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N/A N=3,570 Randomized Prevention

A School-Based Intervention to Reduce Lyme Disease

Lyme Disease

Enrolled (actual)
3,570
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: The Incidence of Lyme Disease Among Children and Families Living in an Endemic Area Using an Educational Intervention — 1; 1 Number of cases incident Lyme disease

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Education (Behavioral); Control (pre and post surveys) (Behavioral)
Age
Pediatric · 7+ yrs
Sex
All
Sponsor
Brigham and Women's Hospital
Primary completion
Mar 2006

Outcome Measures

OutcomeResultp-value
PRIMARY
The Incidence of Lyme Disease Among Children and Families Living in an Endemic Area Using an Educational Intervention
1; 1
SECONDARY
The Educational Intervention Will Improve the Children's Self-confidence (Behavioral Self-efficacy), Intention to Perform, and Actual Practice of Lyme Disease Prevention Behaviors.
1.38; 0.36 <0.0001 sig

Summary

Our overall purpose of this study is evaluate whether a short in-class Lyme Disease education program based on social learning theory and the Health Belief Model can impact a child's knowledge, attitude, and preventive behavior. 1. Deliver an educational program in schools to promote personal protective practices, encourage early disease detection and modify residential habitats to reduce tick density. 3. Evaluate the program's efficacy by comparing the acceptability and practice of precautionary behavior, tick density in residential areas and rates of Lyme disease between groups using primary and surveillance data sources Evaluate the contribution of knowledge, attitudes, and parental involvement to children's adoption of prevention strategies. Hypothesis The community intervention will reduce the incidence of Lyme disease among children and families living in endemic areas by increasing the practice of precautionary behavior and reducing tick density in residential areas. Specifically, we hypothesize that: 1. The educational intervention will reduce the incidence of Lyme disease among children and families living in an endemic area. 2. The educational intervention will improve the childrens' self-confidence (behavioral self-efficacy), intention to perform, and actual practice of Lyme disease prevention behaviors.

Eligibility Criteria

Inclusion:

  • Child age 7-12 and their parents living in the selected endemic areas

Exclusion:

  • No exclusions
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00594997). 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.

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