Experiences, Outcomes and Unmet Needs of Caregivers of Children With Cerebral Palsy

Universitat de Lleida

Status: Not yet enrolling

Conditions: Cerebral Palsy Infantile; Caregiver

Study type: Observational

Funder types: Other

Identifiers

NCT06912373

ULleida3

Details and patient eligibility

About

Cerebral palsy (CP ) is one of the most prevalent motor disabilities in childhood, significantly impacting both children and their caregivers. This study explores the experiences, psychological well-being, and unmet needs of caregivers of children with CP. Using an explanatory sequential design (QUAN → QUAL), first it will be assessed burden, stress levels, and quality of life of caregivers through standardized questionnaires (PedsQL-FIM , ZBI , PSS-14 ).

Full description

Before the recruitment begins, the principal investigator will present the project to the pediatric service of the Arnau de Vilanova University Hospital of Lleida (HUAV). During medical consultations, the pediatric service will inform eligible participants about the study. If the caregiver agrees to participate, they will give consent for the pediatric service to share their contact details with the research team. The investigators will then contact the participant to explain the project in detail, schedule a first meeting to sign the Informed Consent, and complete the initial questionnaires. The Informed Consent will include the first author's contact information so that participants can address any questions or concerns about the study. Additionally, participants who sign the informed consent will be asked to provide their contact information for potential follow-up regarding the qualitative interview.

In the first meeting, participants who meet the inclusion criteria and have signed the informed consent will be directed to a study homepage hosted on the university's website. This website will provide a link to REDCap (Research Electronic Data Capture), a secure platform specifically designed for collecting research data (PedsQL-FIM, ZBI, PSS-14).

Participants' sociodemographic data will include descriptive information such as age, sex, household income, among others

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• >18 years old
• Being a caregiver of a child with Cerebral Palsy
• Spanish/Catalan speaking
• Willing to talk about their experiences and be audio/video-recorded.
• Accept and sign the informed consent form

Trial design

30 participants in 1 patient group

Cerebral Palsy caregivers

Description:

Quantitative data will be collected and analysed using three questionnaires, providing the authors with a comprehensive profile of participants' stress levels, quality of life, and caregiver burden. This data will also enable the identification of specific subgroups that will be the primary focus of the subsequent qualitative phase, while informing the development of new research questions for a deeper exploration during this phase. Participants who meet the inclusion criteria and have signed the informed consent will be directed to a study homepage hosted on the university's website. This website will provide a link to REDCap (Research Electronic Data Capture), a secure platform specifically designed for collecting research data (PedsQL-FIM, ZBI, PSS-14).