Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A School-Based Intervention to Reduce Lyme Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00594997
Recruitment Status : Completed
First Posted : January 16, 2008
Results First Posted : April 6, 2021
Last Update Posted : April 6, 2021
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Nancy Shadick, Brigham and Women's Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Lyme Disease Behavioral: Education Behavioral: Control (pre and post surveys) Not Applicable

Detailed Description:

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3570 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A School-Based Intervention to Reduce Lyme Disease
Study Start Date : April 2004
Actual Primary Completion Date : March 2006
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lyme Disease

Arm Intervention/treatment
Experimental: Education
Students who receive an educational intervention which consists of a 45 minute interactive presentation as well as a 30 minute health education entertainment by a juggler.
Behavioral: Education
Students receive an educational intervention delivered by a member of our staff in conjunction with the teacher as well as a health education entertainer

Active Comparator: Control
Students who fill out pre and post surveys and receive the intervention after the post-survey
Behavioral: Control (pre and post surveys)
Students fill out a pre and post survey and then receive the same intervention given to the controls.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion:

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

Exclusion:

  • No exclusions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00594997


Sponsors and Collaborators
Brigham and Women's Hospital
Centers for Disease Control and Prevention
Investigators
Layout table for investigator information
Principal Investigator: Nancy A Shadick, MD, MPH Brigham and Women's Hospital
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Nancy Shadick, Associate Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00594997    
Other Study ID Numbers: 2004P001033
First Posted: January 16, 2008    Key Record Dates
Results First Posted: April 6, 2021
Last Update Posted: April 6, 2021
Last Verified: March 2021
Keywords provided by Nancy Shadick, Brigham and Women's Hospital:
Lyme disease
educational intervention for children
tick borne illness
prophylactic therapy in children
Self-efficacy
tick prevention
tick avoidance
health behavior modification
Additional relevant MeSH terms:
Layout table for MeSH terms
Lyme Disease
Borrelia Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Tick-Borne Diseases
Spirochaetales Infections