Prevention of Paralytic Shellfish Poisoning in Subsistence Shellfish Harvest Communities of Southeast Alaska

The purpose of this tribally co-led community-based participatory research in partnership with Sitka Tribe of Alaska was to help prevent Paralytic Shellfish Poisoning (PSP) in children of Southeast Alaska. The investigators assessed whether an education intervention led to changes in participants' planned behaviors related to clam harvesting that may reduce risks of exposure to shellfish toxins. This project included both a human subjects research component (this clinical trial) and a non-human environmental research component. In the non-human component, the tribe monitored for toxins in shellfish (including shellfish provided by people with data originally collected as a non-research service), and tested water for the presence of algae that make the toxin. The human subjects component involved age-appropriate K12 educational outreach in partnership with the Sitka School District, Hoonah City Schools, and Juneau School District, including a middle school after-school non-credit educational program coupled to a research program in Sitka, AK and Juneau, AK; and a middle school during school elective educational program coupled to a research program in Hoonah, AK. Middle school students participating in the program attended the program with several units designed to teach cultural practices, strengthen competencies toward Alaska science state standards, and evaluate shellfish consumption-related risk behaviors, while affirming traditional culture.

Study Overview

• Status: Completed
• Conditions: Shellfish Poisoning, Paralytic
• Intervention / Treatment: Behavioral: Middle school education program

Detailed Description

Subsistence use of natural resources, including the subsistence harvesting of shellfish, is central to Native cultures throughout Alaska. Shellfish harvesting appears as a motif in form line artwork and is a part of the traditional food ways taught by the tribes of Southeast Alaska to their youth. Saxitoxin, a toxin detected in Southeast Alaska that causes paralytic shellfish poisoning (PSP), was named after the butter clam (Saxidomus gigantea), which is a traditional food staple. The culturally central consumption of non-commercial shellfish puts Alaska Native communities at elevated risk for PSP. A population-based survey in two communities in coastal Alaska found that 20% of Alaska Natives in their sample reported a history of PSP.

The Theory of Planned Behavior is a behavioral science framework that has been applied in numerous public health settings to understand why people pursue specific actions. The Theory of Planned Behavior has been applied to children's health and to poisoning prevention/ environmental health, but as far as the investigators are aware this is the first pediatric poisoning prevention application of this framework. The project's K12 programming was developed with this framework in mind. For the middle school research program (this clinical trial), the investigators aimed to measure the relevant constructs for a theory-based investigation into children's poisoning-related risk behaviors in a context that affirms safe practice of cultural traditions.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alaska
    • Hoonah, Alaska, United States, 99829
      • Hoonah City Schools
    • Juneau, Alaska, United States, 99801
      • Dzantik'i Heeni Middle School
    • Sitka, Alaska, United States, 99835
      • Sitka Tribe of Alaska

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Middle school student at Blatchley Middle School in Sitka, Alaska or middle school student at Hoonah City Schools in Hoonah, Alaska or middle school student at Dzantik'i Heeni Middle School in Juneau, Alaska

Exclusion Criteria:

• Not middle school student at Blatchley Middle School in Sitka, Alaska or middle school student at Hoonah City Schools in Hoonah, Alaska or middle school student at Dzantik'i Heeni Middle School in Juneau, Alaska

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Middle school education program; The education intervention centered around teaching children about local traditional ecological knowledge and traditional harvesting and gathering practices, including those for shellfish. The education program was divided into three units, following other tribal education programs. Primary data collection was conducted by unit to assess student learning for each unit. The first unit covered an introduction to shellfish, harmful algal blooms (HAB), and paralytic shellfish poisoning (PSP). The second unit covered herring, and how herring relates to Tlingit culture. The third unit focused on intertidal zones as they relate to Tlingit culture.

