Cerebral PalsyNCT04037137
Turkish Version of Caregiver Difficulties Scale: a Study of Reliability and Validity
An observational study of Cerebral Palsy and Caregiver Burnout, run by Sanko University at 1 site in Turkey (Türkiye).
Trial summary
As the life expectancy of individuals with Cerebral Palsy(CP) increases, their families' material, spiritual, physical and social difficulties increase, and in time, psychological and behavioral barriers occur in family members. Read more about this study
- Who is it for?
- Ages 24 to 70 years
- Conditions the study is for
- Cerebral Palsy, Caregiver Burnout
- What is being tested?
- Questionnaire
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2019to 26 Mar 2021
- 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 24 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Parents of individuals with CP patients
Who may be able to join
- Parents of individuals with CP receiving active treatment in a Special Education and Rehabilitation Center reported from Guidance and Research Centers after being diagnosed from all 2 nd and 3 rd health institutions in Gaziantep
- be willing to participate in the study
Who cannot join
- Having any diagnosed psychological disorder
Trial locations and contacts
1 site in 1 country.
About this study
As the life expectancy of individuals with Cerebral Palsy(CP) increases, their families' material, spiritual, physical and social difficulties increase, and in time, psychological and behavioral barriers occur in family members. While these barriers are increasing in developing countries, the whole family may be more vulnerable to the negative consequences of caring because of the limited availability of basic facilities for disabled people and the lack of temporary care services. The main aim of rehabilitation of individuals with CP is to improve their adaptive functions by increasing their postural control, locomotion and manipulative skills. Today, family-centered approaches for CP are known to be the most successful in terms of rehabilitation. Because the family is known to be of great importance in terms of active participation of the child in life. Therefore, while interdisciplinary treatments are in progress for the treatment of individuals, the success of rehabilitation is provided by interacting with the family, identifying their needs and problems and supporting them. There are many questionnaires developed to assess the difficulties experienced by the parents of individuals with CP. Of these, surveys adapted to Turkish are less common. The direct translation of the questionnaires into other languages does not guarantee its validity. If measures are to be used across cultures, it is known that the elements should not only be well translated linguistically, but also culturally adapted to maintain the content validity of the instrument across different cultures.
Read the detailed description
Cerebral Palsy(CP) is a lifelong disability and 65-90% of these individuals have a normal lifespan. A multidisciplinary team approach is needed to evaluate and treat individuals with CP. This team varies according to the age, developmental level, severity of functional independence and participation in the society. However, according to the needs and dependency levels of individuals as well as team members, the family is at the center of the lives of these teams and their children. Depending on the limitations of their physical abilities, individuals with CP may need help from others in daily living activities (toilet, bath, mobilization, eating), although their limitations vary according to their clinical types. Therefore, CP can affect the lives of all family members. Today, it is known that especially the parents of individuals with CP experience widespread anxiety, financial problems, time-related pressures, and social-cultural activities. While some families adapt well, others may have difficulty coping and making various adjustments. This results in parents' life satisfaction, poor quality and deterioration of personal well-being. As a result of a study examining the quality of life; the importance of evaluating caregivers with reduced quality of life, potentially having physical, psychological or social problems. One of the effective ways of coping with the disabilities of a child with CP is to consider primary caregivers, especially mothers. Therefore, assessment of caregivers' responsibilities and their impact on health is a fundamental requirement of long-term care programs for children with disabilities. Paying special attention to caregivers can be achieved by using specific tools that determine their needs and, together with all family members, not only improve the quality of life of the child, but also accelerate the treatment of the child (9). It is necessary to assess the responsibilities of care in order to provide access to the necessary facilities by providing good support to the caregivers. This can only be achieved by having an appropriate scale of caregiver responsibilities (9). The use of questionnaires to assess caregivers is most common in developed countries. When the literature is examined, the scale called 'Caregiver Difficulties Scale (CDS) en which evaluates the responsibilities of the caregivers of the individuals with CP and covers the responsibilities in every aspect (10). A Turkish validity and reliability study of several questionnaires evaluating children with CP was conducted in Turkey (11). However, there is only one scale for Turkish validity and reliability studies on parental involvement (11). The aim of this study is to determine whether the Caregiver Difficulties Scale (CDS) is a valid and reliable tool by cultural adaptation.
- Conditions
- Cerebral Palsy, Caregiver Burnout
- Being tested
- Questionnaire
- Keywords
- Caregiver Diffuculties Scale, reliability, validity, Turkish version
- Medical subject headings
- Cerebral Palsy, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Also called assesment
Caregiver Difficulties Scale, Impact on Family Scale, WHOQOL-BREF Quality of Life Assessment, Nottingham Health Profile, Fatigue Severity Scale, Beck Depression Scale
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Caregiver Diffuculties Scale (CDS)
CDS is a self-administered questionnaire designed to be completed by the principal caregiver of the child with Cerebral palsy.The 4 subscales of CDS and the corresponding items are as follows.Concerns for the child, Impact on self, Support for caregiving, Support for caregiving.There is no definite cut off threshold for CDS; the total CDS score can be used to get an idea about the level of burden experienced by the caregivers, a higher score indicating a higher level of burden.CDS shows that a high CDS score (above 42) is predictive of caregiver psychological problems. Therefore, CDS is also useful as a potential screening tool for identification of caregivers who are at risk of psychological problems such as stress, depression and anxiety.After the second application,the consistency and problems of the CDS questionnaire were reviewed.
