xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06022172</url>
    </required_header>
    <id_info>
      <org_study_id>Gulcin1</org_study_id>
      <nct_id>NCT06022172</nct_id>
    </id_info>
    <brief_title>Calgary Model Motivational Interviewing for Parents of Children With CP Care Burden Self-efficacy Coping With Stress</brief_title>
    <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</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Igdir University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Kafkas University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Igdir University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Cerebral palsy (CP) is a non-progressive problem that occurs as a result of damage or lesion&#xD;
        in the brain tissue in the prenatal, perinatal or postnatal periods for any reason, causing&#xD;
        permanent impairment in the development of posture and movement. In addition to the&#xD;
        impairments in the motor area in CP; It can be seen in problems such as perception,&#xD;
        cognitive, sensory, communication, social, behavioral, musculoskeletal, epilepsy .Parents who&#xD;
        are primary caregivers of the child with CP; They have a very important caregiver role in&#xD;
        meeting the processes such as the treatment of the child, daily life needs and&#xD;
        rehabilitation.Parental self-efficacy has been defined as the judgments and beliefs held by&#xD;
        the parents to cope with the difficulties they experience in raising and caring for children&#xD;
        with developmental disabilities and to reach the goal.The long process of caring for the&#xD;
        child with cerebral palsy and the dependence of the child on the parent increase the stress&#xD;
        of the caregivers. The Calgary Family Intervention Model (CAMM), one of the nursing models,&#xD;
        is the first family intervention model in the field of nursing. The model focuses on&#xD;
        improving, developing and maintaining the family's functionality in three areas. These three&#xD;
        areas are cognitive, emotional and behavioral.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Cerebral palsy is a problem that causes permanent impairment in the development of&#xD;
        non-progressive posture and movement, which occurs as a result of damage or lesion in the&#xD;
        brain tissue for any reason in prenatal, perinatal or postnatal periods. In addition to the&#xD;
        disorders in the motor area in SP; It can be seen in problems such as perception, cognitive,&#xD;
        sensory, communication, social, behavioral, musculoskeletal, epilepsy .&#xD;
  &#xD;
        Parents who are primary caregivers of the child with CP; They have a very important caregiver&#xD;
        role in meeting the processes such as the treatment of the child, daily life needs and&#xD;
        rehabilitation . Meeting all these special needs of the child with CP creates the burden of&#xD;
        care for the parents .&#xD;
  &#xD;
        Parental self-efficacy has been defined as the judgments and beliefs held by the parents to&#xD;
        cope with the difficulties they experience in raising and caring for children with&#xD;
        developmental disabilities and to reach the goal . People with high parental self-efficacy;&#xD;
        It has been stated that they are more self-confident in taking and fulfilling their parenting&#xD;
        duties, they make more effort, and they focus more on a solution in the face of any problem.&#xD;
        The long process of caring for the child with cerebral palsy and the dependence of the child&#xD;
        on the parent increase the stress of the caregivers. Caregiving stress affects the&#xD;
        physiological, psychological, economic and social behaviors of parents.&#xD;
  &#xD;
        The Calgary Family Intervention Model, one of the nursing models, is the first family&#xD;
        intervention model in the field of nursing. The model focuses on improving, developing and&#xD;
        maintaining the family's functionality in three areas. These three areas are cognitive,&#xD;
        emotional and behavioral. The Calgary Family Intervention Model is an important model in&#xD;
        increasing family functionality and providing change in pediatric nursing practice .&#xD;
  &#xD;
        In the literature review, no other study has been found yet, examining the effect of&#xD;
        motivational interviewing based on the Calgary Family Intervention model on the burden of&#xD;
        care, self-efficacy and coping with stress in parents of children with cerebral palsy. It is&#xD;
        believed that the motivational interview technique to be applied to the parents can be more&#xD;
        beneficial for the children they care for and themselves, by revealing the effects of the&#xD;
        disease, the responsibilities brought by the disease, the care burden arising from these&#xD;
        responsibilities, parent self-efficacy and coping with stress.&#xD;
  &#xD;
        Materials and Methods This study is a randomized controlled study. The research will be&#xD;
        carried out in the interview rooms of the rehabilitation centers with the parents of children&#xD;
        with cerebral palsy whose children attend a special rehabilitation center in the province of&#xD;
        Iğdır.&#xD;
  &#xD;
        The universe of the research will be the parents of 120 children with cerebral palsy between&#xD;
        the ages of 6-18 who attend private rehabilitation centers in the province of Iğdır. Without&#xD;
        using any sample selection method in the research, parents who meet the inclusion criteria&#xD;
