Cerebral PalsyNCT06022172
Calgary Model Motivational Interviewing for Parents of Children With CP Care Burden Self-efficacy Coping With Stress
A study testing MOTIVATIONAL INTERVIEW BASED ON THE CALGARY FAMILY INTERVENTION MODEL IN PARENTS WITH A CHILD WITH CEREBRAL PALS. in people with Cerebral Palsy, run by Igdir University at 1 site in Turkey (Türkiye).
Trial summary
Cerebral palsy (CP) is a non-progressive problem that occurs as a result of damage or lesion in the brain tissue in the prenatal, perinatal or postnatal periods for any reason, causing permanent impairment in the development of posture and movement. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- MOTIVATIONAL INTERVIEW BASED ON THE CALGARY FAMILY INTERVENTION MODEL IN PARENTS WITH A CHILD WITH CEREBRAL PALS.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Sep 2023to 30 Dec 2023
- Phase
- Interventional
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Having a child with cerebral palsy between the ages of 6-18,
- Able to read and write Turkish, accessible and able to communicate,
- Orientation and cooperation
- Hearing, comprehension and vision problems,
- Parents who agreed to participate in the study were determined as .
Who cannot join
- Having difficulty in communication
- Not being literate
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Igdir university
Iğdır, 76000
Gülçin AŞUT, Doctorate
About this study
Official title: The Effect of Motivational Interviewing Based on the Calgary Family Intervention Model on Care Burden, Self-Efficacy and Coping With Stress in Parents of Children With Cerebral Palsy
Cerebral palsy (CP) is a non-progressive problem that occurs as a result of damage or lesion in the brain tissue in the prenatal, perinatal or postnatal periods for any reason, causing permanent impairment in the development of posture and movement. In addition to the impairments in the motor area in CP; It can be seen in problems such as perception, cognitive, sensory, communication, social, behavioral, musculoskeletal, epilepsy .Parents who are primary caregivers of the child with CP; They have a very important caregiver role in meeting the processes such as the treatment of the child, daily life needs and rehabilitation.Parental self-efficacy has been defined as the judgments and beliefs held by the parents to cope with the difficulties they experience in raising and caring for children with developmental disabilities and to reach the goal.The long process of caring for the child with cerebral palsy and the dependence of the child on the parent increase the stress of the caregivers. The Calgary Family Intervention Model (CAMM), one of the nursing models, is the first family intervention model in the field of nursing. The model focuses on improving, developing and maintaining the family's functionality in three areas. These three areas are cognitive, emotional and behavioral.
Read the detailed description
Cerebral palsy is a problem that causes permanent impairment in the development of non-progressive posture and movement, which occurs as a result of damage or lesion in the brain tissue for any reason in prenatal, perinatal or postnatal periods. In addition to the disorders in the motor area in SP; It can be seen in problems such as perception, cognitive, sensory, communication, social, behavioral, musculoskeletal, epilepsy .
Parents who are primary caregivers of the child with CP; They have a very important caregiver role in meeting the processes such as the treatment of the child, daily life needs and rehabilitation . Meeting all these special needs of the child with CP creates the burden of care for the parents .
Parental self-efficacy has been defined as the judgments and beliefs held by the parents to cope with the difficulties they experience in raising and caring for children with developmental disabilities and to reach the goal . People with high parental self-efficacy; It has been stated that they are more self-confident in taking and fulfilling their parenting duties, they make more effort, and they focus more on a solution in the face of any problem. The long process of caring for the child with cerebral palsy and the dependence of the child on the parent increase the stress of the caregivers. Caregiving stress affects the physiological, psychological, economic and social behaviors of parents.
The Calgary Family Intervention Model, one of the nursing models, is the first family intervention model in the field of nursing. The model focuses on improving, developing and maintaining the family's functionality in three areas. These three areas are cognitive, emotional and behavioral. The Calgary Family Intervention Model is an important model in increasing family functionality and providing change in pediatric nursing practice .