Behavioral: Middle school education program; The intervention assessed the impact of a middle school education program (implemented as an after school program in Sitka, AK and Juneau, AK and during school hours as an elective in Hoonah, AK) on shellfish and toxin knowledge and clam harvesting planned behaviors. The intervention took place weekly during the school year. The curriculum centered around teaching children about local traditional ecological knowledge and traditional harvesting and gathering practices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Student Assessment Questionnaire of Student Learning From Each Educational Unit.	The investigators will assess student learning with pre-unit and post-unit written evaluations that collect information on students' cultural and scientific knowledge using Likert scale questions. Likert-scale responses ranged from disagree (1) to agree (5). Here we report post education unit outcomes. We report pre education unit outcomes in baseline characteristics. Questions 10 and 13 of our survey reflect this outcome measure.	The time frame is one educational semester, lasting 10 weeks (10 units administered weekly). Here we report post education unit outcomes (following the semester-long program). We report pre education program outcomes in baseline characteristics.
Student Assessment Questionnaire of Student Behaviors and Behavioral Intentions Related to Shellfish Consumption and Checking SEATOR Website (Accessing a Tribal Resource to Prevent Poisoning).	The investigators will assess changes in student self-reported behavioral history and student behavioral intentions with pre-unit and post-unit written evaluations that collect information on students' history to date of participating in subsistence shellfish harvest activities and students' behavioral intentions to participate in subsistence shellfish harvest activities and to check the SEATOR website, measured using Likert scale questions. Likert-scale responses ranged from disagree (1) to agree (5). Here we report post education unit outcomes. We report pre education unit outcomes in baseline characteristics. Questions 6, 7, 8, 15, and 16 reflect this outcome measure. Questions 8 and 16 are excluded from the pre-post program statistical tests as these questions are only relevant in the post-program survey.	The time frame is one educational semester, lasting 10 weeks (10 units administered weekly). Here we report post education unit outcomes (following the semester-long program). We report pre education program outcomes in baseline characteristics.
Student Assessment Questionnaire of Feelings About Shellfish Harvesting Relevant to the Theory of Planned Behavior.	The investigators will assess changes in student self-reported feelings about shellfish harvesting relevant to the Theory of Planned Behavior, including whether students think shellfish harvesting is enjoyable and rewarding, whether peers approve of shellfish harvesting and participate in shellfish harvesting, and whether students feel empowered to make shellfish harvesting decisions, with pre-unit and post-unit written evaluations that collect information on students' feelings about shellfish harvesting, measured using Likert scale questions. Likert-scale responses ranged from disagree (1) to agree (5). Here we report post education unit outcomes. We report pre education unit outcomes in baseline characteristics. Questions 1, 2, 3, 4, 5, 9, 10, 11, 12, 13, and 14 reflect this outcome measure. Questions 10 and 13 are used to assess both this outcome and primary outcome 1 and so are reported under both measures.	The time frame is one educational semester, lasting 10 weeks (10 units administered weekly). Here we report post education unit outcomes (following the semester-long program). We report pre education program outcomes in baseline characteristics.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Student Interviews to Qualitatively Assess Student Learning From All Educational Units and Changes in Student Perspectives, Behaviors, and Behavioral Intentions Related to Shellfish Harvesting.	The investigators conducted interviews at the beginning and end of each semester's program (before and after all units). To analyze data, a codebook was generated using both inductive and deductive approaches. First, codes were identified based on major themes in the interview protocol and relevant to the TPB. Next, all transcripts were reviewed to identify further themes not captured in deductively developed codes. This grounded theory approach was important to identify new themes raised by participants. Data was coded and analyzed using Dedoose software. Here we report themes raised in post-program interviews. Participant quotations reflecting these themes can be found in the published paper from this study.	Post education (following the semester-long program) at 10 weeks.
Follow-up Student Assessment Questionnaire of Student Learning to Assess Lasting Behavioral Changes From Intervention Participation.	The investigators will follow up with participants one year after participation in the educational program to assess whether participants have had any behavior changes related to subsistence shellfish consumption, measured using Likert scale questions. Likert-scale responses ranged from disagree (1) to agree (5).	Data collection one year following participation in the educational program.

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: National Institute of Environmental Health Sciences (NIEHS)

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): July 31, 2024
• Study Completion (Actual): July 31, 2024

Study Registration Dates

• First Submitted: January 31, 2022
• First Submitted That Met QC Criteria: February 9, 2022
• First Posted (Actual): February 18, 2022

Study Record Updates

• Last Update Posted (Estimated): October 3, 2025
• Last Update Submitted That Met QC Criteria: September 16, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Poisoning; Foodborne Diseases; Shellfish Poisoning
• Other Study ID Numbers: 300006786; R01ES029165 (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