Navigating Pregnancy and Parenthood With Lyme Disease

Parenting Clinical Trial

Official title:

Mixed Methods Study on Navigating Pregnancy and Parenthood With Lyme Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06397794
• Other study ID #: 00000932
• Status: Recruiting
• Start date: March 20, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: April 2024
• Source: Children's National Research Institute
• Contact: Meagan E Williams, MSPH, CCRC
• Phone: 202-476-3388
• Email: mewilliams[@]childrensnational.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lyme Disease
• Parenting
• Pregnancy Complications
• Tick-Borne Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	Children's National Hospital	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Children's National Research Institute	Clinical Trials Network for Lyme and Other Tick-Borne Diseases, Steven & Alexandra Cohen Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Understand the lived experiences of pregnancy and parenting among gestational parents with LD, PTLDS, and/or CL	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.	3/20/2024 - 3/1/2025
Secondary	Edinburgh Postnatal Depression Scale (EPDS)	Participants will complete the Edinburgh Postnatal Depression Scale (EPDS) prior to their qualitative interviews. The EPDS is a 10-question standardized postnatal depression screener.	3/20/2024 - 3/1/2025
Secondary	General Anxiety Disorder-7 (GAD-7)	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.	3/20/2024 - 3/1/2025
Secondary	Parenting Stress Index 4th Edition, Short Form (PSI-4 SF)	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.	3/20/2024 - 3/1/2025
Secondary	36-Item Short Form Survey (SF-36)	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.	3/20/2024 - 3/1/2025
Secondary	World Health Organization Disability Assessment Schedule (WHODAS 2.0)	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.	3/20/2024 - 3/1/2025
Secondary	Posttraumatic Diagnostic Scale (PDS-5)	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.	3/20/2024 - 3/1/2025
Secondary	Positive Affect and Well-Being Scale	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.	3/20/2024 - 3/1/2025

External Links

•   Participant enrollment screener