In the literature review, no other study has been found yet, examining the effect of motivational interviewing based on the Calgary Family Intervention model on the burden of care, self-efficacy and coping with stress in parents of children with cerebral palsy. It is believed that the motivational interview technique to be applied to the parents can be more beneficial for the children they care for and themselves, by revealing the effects of the disease, the responsibilities brought by the disease, the care burden arising from these responsibilities, parent self-efficacy and coping with stress.
Materials and Methods This study is a randomized controlled study. The research will be carried out in the interview rooms of the rehabilitation centers with the parents of children with cerebral palsy whose children attend a special rehabilitation center in the province of Iğdır.
The universe of the research will be the parents of 120 children with cerebral palsy between the ages of 6-18 who attend private rehabilitation centers in the province of Iğdır. Without using any sample selection method in the research, parents who meet the inclusion criteria and participate voluntarily in the research will be considered as the sample of the research. The number of samples was calculated in G*Power program. There is no similar research in the related literature. As a result of the power analysis performed before the study, the number of people to be included in the study group for percentage 80 power was calculated as 26. At least 30 parents will be included in both groups for possible sample loss during the implementation phase of the research. A list will be created by assigning a code number to each parent.
Personal information form, caregiving burden scale, Parental Self-Efficacy Scale, and Ways of Coping with Stress Scale developed by the researchers will be used to collect research data.
- Conditions
- Cerebral Palsy
- Being tested
- MOTIVATIONAL INTERVIEW BASED ON THE CALGARY FAMILY INTERVENTION MODEL IN PARENTS WITH A CHILD WITH CEREBRAL PALS.
- Keywords
- SP Ebeveyn Calgary Model Bakım Verme Öz-Yeterlik Stres
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOTIVATIONAL INTERVIEW BASED ON THE CALGARY FAMILY INTERVENTION MODEL IN PARENTS WITH A CHILD WITH CEREBRAL PALS.Diagnostic test
Motivational interview based on Calgary family intervention model in parents of children with cerebral palsy.
Introductory information form, caregiving burden, parent self-efficacy and stress coping styles scale will be used.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | MOTIVATIONAL INTERVIEW BASED ON THE CALGARY FAMILY INTERVENTION MODEL IN PARENTS WITH A CHILD WITH CEREBRAL PALS. Receives: Diagnostic Test: MOTIVATIONAL INTERVIEW BASED ON THE CALGARY FAMILY INTERVENTION MODEL IN PARENTS WITH A CHILD WITH CEREBRAL PALS. |
| CONTROL GROUP | No intervention | no action will be taken |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-test data collection
The research pre-test data will be carried out by the researcher between September 2023 and October 2023 in the interview rooms of rehabilitation centers, with the parents of children with cerebral palsy attending a private rehabilitation center in Iğdır. Introductory information form The burden of care for individuals in the experimental and control groups in data collection, parent self-efficacy scale and coping styles scale will be applied. In the care burden scale, a minimum score of 0 and a maximum of 88 points can be obtained from the scale. The lowest score in the self-efficacy scale is 17 and the highest score is 119. In the scale of coping with stress, the total score is calculated is not done.
Measured: Time frame 1 or 2 months.
Collection of post-test data
The motivational interview based on the Calgary family intervention model for each parent in the experimental group will consist of 6 sessions lasting 45 minutes, one week apart. After the interviews, the final test will be held after the last session and 15 days later. Parents of children with cerebral palsy whose children attend a special rehabilitation center in Istanbul will meet in the meeting rooms of the rehabilitation centers. Introductory information form, caregiver burden scale, parent self-efficacy scale and coping styles scale will be used to collect data.
A score of 88 can be obtained. The lowest score in the self-efficacy scale is 17, and the highest score is 119. The total score is not calculated in the scale of coping with stress.
Measured: Time frame one or two months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start10 Sep 2023
- Primary completion10 Oct 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 30 people in the experimental group and 30 people in the control group, a total of 60 people will be included in the study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Igdir University
- Sponsor type
- University, hospital or other
- Collaborators
- Kafkas University
- Responsible party
- Principal investigator, Gülçin Aşut, Igdir University
- Investigators
- Gülçin Aşut, Doctorate, Principal investigator, Igdir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06022172
- Sponsor's protocol ID
- Gulcin1
- Status last verified
- Sep 2023
- First submitted
- 14 Aug 2023
- Last updated
- 22 Sep 2023
- 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 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Motivational Interviewing Based on the Calgary Family Intervention Model on Care Burden, Self-Efficacy and Coping With Stress in Parents of Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06022172
- Acronym / sponsor ID
- Gulcin1
- Conditions
- Cerebral Palsy
- Keywords
- SP Ebeveyn Calgary Model Bakım Verme Öz-Yeterlik Stres
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Igdir UniversityUniversity, hospital or other
- Collaborators
- Kafkas University
- Study start
- 10 Sep 2023 (actual)
- Primary completion
- 10 Oct 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 1 Sep 2023 (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 a non-progressive problem that occurs as a result of damage or lesion in the brain tissue in the prenatal, perinatal or postnatal periods for any reason, causing permanent impairment in the development of posture and movement. In addition to the impairments in the motor area in CP; It can be seen in problems such as perception, cognitive, sensory, communication, social, behavioral, musculoskeletal, epilepsy .Parents who are primary caregivers of the child with CP; They have a very important caregiver role in meeting the processes such as the treatment of the child, daily life needs and rehabilitation.Parental self-efficacy has been defined as the judgments and beliefs held by the parents to cope with the difficulties they experience in raising and caring for children with developmental disabilities and to reach the goal.The long process of caring for the child with cerebral palsy and the dependence of the child on the parent increase the stress of the caregivers. The Calgary Family Intervention Model (CAMM), one of the nursing models, is the first family intervention model in the field of nursing. The model focuses on improving, developing and maintaining the family's functionality in three areas. These three areas are cognitive, emotional and behavioral.
Detailed description
Cerebral palsy is a problem that causes permanent impairment in the development of non-progressive posture and movement, which occurs as a result of damage or lesion in the brain tissue for any reason in prenatal, perinatal or postnatal periods. In addition to the disorders in the motor area in SP; It can be seen in problems such as perception, cognitive, sensory, communication, social, behavioral, musculoskeletal, epilepsy .
Parents who are primary caregivers of the child with CP; They have a very important caregiver role in meeting the processes such as the treatment of the child, daily life needs and rehabilitation . Meeting all these special needs of the child with CP creates the burden of care for the parents .
Parental self-efficacy has been defined as the judgments and beliefs held by the parents to cope with the difficulties they experience in raising and caring for children with developmental disabilities and to reach the goal . People with high parental self-efficacy; It has been stated that they are more self-confident in taking and fulfilling their parenting duties, they make more effort, and they focus more on a solution in the face of any problem. The long process of caring for the child with cerebral palsy and the dependence of the child on the parent increase the stress of the caregivers. Caregiving stress affects the physiological, psychological, economic and social behaviors of parents.
The Calgary Family Intervention Model, one of the nursing models, is the first family intervention model in the field of nursing. The model focuses on improving, developing and maintaining the family's functionality in three areas. These three areas are cognitive, emotional and behavioral. The Calgary Family Intervention Model is an important model in increasing family functionality and providing change in pediatric nursing practice .
In the literature review, no other study has been found yet, examining the effect of motivational interviewing based on the Calgary Family Intervention model on the burden of care, self-efficacy and coping with stress in parents of children with cerebral palsy. It is believed that the motivational interview technique to be applied to the parents can be more beneficial for the children they care for and themselves, by revealing the effects of the disease, the responsibilities brought by the disease, the care burden arising from these responsibilities, parent self-efficacy and coping with stress.
