Navigating Pregnancy and Parenthood With Lyme Disease

• ClinicalTrials.gov Identifier: NCT06397794
• Recruitment Status: Recruiting
• First Posted: May 3, 2024
• Last Update Posted: May 3, 2024
• Sponsor: Children's National Research Institute
• Collaborators: Clinical Trials Network for Lyme and Other Tick-Borne Diseases; Steven & Alexandra Cohen Foundation
• Information provided by (Responsible Party): Children's National Research Institute

Study Description

Brief Summary:

This is a mixed methods study exploring the experiences of pregnancy and parenting among participants with Lyme disease. Eligible participants will have been diagnosed with Lyme disease (LD), post-treatment Lyme disease syndrome (PTLDS), and/or chronic Lyme (CL) either during or before a prior pregnancy. Participants will complete quantitative surveys on topics such as their medical history, their child(ren)'s development, and demographic information. They will then participate in a qualitative interview where they will be asked about their experiences with pregnancy and with parenting their child(ren) in the context of their condition.

Condition or disease	Intervention/treatment
Lyme Disease; Post Treatment Lyme Disease; Chronic Lyme Disease; Tick-Borne Infections; Tick-Borne Diseases; Pregnancy Complications; Parenting	Other: Quantitative surveys and qualitative interview

Detailed Description:

Patients with chronic conditions may experience the perinatal period and the experience of parenting differently than their healthy peers. The purpose of this study is to understand the lived experiences of pregnancy and parenting among gestational parents with Lyme disease.

Participants may be included in this study if they report having received a diagnosis of Lyme disease (LD), post-treatment Lyme disease syndrome (PTLDS), or chronic Lyme (CL) and they have given birth to at least one liveborn child. The investigators hypothesize that patients with LD/PTLDS/CL will experience unique challenges related to pregnancy, experiences in medical care settings, and their child's development.

Enrolled participants will complete a brief set of online quantitative questionnaires on topics such as their demographic characteristics, family information, Lyme disease histories, and mental health. The investigators will report on these data to illustrate similarities and differences between participants in the study for potentially relevant factors (e.g., timing of Lyme diagnosis relative to pregnancy, symptoms, mental health concerns). The questionnaires will be followed by an in-depth qualitative interview in English with each participant to learn about their experiences related to pregnancy and parenting with LD/PTLDS/CL, including specific questions about navigating the health care system, information seeking behaviors, and their child's development.

Study Design

• Study Type: Observational
• Estimated Enrollment: 30 participants
• Observational Model: Other
• Time Perspective: Other
• Official Title: Mixed Methods Study on Navigating Pregnancy and Parenthood With Lyme Disease
• Actual Study Start Date: March 20, 2024
• Estimated Primary Completion Date: March 1, 2025
• Estimated Study Completion Date: June 1, 2025

Groups and Cohorts

Group/Cohort

Intervention/treatment

Gestational parents with Lyme disease; Participants in this study will be enrolled following a screening call to assess their eligibility. All participants must report that they were diagnosed with acute Lyme disease, PTLDS, and/or Chronic Lyme by a health care provider while they were pregnant OR PTLDS/CL prior to becoming pregnant with ongoing symptoms during pregnancy. After being consented for the study, participants will then complete a set of online questionnaires and participate in a qualitative interview with a member of the research team.

Other: Quantitative surveys and qualitative interview; All participants will complete online surveys on topics including demographic and socioeconomic information, medical history (parent and child), pregnancy history, and mental health and well-being. They will then participate in a qualitative interview about their pregnancy and parenting experiences as gestational parents with Lyme disease.

Outcome Measures

Primary Outcome Measures :

1. Understand the lived experiences of pregnancy and parenting among gestational parents with LD, PTLDS, and/or CL [ Time Frame: 3/20/2024 - 3/1/2025 ]
   Semi-structured qualitative interviews will be conducted with parents with LD, PTLDS, and/or CL to understand their lived experience. The interviewer will follow a structured interview guide about participants' Lyme disease history, pregnancy, parenting experience, relationships, and their priorities. The interviewer will ask open-ended questions to understand participants' context and allow participants to share what they feel is important to them.

Secondary Outcome Measures :

1. Edinburgh Postnatal Depression Scale (EPDS) [ Time Frame: 3/20/2024 - 3/1/2025 ]
   Participants will complete the Edinburgh Postnatal Depression Scale (EPDS) prior to their qualitative interviews. The EPDS is a 10-question standardized postnatal depression screener.
2. General Anxiety Disorder-7 (GAD-7) [ Time Frame: 3/20/2024 - 3/1/2025 ]
   Participants will complete the General Anxiety Disorder-7 (GAD-7) screener prior to their qualitative interviews. The GAD-7 is a 7-question standardized assessment that measures severity of anxiety symptoms.
3. Parenting Stress Index 4th Edition, Short Form (PSI-4 SF) [ Time Frame: 3/20/2024 - 3/1/2025 ]
   Participants will complete the Parenting Stress Index 4th Edition, Short Form (PSI-4 SF) prior to their qualitative interviews. The PSI-4 SF is a standardized assessment that measures child and parent characteristics and stress experienced by a parent.
4. 36-Item Short Form Survey (SF-36) [ Time Frame: 3/20/2024 - 3/1/2025 ]
   Participants will complete the36-Item Short Form Survey (SF-36) prior to their qualitative interviews. The SF-36 is a standardized quality of life assessment.
5. World Health Organization Disability Assessment Schedule (WHODAS 2.0) [ Time Frame: 3/20/2024 - 3/1/2025 ]
   Participants will complete the WHO Disability Assessment Schedule (WHODAS 2.0) prior to their qualitative interviews. The WHODAS 2.0 is a 36-question standardized measure of health and disability.
6. Posttraumatic Diagnostic Scale (PDS-5) [ Time Frame: 3/20/2024 - 3/1/2025 ]
   Participants will complete a modified version of the Posttraumatic Diagnostic Scale (PDS-5) prior to their qualitative interviews. The PDS-5 is a 24-question standardized measure of posttraumatic stress symptomatology. Participants will answer questions specific to their experience with Lyme disease.
7. Positive Affect and Well-Being Scale [ Time Frame: 3/20/2024 - 3/1/2025 ]
   Participants will complete the Positive Affect and Well-Being Scale prior to their qualitative interviews. The Positive Affect and Well-Being Scale is a 9-item measure of participants' sense of well-being.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

We will enroll up to 30 participants in this study, all of whom have been pregnant in the past and given birth to at least one liveborn child. There is no limit to the number of children a participant has, age of child(ren), or duration of Lyme-related symptoms.

Criteria

Inclusion Criteria:

• Over 18 years of age and reside in the United States or Canada
• Diagnosed with acute Lyme disease, PTLDS, and/or Chronic Lyme by a health care provider while they were pregnant OR PTLDS/CL prior to becoming pregnant with ongoing symptoms during pregnancy

Exclusion Criteria:

• Under 18 years of age
• Live outside of the United States or Canada
• Never been diagnosed with Lyme disease by a medical provider
• Never been pregnant
• Never given birth to a liveborn infant
• Previously participated in a qualitative study about their experience with Lyme disease
• Do not want to agree to having their interviews audio recorded

Contacts and Locations

Contacts

Contact: Meagan E Williams, MSPH, CCRC; 202-476-3388; mewilliams@childrensnational.org

Contact: Sarah B. Mulkey, MD, PhD; sbmulkey@childrensnational.org

Locations

United States, District of Columbia

Children's National Hospital; Recruiting

Washington, District of Columbia, United States, 20010

Contact: Meagan Williams, MSPH, CCRC 202-476-3388 mewilliams@childrensnational.org

Principal Investigator: Sarah B. Mulkey, MD, PhD

Sub-Investigator: Roberta L. DeBiasi, MD, MS

Sponsors and Collaborators

Children's National Research Institute

Clinical Trials Network for Lyme and Other Tick-Borne Diseases

Steven & Alexandra Cohen Foundation

Investigators

• Principal Investigator: Sarah B. Mulkey, MD, PhD; Children's National Research Institute

More Information

Additional Information:

Participant enrollment screener 

• Responsible Party: Children's National Research Institute
• ClinicalTrials.gov Identifier: NCT06397794
• Other Study ID Numbers: 00000932
• First Posted: May 3, 2024
• Last Update Posted: May 3, 2024
• Last Verified: April 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Lyme Disease; Post-Lyme Disease Syndrome; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Tick-Borne Diseases; Urogenital Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Borrelia Infections; Spirochaetales Infections; Vector Borne Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes