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

Primary Purpose

Substance-Related Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ho'ouna Pono Drug Prevention Curriculum
Sponsored by
Hawaii Pacific University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Substance-Related Disorders focused on measuring prevention, health disparities, Native Hawaiians and other Pacific Islanders

Eligibility Criteria

10 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Grades 6-8 in a public or public-charter middle, intermediate, or multi-level school on Hawai'i Island -

Exclusion Criteria:

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Cohort 1

    Cohort 2

    Cohort 3

    Cohort 4

    Arm Description

    Four middle or intermediate schools receiving the Ho'ouna Pono curriculum in Quarter 2, Academic Year (AY) 2016-2017

    Three middle or intermediate schools receiving the Ho'ouna Pono curriculum in Quarter 3, AY 2016-2017

    Three middle or intermediate schools receiving the Ho'ouna Pono curriculum in Quarter 2, AY 2017-2018

    Three middle or intermediate schools receiving the Ho'ouna Pono curriculum in Quarter 3, AY 2017-2018

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    April 11, 2017
    Last Updated
    April 13, 2017
    Sponsor
    Hawaii Pacific University
    Collaborators
    University of Hawaii, Arizona State University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03119129
    Brief Title
    The Development and Evaluation of the Ho'Ouna Pono Drug Prevention Curriculum
    Official Title
    The Development and Evaluation of the Ho'Ouna Pono Drug Prevention
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2016 (Actual)
    Primary Completion Date
    April 15, 2018 (Anticipated)
    Study Completion Date
    April 15, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hawaii Pacific University
    Collaborators
    University of Hawaii, Arizona State University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Substance-Related Disorders
    Keywords
    prevention, health disparities, Native Hawaiians and other Pacific Islanders

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Dynamic wait-listed control group design
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    486 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cohort 1
    Arm Type
    Experimental
    Arm Description
    Four middle or intermediate schools receiving the Ho'ouna Pono curriculum in Quarter 2, Academic Year (AY) 2016-2017
    Arm Title
    Cohort 2
    Arm Type
    Experimental
    Arm Description
    Three middle or intermediate schools receiving the Ho'ouna Pono curriculum in Quarter 3, AY 2016-2017
    Arm Title
    Cohort 3
    Arm Type
    Experimental
    Arm Description
    Three middle or intermediate schools receiving the Ho'ouna Pono curriculum in Quarter 2, AY 2017-2018
    Arm Title
    Cohort 4
    Arm Type
    Experimental
    Arm Description
    Three middle or intermediate schools receiving the Ho'ouna Pono curriculum in Quarter 3, AY 2017-2018
    Intervention Type
    Behavioral
    Intervention Name(s)
    Ho'ouna Pono Drug Prevention Curriculum
    Intervention Description
    Ho'ouna Pono is a school-based, culturally grounded drug prevention curriculum tailored to Native Hawaiian and Pacific Islander youth on Hawai'i Island.
    Primary Outcome Measure Information:
    Title
    Number of participants using drug resistance strategies as measured by the Ho'ouna Pono Survey
    Description
    Strategies (e.g., refuse, explain, avoid, leave) used by youth to resist offers to use drugs in the home, school, or community.
    Time Frame
    30 days
    Title
    Recent substance use
    Description
    Use of alcohol, cigarettes, marijuana, and other drugs over the past month.
    Time Frame
    30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Grades 6-8 in a public or public-charter middle, intermediate, or multi-level school on Hawai'i Island - Exclusion Criteria: -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Scott K Okamoto, Ph.D.
    Organizational Affiliation
    Hawaii Pacific University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    16895043
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23188485
    Citation
    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.
    Results Reference
    background

    Learn more about this trial

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

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