Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03119129
Recruitment Status : Unknown
Verified April 2017 by Hawaii Pacific University.
Recruitment status was:  Active, not recruiting
First Posted : April 18, 2017
Last Update Posted : April 18, 2017
Sponsor:
Collaborators:
University of Hawaii
Arizona State University
Information provided by (Responsible Party):
Hawaii Pacific University

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.


Condition or disease Intervention/treatment Phase
Substance-Related Disorders Behavioral: Ho'ouna Pono Drug Prevention Curriculum Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 486 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Dynamic wait-listed control group design
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Development and Evaluation of the Ho'Ouna Pono Drug Prevention
Actual Study Start Date : September 1, 2016
Estimated Primary Completion Date : April 15, 2018
Estimated Study Completion Date : April 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Abuse

Arm Intervention/treatment
Experimental: Cohort 1
Four middle or intermediate schools receiving the Ho'ouna Pono curriculum in Quarter 2, Academic Year (AY) 2016-2017
Behavioral: Ho'ouna Pono Drug Prevention Curriculum
Ho'ouna Pono is a school-based, culturally grounded drug prevention curriculum tailored to Native Hawaiian and Pacific Islander youth on Hawai'i Island.

Experimental: Cohort 2
Three middle or intermediate schools receiving the Ho'ouna Pono curriculum in Quarter 3, AY 2016-2017
Behavioral: Ho'ouna Pono Drug Prevention Curriculum
Ho'ouna Pono is a school-based, culturally grounded drug prevention curriculum tailored to Native Hawaiian and Pacific Islander youth on Hawai'i Island.

Experimental: Cohort 3
Three middle or intermediate schools receiving the Ho'ouna Pono curriculum in Quarter 2, AY 2017-2018
Behavioral: Ho'ouna Pono Drug Prevention Curriculum
Ho'ouna Pono is a school-based, culturally grounded drug prevention curriculum tailored to Native Hawaiian and Pacific Islander youth on Hawai'i Island.

Experimental: Cohort 4
Three middle or intermediate schools receiving the Ho'ouna Pono curriculum in Quarter 3, AY 2017-2018
Behavioral: Ho'ouna Pono Drug Prevention Curriculum
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 Measures :
  1. 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.

  2. Recent substance use [ Time Frame: 30 days ]
    Use of alcohol, cigarettes, marijuana, and other drugs over the past month.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   10 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03119129


Sponsors and Collaborators
Hawaii Pacific University
University of Hawaii
Arizona State University
Investigators
Layout table for investigator information
Principal Investigator: Scott K Okamoto, Ph.D. Hawaii Pacific University
Publications:
Layout table for additonal information
Responsible Party: Hawaii Pacific University
ClinicalTrials.gov Identifier: NCT03119129    
Other Study ID Numbers: 1R01DA037836-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hawaii Pacific University:
prevention
health disparities
Native Hawaiians and other Pacific Islanders
Additional relevant MeSH terms:
Layout table for MeSH terms
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders