<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/NCT03800459</url>
  </required_header>
  <id_info>
    <org_study_id>2017-4242</org_study_id>
    <nct_id>NCT03800459</nct_id>
  </id_info>
  <brief_title>Effect of a Family Empowerment Program on Coping, Problem Solving in Parents, and Quality of Life in Children With Cystic Fibrosis</brief_title>
  <official_title>Effect of a Family Empowerment Program on Coping With Stress, Problem Solving in Parents, and Quality of Life in Children With Cystic Fibrosis: Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Selcuk University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Selcuk 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>
      Parents of children with cystic fibrosis (CF) experience high levels of stress and problems.&#xD;
      Family empowerment interventions provide important support for many patients with CF and&#xD;
      their families. However,there is a lack of research exploring the effects of such empowerment&#xD;
      programs on coping, and Problem Solving among parents, and Quality of Life in Children with&#xD;
      CF.&#xD;
&#xD;
      The present study aimed to assess the effect of a family empowerment program-based nursing&#xD;
      intervention on parents coping with stress and problem solving, and quality of life children&#xD;
      with CF.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Parents of children with cystic fibrosis (CF) experience high levels of stress and problems.&#xD;
      Family empowerment interventions provide important support for many patients with CF and&#xD;
      their families. However,there is a lack of research exploring the effects of such empowerment&#xD;
      programs on coping, and Problem Solving among parents, and Quality of Life in Children with&#xD;
      CF. The present study aimed to assess the effect of a family empowerment program-based&#xD;
      nursing intervention on parents coping with stress and problem solving, and quality of life&#xD;
      children with CF.&#xD;
&#xD;
      A single-blinded, parallel group pretest and posttest design randomized controlled trial was&#xD;
      used.&#xD;
&#xD;
      Data were collected over 5 months (January 2017-May 2017) from 48 participants in a medical&#xD;
      faculty hospital. They were randomly assigned to the experimental (n = 24) and control (n =&#xD;
      24) groups. Nursing interventions applied to the experimental group for ten weeks with the&#xD;
      intent of strengthening families consist of; providing individualized training and booklet&#xD;
      concerning disease management and providing phone calls and consultancy services for the&#xD;
      purpose of reinforcing the training and increasing the motivation. A routine polyclinic&#xD;
      follow-up was applied to the control group. Problem Solving Inventory (PSI), Scale of Ways of&#xD;
      Coping with Stress (SWCS), and The Cystic Fibrosis Questionnaire-Revised scale (CFQ-R) were&#xD;
      used reliable and valid instruments. The data were evaluated using the Wilcoxon Signed Ranks&#xD;
      test in evaluating dependent groups and the Mann-Whitney U test in independent groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 14, 2016</start_date>
  <completion_date type="Actual">June 2, 2017</completion_date>
  <primary_completion_date type="Actual">February 26, 2017</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Blindness in the study was done by data collectors and statisticians. The data were collected by the nurse who did not know who is in the experiment and control group.&#xD;
To reduce selection bias and to control the variables that may have an effect on outcome variables, random assignment was made to the experimental and the control group by a statistician who did not know the names and characteristics of the parents of and children with CF. The analysis of the data coded according to the groups was made by a statistician. After the statistical analyses were completed and the research report was written, the researcher explained the coding for the experimental and control group.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Child and parents information form</measure>
    <time_frame>3 weeks</time_frame>
    <description>The form was developed to define baseline characteristics and was based on previous literature. The questionnaire included questions regarding the sociodemographic characteristics of the participants, such as age, gender, educational level, income, duration of treatment and diagnosis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Problem Solving Inventory (PSI)</measure>
    <time_frame>10 weeks</time_frame>
    <description>Problem Solving Inventory (PSI) was measured using the 35-item Problem Solving Inventory Scale (Heppner &amp; Petersen, 1982). PSI; is a 35-item measure with a six-point Likert scale that assesses an individual's perceptions of his or her problem-solving styles, rather than actual problem-solving skills. Higher scores indicate an individual's assessment of oneself as a relatively ineffective problem solver. The PSI has a total score derived from three scales. The three subscales are: (a) Problem-Solving Confidence (PSC, 11 items); (b) ApproachAvoidance Style (AAS, 16 items); and (c) Personal Control (PC, 5 items). The PSC refers to an individual's belief and trust in one's own problem-solving ability. The AAS is defined as a general tendency to approach or avoid a wide range of problem-solving activities. The PC refers to individual's belief that one is in control of his or her own behaviors and emotions while solving problems.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scale of Ways of Coping with Stress (SWCS)</measure>
    <time_frame>10 weeks</time_frame>
