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Education Program for Paralytic Shellfish Poisoning
N/A
Recruiting
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up data collection one year following participation in the educational program.
Awards & highlights
Study Summary
This trial is testing whether an educational intervention can help prevent Paralytic Shellfish Poisoning (PSP) in children in Southeast Alaska. The intervention includes age-appropriate educational outreach in partnership with the Sitka School District, and a middle school after-school non-credit educational 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.
Who is the study for?
This trial is for middle school students at Blatchley Middle School in Sitka, Alaska. It aims to educate them on how to safely harvest shellfish and prevent Paralytic Shellfish Poisoning (PSP). Students not enrolled at this school are not eligible.Check my eligibility
What is being tested?
The trial tests an educational program designed to teach middle schoolers about the risks of PSP and safe clam harvesting practices. The goal is to see if the program changes their behavior towards shellfish consumption and reduces exposure to toxins.See study design
What are the potential side effects?
Since this intervention involves education rather than medication, there are no direct medical side effects. However, it's important that the information provided is accurate to effectively prevent poisoning.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ data collection one year following participation in the educational program.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~data collection one year following participation in the educational program.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Student assessment questionnaire of feelings about shellfish harvesting relevant to the Theory of Planned Behavior.
Student assessment questionnaire of student behaviors and behavioral intentions related to shellfish consumption and checking SEATOR website (accessing a tribal resource to prevent poisoning).
Student assessment questionnaire of student learning from each educational unit.
Secondary outcome measures
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.
5. Follow-up student assessment questionnaire of student learning to assess lasting behavioral changes from intervention participation.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Middle school education programExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,588 Previous Clinical Trials
2,280,252 Total Patients Enrolled
National Institute of Environmental Health Sciences (NIEHS)NIH
284 Previous Clinical Trials
1,232,677 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a middle school student at Blatchley Middle School in Sitka, Alaska.I am a middle school student at Hoonah City Schools.
Research Study Groups:
This trial has the following groups:- Group 1: Middle school education program
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment open to additional participants?
"Affirmative. According to clinicaltrials.gov, this experiment is actively seeking volunteers and was initially posted on March 22nd 2022 before being amended on April 14th 2022. They are recruiting 60 individuals from a single research site."
Answered by AI
To what degree is this research program populated by participants?
"Affirmative. Clinicaltrials.gov's data confirms that this study, which was initially advertised on March 22nd 2022, is currently recruiting volunteers. There are 60 spots still open at a single site for interested participants to join the trial."
Answered by AI
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