Lyme DiseaseNCT00594997
A School-Based Intervention to Reduce Lyme Disease
A study testing Education in people with Lyme Disease, run by Brigham and Women's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Lyme Disease
- What is being tested?
- Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,570 participants
- Where
- No sites listed yet
- Study dates
- Apr 2004to Aug 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child age 7-12 and their parents living in the selected endemic areas
Who cannot join
- No exclusions
About this study
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.
- Deliver an educational program in schools to promote personal protective practices, encourage early disease detection and modify residential habitats to reduce tick density.
- 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.
Read more
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:
- The educational intervention will reduce the incidence of Lyme disease among children and families living in an endemic area.
- The educational intervention will improve the childrens' self-confidence (behavioral self-efficacy), intention to perform, and actual practice of Lyme disease prevention behaviors.
Read the 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.
- Conditions
- Lyme Disease
- Being tested
- Education, Control (pre and post surveys)
- Keywords
- Lyme disease, educational intervention for children, tick borne illness, prophylactic therapy in children, Self-efficacy, tick prevention, tick avoidance, health behavior modification
- Medical subject headings
- Lyme Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
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)Behavioural
Students fill out a pre and post survey and then receive the same intervention given to the controls.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Education |
| Control | Active comparator | Students who fill out pre and post surveys and receive the intervention after the post-survey Receives: Behavioral: Control (pre and post surveys) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: baseline -1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startApr 2004
- Primary completionMar 2006
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Lyme DiseaseStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,570 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Nancy Shadick, Brigham and Women's Hospital
- Investigators
- Nancy A Shadick, MD, MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00594997
- Sponsor's protocol ID
- 2004P001033
- Status last verified
- Sep 2025
- First submitted
- 7 Jan 2008
- Last updated
- 3 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 17468463Corapi 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.
PubMed 17203005Phillips 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.
PubMed 11275450Shadick 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.
PubMed 11074914Shadick 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.
PubMed 9236962Shadick 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.
PubMed 27248436
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A School-Based Intervention to Reduce Lyme Disease
- ClinicalTrials.gov ID
- NCT00594997
- Acronym / sponsor ID
- 2004P001033
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,570 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Apr 2004
- Primary completion
- Mar 2006 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 16 Jan 2008 (estimated)
- Results
- Posted 6 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Deliver an educational program in schools to promote personal protective practices, encourage early disease detection and modify residential habitats to reduce tick density.
- 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:
- The educational intervention will reduce the incidence of Lyme disease among children and families living in an endemic area.
- The educational intervention will improve the childrens' self-confidence (behavioral self-efficacy), intention to perform, and actual practice of Lyme disease prevention behaviors.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education | Experimental | Behavioral: EducationStudents 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. |
| Control | Active comparator | Behavioral: Control (pre and post surveys)Students who fill out pre and post surveys and receive the intervention after the post-survey |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Child age 7-12 and their parents living in the selected endemic areas
Key exclusion criteria (1 listed)
- No exclusions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EducationStudents receive an educational intervention delivered by a member of our staff in conjunction with the teacher as well as a health education entertainer | Behavioural | Education |
| Control (pre and post surveys)Students fill out a pre and post survey and then receive the same intervention given to the controls. | Behavioural | Control |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17468463Daltroy 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.
- Background: PubMed 17203005Corapi 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.
- Background: PubMed 11275450Phillips 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.
- Background: PubMed 11074914Shadick 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.
- Background: PubMed 9236962Shadick 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.
- Derived from this study: PubMed 27248436Shadick 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy A Shadick, MD, MPH principal investigator
Brigham and Women's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Lyme Disease, run by Brigham and Women's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Incidence of Lyme Disease Among Children and Families Living in an Endemic Area Using an Educational Intervention (time frame: baseline - 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00594997, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.