    <description>The SWCS was developed by Folkman and Lazarus in 1980 (Folkman &amp; Lazarus 1980). The Turkish adaptation and validity study of SWCS was conducted by Şahin and Durak in 1995 (Şahin &amp; Durak 1995). The SWCS is a 4-point Likert-type scale ranging from 1 (Not appropriate) to 4 (Very appropriate). In the Turkish adaptation and validity study of the SWCS, factor analysis, comparisons of measurement-correlating validity and counter groups and validity for the SWCS were conducted and Cronbach's alpha reliability coefficients of the subscales were found between 0.45 and 0.80. The scale consisted of two groups; one was the effective coping ways (ECWs), which contained the optimistic approach, self-confident approach, and seeking social support, and the other group was the ineffective coping ways (ICWs), which included the hopelessness and submissive approaches.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Cystic Fibrosis Questionnaire-Revised (CFQ-R)</measure>
    <time_frame>10 weeks</time_frame>
    <description>The Cystic Fibrosis Questionnaire-Revised (CFQ-R) is a CF-specific health-related quality of life (HRQOL) questionnaire (Quiitner et al. in 2005). The CFQ-R is a 4-point Likert-type scale ranging from 1 to 4. Higher scores indicate better HRQOL</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Cystic Fibrosis</condition>
  <arm_group>
    <arm_group_label>Experimental: Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental: Intervention group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control:no intervation group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control:no intervation group</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>family empowerment program</intervention_name>
    <description>The empowerment program-nursing interventions were given in 6 sessions in the experimental group Session 1: Individualized training: General information about CF, respiratory system involvement and treatment process, airway cleaning in CF, drug applications (45-50 min) Session 2:Phone calls: Motivational and reminder interviews were carried out in order to reinforce the content of the first individual training (15 min).Session 3:Phone calls:Motivational and reminder interviews were carried out in order to reinforce the content of the first individual training (15 min) Session 4:Individualized training:protection from infections, nutrition and psychosocial support (45 min) Session 5:Phone calls: Motivational and reminder interviews were carried out in order to reinforce the content of the second individual training. (10 min) Session 6:Phone calls: Motivational and reminder interviews were carried out in order to reinforce the content of the second individual training. (10 min)</description>
    <arm_group_label>Experimental: Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children aged 6-18 years old;&#xD;
&#xD;
          -  Pulmonary functions Forced Expiratory Volume (FEV 1) over 40%&#xD;
&#xD;
          -  being able to communicate in Turkish,&#xD;
&#xD;
          -  voluntary parents in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  had mental disorders;&#xD;
&#xD;
          -  receiving mechanical ventilation;&#xD;
&#xD;
          -  Being in the process of lung transplantation;&#xD;
&#xD;
          -  having a sister/brother who died due to CF&#xD;
&#xD;
          -  Being in enteral or parenteral feeding;&#xD;
&#xD;
          -  having a chronic disease other than CF.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fatma Tas Arslan</last_name>
    <role>Study Director</role>
    <affiliation>Selcuk University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Selcuk University</name>
      <address>
        <city>Konya</city>
        <state>Eyalet/Yerleşke</state>
        <zip>42200</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 28, 2018</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>January 10, 2019</last_update_submitted>
  <last_update_submitted_qc>January 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Selcuk University</investigator_affiliation>
    <investigator_full_name>Fatma Taş Arslan</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Children with Cystic Fibrosis</keyword>
  <keyword>Parents</keyword>
  <keyword>Quality of Life</keyword>
  <keyword>Coping with Stress</keyword>
  <keyword>Problem Solving</keyword>
  <keyword>family empowerment program</keyword>
  <keyword>Nursing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystic Fibrosis</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03800459
org study id: 2017-4242
nct id: NCT03800459
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Parents of children with cystic fibrosis (CF) experience high levels of stress and problems.
      Family empowerment interventions provide important support for many patients with CF and
      their families. However,there is a lack of research exploring the effects of such empowerment
      programs on coping, and Problem Solving among parents, and Quality of Life in Children with
      CF.

      The present study aimed to assess the effect of a family empowerment program-based nursing
      intervention on parents coping with stress and problem solving, and quality of life children
      with CF.
Parents of children with cystic fibrosis (CF) experience high levels of stress and problems.
      Family empowerment interventions provide important support for many patients with CF and
      their families. However,there is a lack of research exploring the effects of such empowerment
      programs on coping, and Problem Solving among parents, and Quality of Life in Children with
      CF. The present study aimed to assess the effect of a family empowerment program-based
      nursing intervention on parents coping with stress and problem solving, and quality of life
      children with CF.

      A single-blinded, parallel group pretest and posttest design randomized controlled trial was
      used.