Materials and Methods This study is a randomized controlled study. The research will be carried out in the interview rooms of the rehabilitation centers with the parents of children with cerebral palsy whose children attend a special rehabilitation center in the province of Iğdır.
The universe of the research will be the parents of 120 children with cerebral palsy between the ages of 6-18 who attend private rehabilitation centers in the province of Iğdır. Without using any sample selection method in the research, parents who meet the inclusion criteria and participate voluntarily in the research will be considered as the sample of the research. The number of samples was calculated in G*Power program. There is no similar research in the related literature. As a result of the power analysis performed before the study, the number of people to be included in the study group for percentage 80 power was calculated as 26. At least 30 parents will be included in both groups for possible sample loss during the implementation phase of the research. A list will be created by assigning a code number to each parent.
Personal information form, caregiving burden scale, Parental Self-Efficacy Scale, and Ways of Coping with Stress Scale developed by the researchers will be used to collect research data.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 30 people in the experimental group and 30 people in the control group, a total of 60 people will be included in the study
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Diagnostic Test: MOTIVATIONAL INTERVIEW BASED ON THE CALGARY FAMILY INTERVENTION MODEL IN PARENTS WITH A CHILD WITH CEREBRAL PALS.MOTIVATIONAL INTERVIEW BASED ON THE CALGARY FAMILY INTERVENTION MODEL IN PARENTS WITH A CHILD WITH CEREBRAL PALS. |
| CONTROL GROUP | No intervention | –no action will be taken |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Having a child with cerebral palsy between the ages of 6-18,
- Able to read and write Turkish, accessible and able to communicate,
- Orientation and cooperation
- Hearing, comprehension and vision problems,
- Parents who agreed to participate in the study were determined as .
Key exclusion criteria (2 listed)
- Having difficulty in communication
- Not being literate
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 |
|---|---|---|
| MOTIVATIONAL INTERVIEW BASED ON THE CALGARY FAMILY INTERVENTION MODEL IN PARENTS WITH A CHILD WITH CEREBRAL PALS.Motivational interview based on Calgary family intervention model in parents of children with cerebral palsy. Introductory information form, caregiving burden, parent self-efficacy and stress coping styles scale will be used. | Diagnostic test | Experimental group |
Primary outcome
Pre-test data collection
Time frame: Time frame 1 or 2 months.
The research pre-test data will be carried out by the researcher between September 2023 and October 2023 in the interview rooms of rehabilitation centers, with the parents of children with cerebral palsy attending a private rehabilitation center in Iğdır. Introductory information form The burden of care for individuals in the experimental and control groups in data collection, parent self-efficacy scale and coping styles scale will be applied. In the care burden scale, a minimum score of 0 and a maximum of 88 points can be obtained from the scale. The lowest score in the self-efficacy scale is 17 and the highest score is 119. In the scale of coping with stress, the total score is calculated is not done.
Collection of post-test data
Time frame: Time frame one or two months.
The motivational interview based on the Calgary family intervention model for each parent in the experimental group will consist of 6 sessions lasting 45 minutes, one week apart. After the interviews, the final test will be held after the last session and 15 days later. Parents of children with cerebral palsy whose children attend a special rehabilitation center in Istanbul will meet in the meeting rooms of the rehabilitation centers. Introductory information form, caregiver burden scale, parent self-efficacy scale and coping styles scale will be used to collect data. A score of 88 can be obtained. The lowest score in the self-efficacy scale is 17, and the highest score is 119. The total score is not calculated in the scale of coping with stress.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
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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.
Gülçin Aşut, Doctorate principal investigator
Igdir University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MOTIVATIONAL INTERVIEW BASED ON THE CALGARY FAMILY INTERVENTION MODEL IN PARENTS WITH A CHILD WITH CEREBRAL PALS. in people with Cerebral Palsy, run by Igdir 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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 22 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gülçin AŞUT, Doctorate (0546 841 96 48, g.asut@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-test data collection (time frame: Time frame 1 or 2 months.). 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 22 Sep 2023.