Measured: first day and 2 weeks later
Impact on family scale
The original objective of the Impact on Family Scale is to assess the effect of a child's illness or health condition on the family. All items had astandard four-point scale ranging from strongly agree to strongly disagree.The four factors measured General Negative Impact (11 items), Disruption of Social Relations (nine items), Coping (four items), and Financial Impact (three items).Items are scored on a Likert scale.A low score indicates a higher impact of the chronic disease on the parents. Scores are calculated as percentages according to the highest scores of each part, using inverse proportion computing.
Measured: First day
Secondary outcomes (4)
Nottingham Health Profile
The NHP is an instrument designed to measure subjective health status containing 38items(answered "yes" or "no") that assess subjective distress in six subgroups:physical mobility (eight items), pain (eight items), sleep (five items), emotional reactions (nine items), social isolation (five items),and energy (three items). Scores for each subgroup range from 0 (no problem) to 100 (all problems listed were present).
Measured: first day
Fatigue Severity Scale
The FSS, which was published in 1989 by Krupp, has nine items. For each question, the patient is asked to choose a number from 1 to 7 that indicates how much the patient agrees with each statement, where 1 indicates strong disagreement and 7 indicates strong agreement. A score of 4 or higher generally indicates severe fatigue.
Measured: first day
Beck Depression Scale
This inventory comprises 21 questions, each with four possible answers (score: 0-3). If a symptom is more severe, the score will be higher. The higher the total score, the more depressed the patient.er the total score, the more depressed the patient. The Beck scores are divided in six grades of depression, according to the original description of the scores: 0-9: no or minimal depression 10-14: on the border of a depression 15-20: mild depression.21-30: mild-moderate depression. 31-40: moderate-severe depression. 41-63: severe depression.
Measured: first day
WHOQOL-BREF quality of life assessment
WHOQOL-BREF was scored over four domains: Physical Capacity (7 items), Psychological Well-being (6 items), Social Relationship (4 items), and Environment (9 items). All items were rated on a 5-point scale with a higher score indicating a higher quality of life.Domain scores were calculated by multiplying the mean of all facet scores included in each domain by a factor of 4, and accordingly, potential scores for each domain ranged from 4-20.Responses from the two items of the Overall Quality of Life and General Health facet were calculated as a single score with a range of 4-20, as with the scoring method for the four domain scores.
Measured: first day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start1 Aug 2019
- Primary completion26 Mar 2021
- Study completion26 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies 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
- Family based
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanko University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Adıgüzel, Sanko University
- Investigators
- Hatice Adıgüzel, PhD cd., Principal investigator, Sanko Universityİpek Katırcı Kirmaci, PhD cd., Principal investigator, Sanko UniversityNevin Ergun, Prof., Principal investigator, Sanko UniversitySuat Erel, Prof., Principal investigator, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04037137
- Sponsor's protocol ID
- Sanko M
- Status last verified
- Apr 2021
- First submitted
- 23 Jul 2019
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Version of Caregiver Difficulties Scale: a Study of Reliability and Validity
- ClinicalTrials.gov ID
- NCT04037137
- Acronym / sponsor ID
- Sanko M
- Conditions
- Cerebral Palsy, Caregiver Burnout
- Keywords
- Caregiver Diffuculties Scale, reliability, validity, Turkish version
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Sanko UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 26 Mar 2021 (actual)
- Study completion
- 26 Mar 2021 (actual)
- First posted
- 30 Jul 2019 (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.
As the life expectancy of individuals with Cerebral Palsy(CP) increases, their families' material, spiritual, physical and social difficulties increase, and in time, psychological and behavioral barriers occur in family members. While these barriers are increasing in developing countries, the whole family may be more vulnerable to the negative consequences of caring because of the limited availability of basic facilities for disabled people and the lack of temporary care services. The main aim of rehabilitation of individuals with CP is to improve their adaptive functions by increasing their postural control, locomotion and manipulative skills. Today, family-centered approaches for CP are known to be the most successful in terms of rehabilitation. Because the family is known to be of great importance in terms of active participation of the child in life. Therefore, while interdisciplinary treatments are in progress for the treatment of individuals, the success of rehabilitation is provided by interacting with the family, identifying their needs and problems and supporting them. There are many questionnaires developed to assess the difficulties experienced by the parents of individuals with CP. Of these, surveys adapted to Turkish are less common. The direct translation of the questionnaires into other languages does not guarantee its validity. If measures are to be used across cultures, it is known that the elements should not only be well translated linguistically, but also culturally adapted to maintain the content validity of the instrument across different cultures.
