Shellfish Poisoning, ParalyticNCT05247229

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

A study testing Middle school education program in people with Shellfish Poisoning, Paralytic, run by University of Alabama at Birmingham at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Shellfish Poisoning, Paralytic
What is being tested?: Middle school education program
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 3 sitesUnited States
Study dates: 1 Mar 2022to 31 Jul 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Hoonah City Schools
Hoonah, Alaska, 99829
Dzantik'i Heeni Middle School
Juneau, Alaska, 99801
Sitka Tribe of Alaska
Sitka, Alaska, 99835

Other trials in United States

About this study

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.

Read the 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
Being tested: Middle school education program
Medical subject headings: Shellfish Poisoning

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Middle school education programBehavioural
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.

Study groups in NCT05247229
Study group	Role	What they receive
Middle school education program	Experimental	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. Receives: Behavioral: Middle school education program

What is being measured

The primary outcome is the main question the study is designed to answer.

Student Assessment Questionnaire of Student Learning From Each Educational Unit.
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.
Measured: 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.
Student Assessment Questionnaire of Student Behaviors and Behavioral Intentions Related to Shellfish Consumption and Checking SEATOR Website (Accessing a Tribal Resource to Prevent Poisoning).
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.
Measured: 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.
Student Assessment Questionnaire of Feelings About Shellfish Harvesting Relevant to the Theory of Planned Behavior.
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.
Measured: 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.

Secondary outcomes (2)

Student Interviews to Qualitatively Assess Student Learning From All Educational Units and Changes in Student Perspectives, Behaviors, and Behavioral Intentions Related to Shellfish Harvesting.
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.
Measured: Post education (following the semester-long program) at 10 weeks.
Follow-up Student Assessment Questionnaire of Student Learning to Assess Lasting Behavioral Changes From Intervention Participation.
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).
Measured: Data collection one year following participation in the educational program.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 202231 Jul 2024

First posted18 Feb 2022
Study start1 Mar 2022
Primary completion31 Jul 2024
Study completion31 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Shellfish Poisoning, ParalyticStudies of the same condition, open and under way.
More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05247229
Sponsor's protocol ID: 300006786
Other IDs: R01ES029165
Status last verified: Sep 2025
First submitted: 31 Jan 2022
Last updated: 3 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Roland HB, Kohlhoff J, Moore TR, Lanphier K, Pierce L, Narvaez J, Yazzie A, Whitehead C, Feldpausch J, Gribble MO. Influence of a Tribally Led Children's Environmental Education Program on Shellfish Harvesting Beliefs and Behavioral Intentions. Community Sci. 2025 Sep;4(3):e2025CSJ000128. doi: 10.1029/2025CSJ000128. Epub 2025 Sep 3.
PubMed 41574333

Study at a glance

From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prevention of Paralytic Shellfish Poisoning in Subsistence Shellfish Harvest Communities of Southeast Alaska
ClinicalTrials.gov ID: NCT05247229
Acronym / sponsor ID: 300006786
Conditions: Shellfish Poisoning, Paralytic
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: University of Alabama at BirminghamUniversity, hospital or other
Collaborators: National Institute of Environmental Health Sciences (NIEHS)
Study start: 1 Mar 2022 (actual)
Primary completion: 31 Jul 2024 (actual)
Study completion: 31 Jul 2024 (actual)
First posted: 18 Feb 2022 (actual)
Results: Posted 3 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Middle school education program	Experimental	Behavioral: Middle school education programThe 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.

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Middle school education programThe 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.	Behavioural	Middle school education program

Primary outcome

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.
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.
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.

2 secondary outcomes

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.
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.

Results and safety

Results posted to the registry on 3 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Middle School Education Program	50	50

Primary outcome: 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.. Mean (Standard Deviation). Unit: Scores on a scale

Measure	Middle School Education Program n = 50
10: Checking website before clamming is easy	4.2 (0.9)
13: I am confident I can check website before clam	3.9 (1.3)

Middle School Education Program: Slope: 0.37 (95% CI 0.00 to 0.73), p = 0.05, Chi-squared
Middle School Education Program: Slope: 0.22 (95% CI -0.25 to 0.70), p = 0.36, Chi-squared

Population analysed: Differences between the population numbers in the rows and the overall numbers are due to participant non-response.

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

Measure	Middle School Education Program n = 50
6: I intend to clam harvest this year	3.4 (1.4)
7: I have participated in clam harvesting	2.8 (1.8)
8: Learning clam safety I am more willing to clam	4.4 (0.9)
15: I intend to check website to decide to clam	3.9 (1.0)
16: I have used website to inform decision to clam	3.1 (1.5)

Middle School Education Program: Slope: -0.42 (95% CI -0.96 to 0.11), p = 0.12, Chi-squared
Middle School Education Program: Slope: 0.41 (95% CI -0.23 to 1.05), p = 0.21, Chi-squared
Middle School Education Program: Slope: 0.07 (95% CI -0.41 to 0.54), p = 0.78, Chi-squared

Population analysed: Differences between the population numbers in the rows and the overall numbers are due to participant non-response.

Primary outcome: Student Assessment Questionnaire of Feelings About Shellfish Harvesting Relevant to the Theory of Planned Behavior.

Measure	Middle School Education Program n = 50
1: Subsistence clam harvesting is enjoyable	4.2 (0.8)
2: Subsistence clam harvesting is rewarding	4.2 (1.0)
3: People I care about approve of clam harvest	4.4 (0.7)
4: Peers participate in clam harvesting	3.1 (1.2)
5: Whether I harvest is up to me	4.4 (0.7)
9: Checking website before clamming is rewarding	4.3 (0.8)
10: Checking website before clamming is easy	4.2 (0.9)
11: Those I get clams with approve of check site	4.3 (0.9)

Middle School Education Program: Slope: 0.51 (95% CI 0.16 to 0.86), p = 0.01, Chi-squared
Middle School Education Program: Slope: 0.09 (95% CI -0.34 to 0.52), p = 0.67, Chi-squared
Middle School Education Program: Slope: 0.13 (95% CI -0.15 to 0.41), p = 0.35, Chi-squared

Population analysed: Differences between the population numbers in the rows and the overall numbers are due to participant non-response.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were monitored from participant study enrollment through study completion, which was approximately 10 weeks (or one educational semester) following enrollment.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Middle School Education Program	0 of 50 (0%)	0 of 50 (0%)	0 of 50

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41574333Roland HB, Kohlhoff J, Moore TR, Lanphier K, Pierce L, Narvaez J, Yazzie A, Whitehead C, Feldpausch J, Gribble MO. Influence of a Tribally Led Children's Environmental Education Program on Shellfish Harvesting Beliefs and Behavioral Intentions. Community Sci. 2025 Sep;4(3):e2025CSJ000128. doi: 10.1029/2025CSJ000128. Epub 2025 Sep 3.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Middle school education program in people with Shellfish Poisoning, Paralytic, run by University of Alabama at Birmingham at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05247229, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.