Interviews with Caregivers of autistic children and adolescents
Research type
Research Study
Full title
Interviews with Caregivers of autistic children and adolescents
IRAS ID
293037
Contact name
Lucile Bellier
Contact email
Sponsor organisation
Les laboratoires Servier
Duration of Study in the UK
0 years, 7 months, 31 days
Research summary
Research Summary
The objective of the project will be to conduct interviews to the caregivers of a sample of identified patients previously enrolled in the CL3-95008-001 and CL3-95008-002 clinical trials in order:
• To better understand the experience with the treatment of study (bumetanide) and the changes in ASD core symptoms: persistent impairment in reciprocal social communication and interaction and restricted and repetitive patterns of behaviour
• To identify unexpected treatment insights
• To assess the changes considered as meaningful by the patient and the caregiver
• To identify any potential unmet needs
• To support interpretation of the CL3-95008-001 and CL3-95008-002 primary endpoint (CARS2)
This is a non-interventional, descriptive, cross-sectional research study consisting of interviews with at least 15 caregivers will be conducted at two different timepoints.Summary of Results
Autism spectrum disorder (ASD) is characterised by difficulty with social communication and restricted, repetitive patterns of behaviour. This study aimed to improve understanding of the ASD patient experience with the treatment (bumetanide) regarding the changes in core symptoms and to assess changes considered as meaningful. To achieve this, qualitative interviews were conducted with caregivers of patients in 2 phase 3 clinical trials (NCT03715153; NCT03715166) of a novel ASD treatment.
Methods: Caregivers were invited to participate in 1 interview after completion of the pivotal phase 3 study; and for those of them who continued treatment after study completion, a second interview was held at 3 months after trial completion. The interviews were conducted by qualitative researchers and followed a semi-structured interview guide. The interviews focused on patients' ASD symptoms and their impact on their daily life prior to enrolment, and on any symptom changes patients experienced during the trial.
Results: Out of the 13 eligible patient’s caregivers, eleven were interviewed up to 2 times at clinical sites in the UK, Spain, and Italy. The caregivers reported impairments in a wide range of skills: deficits in communication and social interaction; restricted, repetitive patterns of behaviour, interests, or activities; cognitive, emotional, and motor impairments. Compared to the before the trial initiation, caregivers also reported improvements in the following domains: communication, interaction with others, cognition, aggression, emotions, repetitive movements, eating and sleeping.
Conclusion: The exit interviews provided a rich source of qualitative data, allowing a deeper understanding of caregivers’ and patients’ experience of the disease and allowing us to understand what constitutes a meaningful change. These data also helped to identify important experiences that may inform the patient.REC name
West of Scotland REC 4
REC reference
21/WS/0002
Date of REC Opinion
22 Feb 2021
REC opinion
Further Information Favourable Opinion