N/A
Completed N=50
Prevention of Paralytic Shellfish Poisoning in Subsistence Shellfish Harvest Communities of Southeast Alaska
Shellfish Poisoning, Paralytic
Source: ClinicalTrials.gov NCT05247229 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcomePrimary: Student Assessment Questionnaire of Student Learning From Each Educational Unit. — 4.2; 3.9 Scores on a scale — p=0.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Student Assessment Questionnaire of Student Learning From Each Educational Unit. |
4.2; 3.9 | 0.05 |
| PRIMARY Student Assessment Questionnaire of Student Behaviors and Behavioral Intentions Related to Shellfish Consumption and Checking SEATOR Website (Accessing a Tribal Resource to Prevent Poisoning). |
3.4; 2.8; 4.4; 3.9; 3.1 | 0.12 |
| PRIMARY Student Assessment Questionnaire of Feelings About Shellfish Harvesting Relevant to the Theory of Planned Behavior. |
4.2; 4.2; 4.4; 3.1; 4.4; 4.3 | 0.01 sig |
| SECONDARY Student Interviews to Qualitatively Assess Student Learning From All Educational Units and Changes in Student Perspectives, Behaviors, and Behavioral Intentions Related to Shellfish Harvesting. |
26; 20; 28 | — |
| SECONDARY Follow-up Student Assessment Questionnaire of Student Learning to Assess Lasting Behavioral Changes From Intervention Participation. |
5; 4.75; 5; 3.5 | — |
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
Data sourced from ClinicalTrials.gov (NCT05247229). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.