Clinical trial NCT05140122: LEONIDaS Caregivers Study
Official title: The LEONIDaS(Long Term Exploration of Outcomes From New Interventions in Dravet Syndrome) Caregivers Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Dravet Syndrome
Depression
Anxiety
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
First posted: 2021-12-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Caregivers of individuals with Dravet syndrome

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Willing and able to give informed consent for participation in the study
* Aged 18 years or above
* Primary caregiver of an individual with a medical history supporting a clinical diagnosis of Dravet syndrome
* Able to access the internet

Exclusion Criteria:

* Inability to provide informed written consent
* Another caregiver of the same individual with Dravet is already enrolled in the study

Primary outcomes:
measure: Anxiety and depression scores on the Hospital Anxiety and Depression Scale (HADS)
timeFrame: Follow up at three years
measure: Anxiety and depression scores on the Hospital Anxiety and Depression Scale (HADS)
timeFrame: Follow up at two years
measure: Anxiety and depression scores on the Hospital Anxiety and Depression Scale (HADS)
timeFrame: Follow up at one year
measure: Caregiver stress scores on the UW Caregiver Stress Scale
timeFrame: Follow up at three years
measure: Caregiver stress scores on the UW Caregiver Stress Scale
timeFrame: Follow up at two years
measure: Caregiver stress scores on the UW Caregiver Stress Scale
timeFrame: Follow up at one year
measure: Emotional processing biases on the Facial Expression Recognition Task (FERT)
timeFrame: Follow up at three years
measure: Emotional processing biases on the Facial Expression Recognition Task (FERT)
timeFrame: Follow up at two years
measure: Emotional processing biases on the Facial Expression Recognition Task (FERT)
timeFrame: Follow up at one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Oxford
name: Catherine Harmer, PhD
role: PRINCIPAL_INVESTIGATOR
References: