NCT Number: NCT06397794
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.
Interested in participating?
Request Info18 year and older
Female
Observational
Washington D.C., District of Columbia, 20010, United States
Location status: Recruiting
Meagan Williams, MSPH, CCRC
CONTACT
Roberta L. DeBiasi, MD, MS
SUB_INVESTIGATOR
Sarah B. Mulkey, MD, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Meagan E Williams, MSPH, CCRC
CONTACT
Sarah B. Mulkey, MD, PhD
CONTACT
Children's National Research Institute
Other
Mixed Methods Study on Navigating Pregnancy and Parenthood With Lyme Disease
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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