        and participate voluntarily in the research will be considered as the sample of the research.&#xD;
        The number of samples was calculated in G*Power program. There is no similar research in the&#xD;
        related literature. As a result of the power analysis performed before the study, the number&#xD;
        of people to be included in the study group for percentage 80 power was calculated as 26. At&#xD;
        least 30 parents will be included in both groups for possible sample loss during the&#xD;
        implementation phase of the research. A list will be created by assigning a code number to&#xD;
        each parent.&#xD;
  &#xD;
        Personal information form, caregiving burden scale, Parental Self-Efficacy Scale, and Ways of&#xD;
        Coping with Stress Scale developed by the researchers will be used to collect research data.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 10, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 10, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_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</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pre-test data collection</measure>
      <time_frame>Time frame 1 or 2 months.</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Collection of post-test data</measure>
      <time_frame>Time frame one or two months.</time_frame>
      <description>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.&#xD;
  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.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Cerebral Palsy</condition>
    <arm_group>
      <arm_group_label>Experimental group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>MOTIVATIONAL INTERVIEW BASED ON THE CALGARY FAMILY INTERVENTION MODEL IN PARENTS WITH A CHILD WITH CEREBRAL PALS.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>CONTROL GROUP</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>no action will be taken</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>MOTIVATIONAL INTERVIEW BASED ON THE CALGARY FAMILY INTERVENTION MODEL IN PARENTS WITH A CHILD WITH CEREBRAL PALS.</intervention_name>
      <description>Motivational interview based on Calgary family intervention model in parents of children with cerebral palsy.&#xD;
  Introductory information form, caregiving burden, parent self-efficacy and stress coping styles scale will be used.</description>
      <arm_group_label>Experimental group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Having a child with cerebral palsy between the ages of 6-18,&#xD;
  &#xD;
            -  Able to read and write Turkish, accessible and able to communicate,&#xD;
  &#xD;
            -  Orientation and cooperation&#xD;
  &#xD;
            -  Hearing, comprehension and vision problems,&#xD;
  &#xD;
            -  Parents who agreed to participate in the study were determined as .&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Having difficulty in communication&#xD;
  &#xD;
            -  Not being literate&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Gülçin Aşut, Doctorate</last_name>
      <role>Principal Investigator</role>
      <affiliation>Igdir University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Gülçin AŞUT, Doctorate</last_name>
      <phone>0546 841 96 48</phone>
      <email>g.asut@hotmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Igdir university</name>
        <address>
          <city>Iğdır</city>
          <zip>76000</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <contact>
        <last_name>Gülçin AŞUT, Doctorate</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Igdir University</investigator_affiliation>
      <investigator_full_name>Gülçin Aşut</investigator_full_name>
      <investigator_title>Teaching Assistant</investigator_title>
    </responsible_party>
    <keyword>SP Ebeveyn Calgary Model Bakım Verme Öz-Yeterlik Stres</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cerebral Palsy</mesh_term>
      <mesh_term>Caregiver Burden</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06022172
  org study id: Gulcin1
  nct id: NCT06022172
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention 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
  primary purpose: Supportive Care
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: Pre-test data collection
  time frame: Time frame 1 or 2 months.
  description: 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.
  measure: Collection of post-test data
  time frame: Time frame one or two months.
  description: 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.
  arm group label: Experimental group
  arm group type: Experimental
  description: MOTIVATIONAL INTERVIEW BASED ON THE CALGARY FAMILY INTERVENTION MODEL IN PARENTS WITH A CHILD WITH CEREBRAL PALS.
  arm group label: CONTROL GROUP
  arm group type: No Intervention
  description: no action will be taken
  intervention type: Diagnostic Test
  intervention name: MOTIVATIONAL INTERVIEW BASED ON THE CALGARY FAMILY INTERVENTION MODEL IN PARENTS WITH A CHILD WITH CEREBRAL PALS.
  description: 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.
  arm group label: Experimental group
  criteria: 
  gender: All
  minimum age: 6 Years
  maximum age: 18 Years
  healthy volunteers: No
  last name: Gülçin Aşut, Doctorate
  role: Principal Investigator
  affiliation: Igdir University
  last name: Gülçin AŞUT, Doctorate
  phone: 0546 841 96 48
  email: g.asut@hotmail.com
  facility: 
  contact: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Igdir University
  investigator full name: Gülçin Aşut
  investigator title: Teaching Assistant
  mesh term: Cerebral Palsy
  mesh term: Caregiver Burden