Cerebral PalsyNCT06380829
Psychometric Properties of the Self-Care Assessment Scale for 3-6 Year Old Children With Cerebral Palsy-Parent Form
An observational study of Cerebral Palsy and Self Care, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
This study is a methodological study to develop the self-care assessment scale-parent form of children with CP aged 3-6 years and test its validity and reliability. Q1. Is the Self-Care Assessment Scale for 3- to 6-year-old Children with CP a valid scale? Q2. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Cerebral Palsy, Self Care
- What is being tested?
- Questionnaire
- How many people
- 127 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jun 2023to 10 Feb 2024
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 3 to 6 years
- All sexes
- Child
Study population: Children with CP between the ages of 3-6
Who may be able to join
- Being between 3-6 years old (36-72 months) living with their parents
Who cannot join
- be at least literate He/she was able to speak and understand Turkish.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychometric Properties of the Self-Care Assessment Scale for 3-6 Year Old Children With Cerebral Palsy-Parent Form: Turkish Validity and Reliability Study
This study is a methodological study to develop the self-care assessment scale-parent form of children with CP aged 3-6 years and test its validity and reliability.
Q1. Is the Self-Care Assessment Scale for 3- to 6-year-old Children with CP a valid scale? Q2. Is the Self-Care Assessment Scale for 3- to 6-year-old Children with CP a reliable scale?
Read the detailed description
This methodological research was conducted with the parents of 127 children with cerebral palsy aged 3-6 years old who were receiving education in special education and rehabilitation centers. Data were collected using the Child-Parent Information Form and the Self-Care Assessment Scale for Children with CP aged 3-6 years Parent Form (SPÇÖRS-EF). Descriptive statistics, Kruskal-Wallis, Cronbach alpha, test-retest, Kaiser-Meyer-Olkin (KMO) test, Bartlett test, explanatory factor analysis and confirmatory factor analysis were used to analyze the data. The research was conducted with the parents of children aged 3-6 years old with cerebral palsy who came to nine special education and rehabilitation centers in four provinces in western Turkey to receive physical therapy between June 5 and December 5, 2023. The sample of the study was calculated by taking at least five times the total number of items in the scale (25 items*5=125, n=125). Non-probability random sampling method was used in sample selection. The research was completed with the participation of 127 parents. According to post hoc power analysis, this sample size was confirmed to be sufficient for 97% power (with a medium effect size d = 0.3 and α = 0.05 type I error). Criteria for inclusion in the study; The children were between the ages of 3-6 (36-72 months), lived with their parents, and the parents were at least literate and able to speak and understand Turkish. This study was conducted in accordance with the Helsinki Declaration and was approved by Aydın Adnan Menderes University Nursing Faculty Non-Interventional Ethics Committee (Date: 27.04.2023, Number: 2023/350). Verbal consent of the participants was obtained. Written permission was obtained from the special education and rehabilitation centers where the research was conducted.
- Conditions
- Cerebral Palsy, Self Care
- Being tested
- Questionnaire
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Self-Care Assessment Scale for Children with CP aged 3-6 years - Parent Form (SPÇÖS-EF): A draft scale named SPÇÖS-EF was prepared by the researchers, using the literature, to determine the self-care status of children with cerebral palsy aged 3-6.
What is being measured
The primary outcome is the main question the study is designed to answer.
To asses Turkish validity and reliability of Self-Care Assessment Scale for Children with CP aged 3-6 years
This study is a methodological study to develop the self-care assessment scale-parent form of children with CP aged 3-6 years and test its validity and reliability. The scale includes 24 items to question the child's self-care skills, such as independent nutrition, eating, being able to express himself while meeting his basic needs, toileting, dressing, washing hands and face, brushing teeth, cleaning his nose and expressing himself when he is sleepy, in accordance with his age. The scale is a 5-point Likert type, and each item is scored between 1-5, from "Always (independent)" to "Never (completely dependent)". In the scale, the 4th, 8th, 17th, 23rd scale items are reversed to obtain the total scale score. A minimum of 24 and a maximum of 120 points can be obtained from the scale. A high score from the scale indicates that the child with CP has good self-care skills.
Measured: six month from the beginning of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start5 Jun 2023
- Primary completion5 Dec 2023
- Study completion10 Feb 2024
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 PalsyStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 127 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bircan Kahraman Berberoglu, Aydin Adnan Menderes University
- Investigators
- BIRCAN KAHRAMAN BERBEROĞLU, PHD, Principal investigator, Aydın Adnan Menderes Univercity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06380829
- Sponsor's protocol ID
- Adnan Menderes
- Status last verified
- Apr 2024
- First submitted
- 19 Apr 2024
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kahraman Berberoglu B, Calisir H. The effect of structured supportive approach based on Kolcaba's comfort theory applied to parents of children with cerebral palsy on child's comfort, quality of life, and parent's self-efficacy: A randomised controlled trial. J Pediatr Nurs. 2024 Mar-Apr;75:e65-e74. doi: 10.1016/j.pedn.2023.12.032. Epub 2024 Jan 20.