      Data were collected over 5 months (January 2017-May 2017) from 48 participants in a medical
      faculty hospital. They were randomly assigned to the experimental (n = 24) and control (n =
      24) groups. Nursing interventions applied to the experimental group for ten weeks with the
      intent of strengthening families consist of; providing individualized training and booklet
      concerning disease management and providing phone calls and consultancy services for the
      purpose of reinforcing the training and increasing the motivation. A routine polyclinic
      follow-up was applied to the control group. Problem Solving Inventory (PSI), Scale of Ways of
      Coping with Stress (SWCS), and The Cystic Fibrosis Questionnaire-Revised scale (CFQ-R) were
      used reliable and valid instruments. The data were evaluated using the Wilcoxon Signed Ranks
      test in evaluating dependent groups and the Mann-Whitney U test in independent groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
masking description: Blindness in the study was done by data collectors and statisticians. The data were collected by the nurse who did not know who is in the experiment and control group.
To reduce selection bias and to control the variables that may have an effect on outcome variables, random assignment was made to the experimental and the control group by a statistician who did not know the names and characteristics of the parents of and children with CF. The analysis of the data coded according to the groups was made by a statistician. After the statistical analyses were completed and the research report was written, the researcher explained the coding for the experimental and control group.
measure: Child and parents information form
time frame: 3 weeks
description: The form was developed to define baseline characteristics and was based on previous literature. The questionnaire included questions regarding the sociodemographic characteristics of the participants, such as age, gender, educational level, income, duration of treatment and diagnosis.
measure: Problem Solving Inventory (PSI)
time frame: 10 weeks
description: Problem Solving Inventory (PSI) was measured using the 35-item Problem Solving Inventory Scale (Heppner & Petersen, 1982). PSI; is a 35-item measure with a six-point Likert scale that assesses an individual's perceptions of his or her problem-solving styles, rather than actual problem-solving skills. Higher scores indicate an individual's assessment of oneself as a relatively ineffective problem solver. The PSI has a total score derived from three scales. The three subscales are: (a) Problem-Solving Confidence (PSC, 11 items); (b) ApproachAvoidance Style (AAS, 16 items); and (c) Personal Control (PC, 5 items). The PSC refers to an individual's belief and trust in one's own problem-solving ability. The AAS is defined as a general tendency to approach or avoid a wide range of problem-solving activities. The PC refers to individual's belief that one is in control of his or her own behaviors and emotions while solving problems.
measure: Scale of Ways of Coping with Stress (SWCS)
time frame: 10 weeks
description: The SWCS was developed by Folkman and Lazarus in 1980 (Folkman & Lazarus 1980). The Turkish adaptation and validity study of SWCS was conducted by Şahin and Durak in 1995 (Şahin & Durak 1995). The SWCS is a 4-point Likert-type scale ranging from 1 (Not appropriate) to 4 (Very appropriate). In the Turkish adaptation and validity study of the SWCS, factor analysis, comparisons of measurement-correlating validity and counter groups and validity for the SWCS were conducted and Cronbach's alpha reliability coefficients of the subscales were found between 0.45 and 0.80. The scale consisted of two groups; one was the effective coping ways (ECWs), which contained the optimistic approach, self-confident approach, and seeking social support, and the other group was the ineffective coping ways (ICWs), which included the hopelessness and submissive approaches.
measure: The Cystic Fibrosis Questionnaire-Revised (CFQ-R)
time frame: 10 weeks
description: The Cystic Fibrosis Questionnaire-Revised (CFQ-R) is a CF-specific health-related quality of life (HRQOL) questionnaire (Quiitner et al. in 2005). The CFQ-R is a 4-point Likert-type scale ranging from 1 to 4. Higher scores indicate better HRQOL
arm group label: Experimental: Intervention group
arm group type: Experimental
description: Experimental: Intervention group
arm group label: Control:no intervation group
arm group type: No Intervention
description: Control:no intervation group
intervention type: Behavioral
intervention name: family empowerment program
description: The empowerment program-nursing interventions were given in 6 sessions in the experimental group Session 1: Individualized training: General information about CF, respiratory system involvement and treatment process, airway cleaning in CF, drug applications (45-50 min) Session 2:Phone calls: Motivational and reminder interviews were carried out in order to reinforce the content of the first individual training (15 min).Session 3:Phone calls:Motivational and reminder interviews were carried out in order to reinforce the content of the first individual training (15 min) Session 4:Individualized training:protection from infections, nutrition and psychosocial support (45 min) Session 5:Phone calls: Motivational and reminder interviews were carried out in order to reinforce the content of the second individual training. (10 min) Session 6:Phone calls: Motivational and reminder interviews were carried out in order to reinforce the content of the second individual training. (10 min)
arm group label: Experimental: Intervention group
criteria: 
gender: All
minimum age: 6 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Fatma Tas Arslan
role: Study Director
affiliation: Selcuk University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Selcuk University
investigator full name: Fatma Taş Arslan
investigator title: Professor
mesh term: Cystic Fibrosis
mesh term: Fibrosis
sharing ipd: Undecided