A School-Based Intervention to Reduce Lyme Disease

NCT00594997 | Completed Results

• 1 other identifier: 2004P001033
• Study Type: interventional
• Target: 3,570
• Locations: 0 countries
• Sites: N/A

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. 1.The educational intervention will reduce the incidence of Lyme disease among children and families living in an endemic area.
2. 2.The educational intervention will improve the childrens' self-confidence (behavioral self-efficacy), intention to perform, and actual practice of Lyme disease prevention behaviors.

Conditions

Lyme Disease

Keywords

Lyme disease; educational intervention for children; tick borne illness; prophylactic therapy in children; Self-efficacy; tick prevention; tick avoidance; health behavior modification

Outcome Measures

Primary Outcomes (1)

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

  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.

  baseline - 1 year

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.

  baseline -1 year

Study Arms (2)

Education

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

Students who fill out pre and post surveys and receive the intervention after the post-survey

Behavioral: Control (pre and post surveys)

Interventions

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

Education

Control (pre and post surveys) BEHAVIORAL

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

Control

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Centers for Disease Control and Prevention: collaborator

Related Publications (6)

• Daltroy LH, Phillips C, Lew R, Wright E, Shadick NA, Liang MH. A controlled trial of a novel primary prevention program for Lyme disease and other tick-borne illnesses. Health Educ Behav. 2007 Jun;34(3):531-42. doi: 10.1177/1090198106294646. Epub 2007 Apr 27.

  PMID: 17468463 BACKGROUND

• Corapi KM, White MI, Phillips CB, Daltroy LH, Shadick NA, Liang MH. Strategies for primary and secondary prevention of Lyme disease. Nat Clin Pract Rheumatol. 2007 Jan;3(1):20-5. doi: 10.1038/ncprheum0374.

  PMID: 17203005 BACKGROUND

• Phillips CB, Liang MH, Sangha O, Wright EA, Fossel AH, Lew RA, Fossel KK, Shadick NA. Lyme disease and preventive behaviors in residents of Nantucket Island, Massachusetts. Am J Prev Med. 2001 Apr;20(3):219-24. doi: 10.1016/s0749-3797(00)00315-9.

  PMID: 11275450 BACKGROUND

• Shadick NA, Lew RA, Liang MH. Outcomes of Lyme Disease. Ann Intern Med. 2000 Nov 7;133(9):746-747. doi: 10.7326/0003-4819-133-9-200011070-00023. No abstract available.

  PMID: 11074914 BACKGROUND

• Shadick NA, Daltroy LH, Phillips CB, Liang US, Liang MH. Determinants of tick-avoidance behaviors in an endemic area for Lyme disease. Am J Prev Med. 1997 Jul-Aug;13(4):265-70.

  PMID: 9236962 BACKGROUND

• Shadick NA, Zibit MJ, Nardone E, DeMaria A Jr, Iannaccone CK, Cui J. A School-Based Intervention to Increase Lyme Disease Preventive Measures Among Elementary School-Aged Children. Vector Borne Zoonotic Dis. 2016 Aug;16(8):507-15. doi: 10.1089/vbz.2016.1942. Epub 2016 Jun 1.

  PMID: 27248436 DERIVED

MeSH Terms

Conditions

Lyme Disease

Interventions

Educational Status; Lead

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Metals, Heavy; Elements; Inorganic Chemicals; Metals

Limitations and Caveats

Because all school districts were located in endemic areas for Lyme Disease, there was already a high level of awareness of Lyme Disease.

Results Point of Contact

• Title: Nancy Shadick
• Organization: Brigham and Women's Hospital

nshadick@partners.org

617-732-5266

Study Officials

• Nancy A Shadick, MD, MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 7, 2008
• First Posted: January 16, 2008
• Study Start: April 1, 2004
• Primary Completion: March 1, 2006
• Study Completion: August 1, 2016
• Last Updated: October 3, 2025
• Results First Posted: April 6, 2021

Record last verified: 2025-09