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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).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Gülçin AŞUT, Doctorate contact

0546 841 96 48

g.asut@hotmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Igdir university

    Iğdır, 76000

    Gülçin AŞUT, Doctorate

    Recruiting

Other trials in Turkey (Türkiye)

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 groups in NCT06022172
Study groupRoleWhat they receive
Experimental groupExperimentalMOTIVATIONAL 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 GROUPNo interventionno action will be taken

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  2. 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.

  1. First posted1 Sep 2023
  2. Study start10 Sep 2023
  3. Primary completion10 Oct 2023 (estimated)
  4. Study completion30 Dec 2023 (estimated)

Resources

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)
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

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.

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