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

• ClinicalTrials.gov Identifier: NCT03119129
• Recruitment Status: Unknown
• First Posted: April 18, 2017
• Last Update Posted: April 18, 2017
• Sponsor: Hawaii Pacific University
• Collaborators: University of Hawaii; Arizona State University
• Information provided by (Responsible Party): Hawaii Pacific University

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.

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

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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:

-

Contacts and Locations

Sponsors and Collaborators

Hawaii Pacific University

University of Hawaii

Arizona State University

Investigators

• Principal Investigator: Scott K Okamoto, Ph.D.; Hawaii Pacific University

More Information

Publications:

Brown CH, Wyman PA, Guo J, Peña J. Dynamic wait-listed designs for randomized trials: new designs for prevention of youth suicide. Clin Trials. 2006;3(3):259-71.

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.

• 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
• Last Update Posted: April 18, 2017
• Last Verified: April 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders