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

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.

Study Overview

• Status: Unknown
• Conditions: Substance-Related Disorders
• Intervention / Treatment: Behavioral: Ho'ouna Pono Drug Prevention Curriculum

• Study Type: Interventional
• Enrollment (Actual): 486
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 14 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days
Recent substance use	Use of alcohol, cigarettes, marijuana, and other drugs over the past month.	30 days

Collaborators and Investigators

• Sponsor: Hawaii Pacific University
• Collaborators: Arizona State University; University of Hawaii
• Investigators: Principal Investigator: Scott K Okamoto, Ph.D., Hawaii Pacific University

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Anticipated): April 15, 2018
• Study Completion (Anticipated): April 15, 2018

Study Registration Dates

• First Submitted: April 11, 2017
• First Submitted That Met QC Criteria: April 13, 2017
• First Posted (Actual): April 18, 2017

Study Record Updates

• Last Update Posted (Actual): April 18, 2017
• Last Update Submitted That Met QC Criteria: April 13, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: prevention; health disparities; Native Hawaiians and other Pacific Islanders
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: 1R01DA037836-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No