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

NCT06912373 | Not Yet Recruiting DMC

• 1 other identifier: ULleida3
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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 ).

Conditions

Cerebral Palsy Infantile; Caregiver

Keywords

Caregivers; Cerebral Palsy; Mixed-Method Research; Quality of Life; Parenting Stress

Outcome Measures

Primary Outcomes (1)

• Stress

  The PSS-14 is short and easy adaptation of the original Perceived Stress Scale (PSS), with the original author being Cohen, S. The European Spanish adaptation was conducted by Remor, E. The PSS measures the degree to which individuals perceive life situations as stressful over the past month, focusing on subjective control over unpredictable events and the distress associated with perceived lack of control. The PSS is more closely related to subjective evaluations of life events than objective measures of stressors (18). The PSS-14 European Spanish version will be used and consists of 14 items scored from 0 up to 4 (0=never, 1 = rarely 2= sometimes 3= usually 4 =almost always). The total scores on the scale can range from 0 (no stress) to 56 (extreme stress). The European Spanish version PSS (14-item) demonstrated adequate reliability (internal consistency, alpha = .81, and test-retest, r = .73), validity (concurrent), and sensitivity

  Day 1

Secondary Outcomes (2)

• The Quality of Life

  Day 1

• Burden

  Day 1

Study Arms (1)

Cerebral Palsy caregivers

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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 .

You may qualify if:

• \>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

Sponsors & Collaborators

• Universitat de Lleida: lead

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Francesc Valenzuela, PhD

  Universitat de Lleida

  STUDY DIRECTOR

Central Study Contacts

CLAUDIA ARUMI, Msc

CONTACT

+34630004767; claudia.arumi@udl.cat

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clàudia Arumí-Trujillo

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: April 4, 2025
• Study Start: April 1, 2025
• Primary Completion: June 30, 2025
• Study Completion: August 1, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share