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Completed

NCT Number: NCT00594997

A School-Based Intervention to Reduce Lyme Disease

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.

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Key information

Conditions

Lyme Disease Bacterial Infections Bacterial Infections and Mycoses Borrelia Infections Gram-Negative Bacterial Infections Infections Spirochaetales Infections Tick-Borne Diseases Vector Borne Diseases

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The description of Lyme disease in 1976 and subsequent characterization of its mode of transmission, causative organism and treatment is one of the most remarkable advances in medicine in the last 25 years1-3. Nevertheless, Lyme disease continues to grow as a public health problem4. While Lyme disease affects all age groups, children have one of the highest rates4. Prevention remains a challenge in this group. The Lyme vaccine has been withdrawn from the market in February 20025, 6, and educational strategies among at-risk school children have been inadequately evaluated and none have been institutionalized.

We will target school-aged children living in Nantucket, Dukes County and Essex County. We have collaborated with the teachers and administration in many of the schools. We have collaborated with the teachers and administration in many of the schools.

The intervention will be delivered by a member of our staff in conjunction with the teacher as well as a health education entertainer ('Screaming with Pleasure Productions'). Research assistants will distribute the enrollment questionnaires and "goody" bags. The basic content of the educational message has been designed by Drs. Shadick, Liang, DeJong and the late Dr. Daltroy, and has been used extensively on the Nantucket ferry study and in the "Feel Find Free" Program. The timing takes advantage of the classroom audience, is humorous and entertaining and the message is relevant to anticipated outdoor activities.

Primary Outcome: The educational intervention will reduce the incidence of Lyme Disease among children and families living in an endemic area.

Secondary Outcomes: The educational intervention will improve the children's self-confidence (behavioral self-efficacy), intention to perform, and actual practice of Lyme disease prevention behaviors.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion:

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

Exclusion:

  • No exclusions

Treatment and study plan

Education

Behavioral

Students receive an educational intervention delivered by a member of our staff in conjunction with the teacher as well as a health education entertainer

Control (pre and post surveys)

Behavioral

Students fill out a pre and post survey and then receive the same intervention given to the controls.

Primary outcomes

  1. The Incidence of Lyme Disease Among Children and Families Living in an Endemic Area Using an Educational Intervention

    Time frame: baseline - 1 year

    Parents of children were asked at baseline to report any new case of Lyme Disease within the past 12 months. This question was asked again a year later after receiving the educational intervention was given. We then will compare the number of reported Lyme Disease cases at baseline to the number of Lyme disease cases reported a year later. New cases of Lyme Disease had to be confirmed by medical record review.

Secondary outcomes

  1. The Educational Intervention Will Improve the Children's Self-confidence (Behavioral Self-efficacy), Intention to Perform, and Actual Practice of Lyme Disease Prevention Behaviors.

    Time frame: baseline -1 year

    Three outcome measures, knowledge of LD transmission, self reported tick bite precautionary behaviors and attitudes towards taking precautions were measured. A Lyme Disease knowledge score was created from totaling the number of correct answers on the 6 knowledge questions, ranging from 0-6. A score with a higher value indicated an increase in the desired behavior. These questions were asked before and after the intervention to compared the change from preintervention with postintervention between intervention and control students, adjusted for age, sex and pre-knowledge score. Precautionary behavior outcomes were graded on a linear scale quantifying the amount of practice.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Important dates

Study start
2004
Primary completion
2006
Study completion
2016
First posted
Jan 16, 2008
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.

View the official ClinicalTrials.gov record (opens in a new tab)

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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