CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Middle school education programbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05247229
NCT05247229N/ACompleted

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

University of Alabama at Birmingham·interventional·Posted Feb 18, 2022·Updated Oct 3, 2025

In Brief

A clinical study evaluating Middle school education program for Shellfish Poisoning, Paralytic. Completed, enrolled 50 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2023202420252026
First PostedFeb 18, 2022
Enrollment StartMar 1, 2022
Primary CompletionJul 31, 2024
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 4.4 years ago

Interventions

Middle school education programbehavioral

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.