Detailed description
Cerebral Palsy(CP) is a lifelong disability and 65-90% of these individuals have a normal lifespan. A multidisciplinary team approach is needed to evaluate and treat individuals with CP. This team varies according to the age, developmental level, severity of functional independence and participation in the society. However, according to the needs and dependency levels of individuals as well as team members, the family is at the center of the lives of these teams and their children. Depending on the limitations of their physical abilities, individuals with CP may need help from others in daily living activities (toilet, bath, mobilization, eating), although their limitations vary according to their clinical types. Therefore, CP can affect the lives of all family members. Today, it is known that especially the parents of individuals with CP experience widespread anxiety, financial problems, time-related pressures, and social-cultural activities. While some families adapt well, others may have difficulty coping and making various adjustments. This results in parents' life satisfaction, poor quality and deterioration of personal well-being. As a result of a study examining the quality of life; the importance of evaluating caregivers with reduced quality of life, potentially having physical, psychological or social problems. One of the effective ways of coping with the disabilities of a child with CP is to consider primary caregivers, especially mothers. Therefore, assessment of caregivers' responsibilities and their impact on health is a fundamental requirement of long-term care programs for children with disabilities. Paying special attention to caregivers can be achieved by using specific tools that determine their needs and, together with all family members, not only improve the quality of life of the child, but also accelerate the treatment of the child (9). It is necessary to assess the responsibilities of care in order to provide access to the necessary facilities by providing good support to the caregivers. This can only be achieved by having an appropriate scale of caregiver responsibilities (9). The use of questionnaires to assess caregivers is most common in developed countries. When the literature is examined, the scale called 'Caregiver Difficulties Scale (CDS) en which evaluates the responsibilities of the caregivers of the individuals with CP and covers the responsibilities in every aspect (10). A Turkish validity and reliability study of several questionnaires evaluating children with CP was conducted in Turkey (11). However, there is only one scale for Turkish validity and reliability studies on parental involvement (11). The aim of this study is to determine whether the Caregiver Difficulties Scale (CDS) is a valid and reliable tool by cultural adaptation.
Study design
- Observational model
- Family based
- Time perspective
- Retrospective
Who may qualify
- Ages
- 24 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Parents of individuals with CP patients
Key inclusion criteria (2 listed)
- Parents of individuals with CP receiving active treatment in a Special Education and Rehabilitation Center reported from Guidance and Research Centers after being diagnosed from all 2 nd and 3 rd health institutions in Gaziantep
- be willing to participate in the study
Key exclusion criteria (1 listed)
- Having any diagnosed psychological disorder
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 |
|---|---|---|
| QuestionnaireAlso: assesmentCaregiver Difficulties Scale, Impact on Family Scale, WHOQOL-BREF Quality of Life Assessment, Nottingham Health Profile, Fatigue Severity Scale, Beck Depression Scale | Other | – |
Primary outcome
Change of Caregiver Diffuculties Scale (CDS)
Time frame: first day and 2 weeks later
CDS is a self-administered questionnaire designed to be completed by the principal caregiver of the child with Cerebral palsy.The 4 subscales of CDS and the corresponding items are as follows.Concerns for the child, Impact on self, Support for caregiving, Support for caregiving.There is no definite cut off threshold for CDS; the total CDS score can be used to get an idea about the level of burden experienced by the caregivers, a higher score indicating a higher level of burden.CDS shows that a high CDS score (above 42) is predictive of caregiver psychological problems. Therefore, CDS is also useful as a potential screening tool for identification of caregivers who are at risk of psychological problems such as stress, depression and anxiety.After the second application,the consistency and problems of the CDS questionnaire were reviewed.
Impact on family scale
Time frame: First day
The original objective of the Impact on Family Scale is to assess the effect of a child's illness or health condition on the family. All items had astandard four-point scale ranging from strongly agree to strongly disagree.The four factors measured General Negative Impact (11 items), Disruption of Social Relations (nine items), Coping (four items), and Financial Impact (three items).Items are scored on a Likert scale.A low score indicates a higher impact of the chronic disease on the parents. Scores are calculated as percentages according to the highest scores of each part, using inverse proportion computing.
4 secondary outcomes
Nottingham Health Profile
Time frame: first day
Fatigue Severity Scale
Time frame: first day
Beck Depression Scale
Time frame: first day
WHOQOL-BREF quality of life assessment
Time frame: first day
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 13 Apr 2021.
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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.
Hatice Adıgüzel, PhD cd. principal investigator
Sanko University
İpek Katırcı Kirmaci, PhD cd. principal investigator
Sanko University
Nevin Ergun, Prof. principal investigator
Sanko University
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 Caregiver Burnout, run by Sanko 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 2 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 13 Apr 2021. 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?
Change of Caregiver Diffuculties Scale (CDS) (time frame: first day and 2 weeks later). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2021.