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

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Recruiting
CT.gov ID
NCT05247229
Collaborator
National Institute of Environmental Health Sciences (NIEHS) (NIH)
60
1
1
25.3
2.4

Study Details

Study Description

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, and a middle school after-school non-credit educational program coupled to a research program. Middle school students participating in the program will attend an after-school 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Middle school after-school education program
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Prevention of Paralytic Shellfish Poisoning in Subsistence Shellfish Harvest Communities of Southeast Alaska
Actual Study Start Date :
Mar 22, 2022
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Middle school after-school education program

The education intervention centers around teaching children about local traditional ecological knowledge and traditional harvesting and gathering practices, including those for shellfish. The education program is divided into three units, following other tribal education programs. Primary data collection will be conducted by unit to assess student learning for each unit. The first unit will cover an introduction to shellfish, harmful algal blooms (HAB), and paralytic shellfish poisoning (PSP). The second unit will cover herring and how herring relates to Tlingit culture. The third unit will focus on intertidal zones as zones relate to Tlingit culture.

Behavioral: Middle school after-school education program
The intervention assesses the impact of a middle school after-school education program on shellfish and toxin knowledge and clam harvesting planned behaviors. The intervention takes place weekly during the school year. The curriculum centers around teaching children about local traditional ecological knowledge and traditional harvesting and gathering practices.

Outcome Measures

Primary Outcome Measures

  1. Student assessment questionnaire of student learning from each educational unit. [Through study completion, pre and post educational unit (there are 3 educational units per academic semester, lasting approximately 4 weeks each).]

    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.

  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). [Through study completion, pre and post educational unit on shellfish (approximately 4 weeks).]

    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.

  3. Student assessment questionnaire of feelings about shellfish harvesting relevant to the Theory of Planned Behavior. [Through study completion, pre and post educational unit on shellfish (approximately 4 weeks).]

    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.

Secondary Outcome Measures

  1. 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. [Through study completion, pre and post academic semester-long educational program (the academic semester is approximately 12 weeks long).]

    The investigators will conduct interviews at the beginning and end of each semester's program (before and after all units).

  2. 5. Follow-up student assessment questionnaire of student learning to assess lasting behavioral changes from intervention participation. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Middle school student at Blatchley Middle School in Sitka, Alaska
Exclusion Criteria:
  • Not middle school student at Blatchley Middle School in Sitka, Alaska

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sitka Tribe of Alaska Sitka Alaska United States 99835

Sponsors and Collaborators

  • University of Alabama at Birmingham
  • National Institute of Environmental Health Sciences (NIEHS)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Matthew O'Madigan Gribble, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT05247229
Other Study ID Numbers:
  • 300006786
  • R01ES029165
First Posted:
Feb 18, 2022
Last Update Posted:
Apr 15, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 15, 2022