LEONIDaS Caregivers Study

Status Withdrawn

Clinical Trial Summary

Dravet syndrome is a rare form of severe epilepsy that begins in the first year of life and is associated with frequent and/or prolonged seizures. Individuals with Dravet Syndrome often experience a range of comorbidities, including behavioral and developmental delays, movement and balance issues, sleep difficulties, chronic infections, and growth and nutritional issues. Patients with Dravet syndrome are at high risk of death due to SUDEP (Sudden Unexpected Death in Epilepsy), prolonged seizures, seizure-related accidents, and infections. Due to the severity of this condition, parents of children with Dravet syndrome are typically highly involved in their child's 24-hour care and this has a considerable impact on family life. Recent studies have highlighted the profound impact that such caregiving has on physical health, mental health, social function and financial resources. In particular, caregivers report high levels of stress and anxiety, fatigue, depression and social isolation. However, there is currently a lack of effective interventions to reduce the negative impact of caregiving on caregivers. The aim of this study is to prospectively study carers of individuals with Dravet syndrome to identify pharmacological and psychological factors that are associated with increased or decreased vulnerability to stress, depression and anxiety. Using a naturalistic, observational design the investigators will assess a cohort of Dravet Syndrome carers every six months for 3 years in order to further characterise trajectories of caregiver burden and the factors that influence this, including factors related to the person with Dravet syndrome (e.g. age, seizure frequency/severity, treatment/medications, comorbidities) and factors related to the carer and family environment (e.g. social engagement/isolation, fatigue, finances, relationships). The investigators will use both standardized questionnaires and a neurocognitive task (Facial Expression Recognition Task) to assess vulnerability to anxiety and depression. The study will be conducted online.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05140122
Study type	Observational
Source	University of Oxford
Contact
Status	Withdrawn
Phase
Start date	October 26, 2023
Completion date	October 26, 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

LEONIDaS Caregivers Study — LEONIDaS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms