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

NCT ID: NCT05247229

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2024-07-31

Brief Summary

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.

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.

Conditions

Shellfish Poisoning, Paralytic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Middle school education program

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Environmental Health Sciences (NIEHS)

NIH

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Matthew O'Madigan Gribble

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hoonah City Schools

Hoonah, Alaska, United States

Dzantik'i Heeni Middle School

Juneau, Alaska, United States

Sitka Tribe of Alaska

Sitka, Alaska, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

R01ES029165

Identifier Type: NIH

Identifier Source: secondary_id

View Link

300006786

Identifier Type: -

Identifier Source: org_study_id