Clinical trial NCT03119129: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Substance-Related Disorders
Keywords: prevention
health disparities
Native Hawaiians and other Pacific Islanders
Lead sponsor: Hawaii Pacific University
Sponsor class: OTHER
Collaborators: name: University of Hawaii
name: Arizona State University
First posted: 2017-04-18
Enrollment: 486
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Dynamic wait-listed control group design
Primary purpose: PREVENTION

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.


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:

-

Primary outcomes:
measure: Number of participants using drug resistance strategies as measured by the Ho'ouna Pono Survey
timeFrame: 30 days
measure: Recent substance use
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hawaii Pacific University
name: Scott K Okamoto, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.