion15 Apr 2018 (estimated)
- Study completion15 Apr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Substance-Related DisordersStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Dynamic wait-listed control group design
- Masking
- None (open label)
- Enrolment
- 486 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hawaii Pacific University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Hawaii, Arizona State University
- Responsible party
- Sponsor
- Investigators
- Scott K Okamoto, Ph.D., Principal investigator, Hawaii Pacific University
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 16895043Okamoto 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development and Evaluation of the Ho'Ouna Pono Drug Prevention
- ClinicalTrials.gov ID
- NCT03119129
- Acronym / sponsor ID
- 1R01DA037836-01A1
- Conditions
- Substance-Related Disorders
- Keywords
- prevention, health disparities, Native Hawaiians and other Pacific Islanders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 486 participants (actual)
- Lead sponsor
- Hawaii Pacific UniversityUniversity, hospital or other
- Collaborators
- University of Hawaii, Arizona State University
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 15 Apr 2018 (estimated)
- Study completion
- 15 Apr 2018 (estimated)
- First posted
- 18 Apr 2017 (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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Dynamic wait-listed control group design
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Behavioral: Ho'ouna Pono Drug Prevention CurriculumFour middle or intermediate schools receiving the Ho'ouna Pono curriculum in Quarter 2, Academic Year (AY) 2016-2017 |
| Cohort 2 | Experimental | Behavioral: Ho'ouna Pono Drug Prevention CurriculumThree middle or intermediate schools receiving the Ho'ouna Pono curriculum in Quarter 3, AY 2016-2017 |
| Cohort 3 | Experimental | Behavioral: Ho'ouna Pono Drug Prevention CurriculumThree middle or intermediate schools receiving the Ho'ouna Pono curriculum in Quarter 2, AY 2017-2018 |
| Cohort 4 | Experimental | Behavioral: Ho'ouna Pono Drug Prevention CurriculumThree middle or intermediate schools receiving the Ho'ouna Pono curriculum in Quarter 3, AY 2017-2018 |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 Pono Drug Prevention CurriculumHo'ouna Pono is a school-based, culturally grounded drug prevention curriculum tailored to Native Hawaiian and Pacific Islander youth on Hawai'i Island. | Behavioural | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
Primary outcome
Number of participants using drug resistance strategies as measured by the Ho'ouna Pono Survey
Time frame: 30 days
Strategies (e.g., refuse, explain, avoid, leave) used by youth to resist offers to use drugs in the home, school, or community.
Recent substance use
Time frame: 30 days
Use of alcohol, cigarettes, marijuana, and other drugs over the past month.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2017.
- Background: PubMed 16895043Brown 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.
- Background: PubMed 23188485Okamoto 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.
- Individual participant dataSharing planned: No
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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.
Scott K Okamoto, Ph.D. principal investigator
Hawaii Pacific University
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.