Clinical trial NCT05247229: Prevention of Paralytic Shellfish Poisoning in Subsistence Shellfish Harvest Communities of Southeast Alaska
Official title: Prevention of Paralytic Shellfish Poisoning in Subsistence Shellfish Harvest Communities of Southeast Alaska
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shellfish Poisoning, Paralytic
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute of Environmental Health Sciences (NIEHS)
First posted: 2022-02-18
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this tribally co-led community-based participatory research in partnership with Sitka Tribe of Alaska is to help prevent Paralytic Shellfish Poisoning (PSP) in children of Southeast Alaska. The investigators assess whether an education intervention leads to changes in participants' planned behaviors related to clam harvesting that may reduce risks of exposure to shellfish toxins. This project includes both a human subjects research component (this clinical trial) and a non-human environmental research component. In the non-human component, the tribe is monitoring for toxins in shellfish (including shellfish provided by people with data originally collected as a non-research service), and testing water for the presence of algae that make the toxin. The human subjects component involves 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 will attend 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 has been developed with this framework in mind. For the middle school research program (this clinical trial), the investigators aim 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.

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

Primary outcomes:
measure: Student assessment questionnaire of student learning from each educational unit.
timeFrame: Through study completion, pre and post educational unit (there are 3 educational units per academic semester, lasting approximately 4 weeks each).
measure: Student assessment questionnaire of student behaviors and behavioral intentions related to shellfish consumption and checking SEATOR website (accessing a tribal resource to prevent poisoning).
timeFrame: Through study completion, pre and post educational unit on shellfish (approximately 4 weeks).
measure: Student assessment questionnaire of feelings about shellfish harvesting relevant to the Theory of Planned Behavior.
timeFrame: Through study completion, pre and post educational unit on shellfish (approximately 4 weeks).
Secondary outcomes:
measure: 4. Student interviews to qualitatively assess student learning from all educational units and changes in student perspectives, behaviors, and behavioral intentions related to shellfish harvesting.
timeFrame: Through study completion, pre and post academic semester-long educational program (the academic semester is approximately 12 weeks long).
measure: 5. Follow-up student assessment questionnaire of student learning to assess lasting behavioral changes from intervention participation.
timeFrame: Data collection one year following participation in the educational program.
Other outcomes:
Locations:
city: Hoonah
country: United States
facility: Hoonah City Schools
state: Alaska
city: Juneau
country: United States
facility: Dzantik'i Heeni Middle School
state: Alaska
city: Sitka
country: United States
facility: Sitka Tribe of Alaska
state: Alaska
Study officials:
References: