Cerebral Palsy InfantileNCT06912373
Experiences, Outcomes and Unmet Needs of Caregivers of Children With Cerebral Palsy
An observational study of Cerebral Palsy Infantile and Caregiver, run by Universitat de Lleida.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Palsy Infantile, Caregiver
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to 1 Aug 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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 .
Who may be able to join
- >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
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Experiences, Outcomes and Unmet Needs of Caregivers of Children With Cerebral Palsy in Spain: A Mixed-Method Study
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 ).
Read the 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
- Conditions
- Cerebral Palsy Infantile, Caregiver
- Keywords
- Caregivers, Cerebral Palsy, Mixed-Method Research, Quality of Life, Parenting Stress
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1
Secondary outcomes (2)
The Quality of Life
To assess the impact of pediatric chronic health conditions on caregivers and the family, the Spanish version of the PedsQL™ Family Impact Module will be used. This module employs a multidimensional parent self-report to evaluate physical, emotional, social, and cognitive functioning, as well as communication and worry. The module can be completed within 5-10 minutes
The PedsQL-FIM It is a 36-item with an internal consistency reliability of α = 0.97 (21). It assesses 8 main factors: physical functioning (6 items), emotional functioning (5 items), social functioning (4 items), cognitive functioning (4 items), communication (3 items), worry (5 items), daily activities (3 items) and family relationships (5 items). The answers are given on a 5-point Likert scale (0 = it is never a problem, 4 = it is almost always a problem) and are reversed scored and linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0). A greater score indicates better functioning.
Measured: Day 1
Burden
To asses caregiver burden, the Zarit Burden Interview will be used. The Zarit Burden Interview is a widely used self-report instrument for measuring caregiver burden. ZBI assesses caregivers´ perceptions of burden that may inadvertently affect their health, personal, social or financial wellbeing.
Caregivers are requested to assess the level of burden they experience while caring for a loved one. Burden is defined as the degree to which a caregiver perceives negative effects on their emotional and physical health, social life, and finances, which may hinder their ability to provide care. Responses vary from "not at all" to "extremely." It consists of 22 items, with the total score calculated by summing the scores of all the indicated items. It is suggested that a score from 0 to 21 means no to mild burden, 21 to 40 indicates mild to moderate burden, 41 to 60 indicates moderate to severe burden, and more than 61 means severe burden.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start1 Apr 2025 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy InfantileStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Universitat de Lleida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clàudia Arumí, Universitat de Lleida
- Investigators
- Francesc Valenzuela, PhD, Study director, Universitat de Lleida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06912373
- Sponsor's protocol ID
- ULleida3
- Status last verified
- Mar 2025
- First submitted
- 24 Mar 2025
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arumi-Trujillo C, Verdejo-Amengual FJ, Martinez-Navarro O, Vink JJT, Valenzuela-Pascual F. Experiences, outcomes and unmet needs of caregivers of children with Cerebral Palsy in Spain: Protocol for a mixed-methods study. PLoS One. 2026 Mar 13;21(3):e0342763. doi: 10.1371/journal.pone.0342763. eCollection 2026.
PubMed 41824430
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experiences, Outcomes and Unmet Needs of Caregivers of Children With Cerebral Palsy in Spain: A Mixed-Method Study
- ClinicalTrials.gov ID
- NCT06912373
- Acronym / sponsor ID
- ULleida3
- Conditions
- Cerebral Palsy Infantile, Caregiver
- Keywords
- Caregivers, Cerebral Palsy, Mixed-Method Research, Quality of Life, Parenting Stress
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universitat de LleidaUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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 .
Key inclusion criteria (5 listed)
- >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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Stress
Time frame: Day 1
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
2 secondary outcomes
The Quality of Life
Time frame: Day 1
Burden
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Derived from this study: PubMed 41824430Arumi-Trujillo C, Verdejo-Amengual FJ, Martinez-Navarro O, Vink JJT, Valenzuela-Pascual F. Experiences, outcomes and unmet needs of caregivers of children with Cerebral Palsy in Spain: Protocol for a mixed-methods study. PLoS One. 2026 Mar 13;21(3):e0342763. doi: 10.1371/journal.pone.0342763. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francesc Valenzuela, PhD study director
Universitat de Lleida
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy Infantile and Caregiver, run by Universitat de Lleida.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CLAUDIA ARUMI, Msc (+34630004767, claudia.arumi@udl.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06912373, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.