PubMed 38246818
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychometric Properties of the Self-Care Assessment Scale for 3-6 Year Old Children With Cerebral Palsy-Parent Form: Turkish Validity and Reliability Study
- ClinicalTrials.gov ID
- NCT06380829
- Acronym / sponsor ID
- Adnan Menderes
- Conditions
- Cerebral Palsy, Self Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 5 Dec 2023 (actual)
- Study completion
- 10 Feb 2024 (actual)
- First posted
- 24 Apr 2024 (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.
This study is a methodological study to develop the self-care assessment scale-parent form of children with CP aged 3-6 years and test its validity and reliability.
Q1. Is the Self-Care Assessment Scale for 3- to 6-year-old Children with CP a valid scale? Q2. Is the Self-Care Assessment Scale for 3- to 6-year-old Children with CP a reliable scale?
Detailed description
This methodological research was conducted with the parents of 127 children with cerebral palsy aged 3-6 years old who were receiving education in special education and rehabilitation centers. Data were collected using the Child-Parent Information Form and the Self-Care Assessment Scale for Children with CP aged 3-6 years Parent Form (SPÇÖRS-EF). Descriptive statistics, Kruskal-Wallis, Cronbach alpha, test-retest, Kaiser-Meyer-Olkin (KMO) test, Bartlett test, explanatory factor analysis and confirmatory factor analysis were used to analyze the data. The research was conducted with the parents of children aged 3-6 years old with cerebral palsy who came to nine special education and rehabilitation centers in four provinces in western Turkey to receive physical therapy between June 5 and December 5, 2023. The sample of the study was calculated by taking at least five times the total number of items in the scale (25 items*5=125, n=125). Non-probability random sampling method was used in sample selection. The research was completed with the participation of 127 parents. According to post hoc power analysis, this sample size was confirmed to be sufficient for 97% power (with a medium effect size d = 0.3 and α = 0.05 type I error). Criteria for inclusion in the study; The children were between the ages of 3-6 (36-72 months), lived with their parents, and the parents were at least literate and able to speak and understand Turkish. This study was conducted in accordance with the Helsinki Declaration and was approved by Aydın Adnan Menderes University Nursing Faculty Non-Interventional Ethics Committee (Date: 27.04.2023, Number: 2023/350). Verbal consent of the participants was obtained. Written permission was obtained from the special education and rehabilitation centers where the research was conducted.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Age groups
- Child
- Study population
- Children with CP between the ages of 3-6
Key inclusion criteria (1 listed)
- Being between 3-6 years old (36-72 months) living with their parents
Key exclusion criteria (1 listed)
- be at least literate He/she was able to speak and understand Turkish.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireSelf-Care Assessment Scale for Children with CP aged 3-6 years - Parent Form (SPÇÖS-EF): A draft scale named SPÇÖS-EF was prepared by the researchers, using the literature, to determine the self-care status of children with cerebral palsy aged 3-6. | Other | – |
Primary outcome
To asses Turkish validity and reliability of Self-Care Assessment Scale for Children with CP aged 3-6 years
Time frame: six month from the beginning of the study
This study is a methodological study to develop the self-care assessment scale-parent form of children with CP aged 3-6 years and test its validity and reliability. The scale includes 24 items to question the child's self-care skills, such as independent nutrition, eating, being able to express himself while meeting his basic needs, toileting, dressing, washing hands and face, brushing teeth, cleaning his nose and expressing himself when he is sleepy, in accordance with his age. The scale is a 5-point Likert type, and each item is scored between 1-5, from "Always (independent)" to "Never (completely dependent)". In the scale, the 4th, 8th, 17th, 23rd scale items are reversed to obtain the total scale score. A minimum of 24 and a maximum of 120 points can be obtained from the scale. A high score from the scale indicates that the child with CP has good self-care skills.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Background: PubMed 38246818Kahraman Berberoglu B, Calisir H. The effect of structured supportive approach based on Kolcaba's comfort theory applied to parents of children with cerebral palsy on child's comfort, quality of life, and parent's self-efficacy: A randomised controlled trial. J Pediatr Nurs. 2024 Mar-Apr;75:e65-e74. doi: 10.1016/j.pedn.2023.12.032. Epub 2024 Jan 20.
- 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. This study is not recruiting at the moment.
BIRCAN KAHRAMAN BERBEROĞLU, PHD principal investigator
Aydın Adnan Menderes Univercity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Self Care, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To asses Turkish validity and reliability of Self-Care Assessment Scale for Children with CP aged 3-6 years (time frame: six month from the beginning of the study). 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 NCT06380829, 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 24 Apr 2024.