Clinical trial NCT06912373: Experiences, Outcomes and Unmet Needs of Caregivers of Children With Cerebral Palsy
Official title: Experiences, Outcomes and Unmet Needs of Caregivers of Children With Cerebral Palsy in Spain: A Mixed-Method Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cerebral Palsy Infantile
Caregiver
Keywords: Caregivers
Cerebral Palsy
Mixed-Method Research
Quality of Life
Parenting Stress
Lead sponsor: Universitat de Lleida
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parents of children with developmental disorders or disabilities. The birth of a child with cerebral palsy can significantly alter the family's daily life, leading parents to feel denial, sadness, and guilt. They need to adapt to their child's limitations and find ways to handle these new challenges. In this sense, the birth of a child diagnosed with a chronic illness or disability, has the potential to change the family routine, triggering feelings of denial, sadness and guilt in the parental figures who need to learn to face the limitations of their children .

Brief summary: 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 ).

Detailed 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

Eligibility 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

Primary outcomes:
measure: Stress
timeFrame: Day 1
Secondary outcomes:
measure: The Quality of Life
timeFrame: Day 1
measure: Burden
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
affiliation: Universitat de Lleida
name: Francesc Valenzuela, PhD
role: STUDY_DIRECTOR
References: