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Completed

NCT Number: NCT05247229

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hoonah City Schools, Hoonah, Alaska, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Middle school education program

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.

Primary outcomes

  1. Student Assessment Questionnaire of Student Learning From Each Educational Unit.

    Time frame: 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.

    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.

  2. Student Assessment Questionnaire of Student Behaviors and Behavioral Intentions Related to Shellfish Consumption and Checking SEATOR Website (Accessing a Tribal Resource to Prevent Poisoning).

    Time frame: 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.

    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.

  3. Student Assessment Questionnaire of Feelings About Shellfish Harvesting Relevant to the Theory of Planned Behavior.

    Time frame: 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.

    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.

Secondary outcomes

  1. Student Interviews to Qualitatively Assess Student Learning From All Educational Units and Changes in Student Perspectives, Behaviors, and Behavioral Intentions Related to Shellfish Harvesting.

    Time frame: Post education (following the semester-long program) at 10 weeks.

    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.

  2. Follow-up Student Assessment Questionnaire of Student Learning to Assess Lasting Behavioral Changes From Intervention Participation.

    Time frame: Data collection one year following participation in the educational program.

    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).

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Institute of Environmental Health Sciences (NIEHS)

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 18, 2022
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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