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/NCT05977114</url>
    </required_header>
    <id_info>
      <org_study_id>4Rs for a Better Family</org_study_id>
      <nct_id>NCT05977114</nct_id>
    </id_info>
    <brief_title>4Rs for a Better Family</brief_title>
    <official_title>4Rs for a Better Family (Review, Refresh, Restore, Rebuild) 家好之四重計劃: 重溫、重整、重塑、重建</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>City University of Hong Kong</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>City University of Hong Kong</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to learn about the effects of a family conflict&#xD;
        intervention in Chinese New Arrival families in Hong Kong.&#xD;
  &#xD;
        The main questions it aims to answer are:&#xD;
  &#xD;
          -  Is the family conflict intervention group more effective to improve parent-child&#xD;
             conflict resolution skills compared to the control group?&#xD;
  &#xD;
          -  Is the family conflict intervention group more effective to improve parental conflict&#xD;
             resolution skills compared to the control group?&#xD;
  &#xD;
          -  Is the family conflict intervention group more effective to enhance family resilience&#xD;
             compared to the control group?&#xD;
  &#xD;
        Participants will be randomly assigned to one of the two groups: the family conflict&#xD;
        intervention group and the handcraft-making group. For each group, parents will participate&#xD;
        in 3 sessions independently, children will participate in 2 sessions independently, and&#xD;
        parents and children will jointly participate in 1 session. Each session takes around 2&#xD;
        hours, and it takes 4 weeks to complete the full intervention. The family conflict&#xD;
        intervention sessions include an introduction to the occurrence of family conflicts,&#xD;
        communication skills training to prevent and address conflicts, and role play to practice the&#xD;
        skills, etc.&#xD;
  &#xD;
        Researchers will compare the family conflict intervention group and the handcraft-making&#xD;
        group to see if the family conflict intervention group is effective in promoting conflict&#xD;
        resolution skills, reducing family conflicts, and enhancing family resilience.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">June 2024</completion_date>
    <primary_completion_date type="Anticipated">April 2024</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>Prevention</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Parent-child conflicts (Yau &amp; Smetana, 1996)</measure>
      <time_frame>2 weeks</time_frame>
      <description>Parent-child conflicts are measured by the frequency and intensity of parent-child conflicts (Yau &amp; Smetana, 1996).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Parent-child conflict resolution style (Sun, 2019)</measure>
      <time_frame>2 weeks</time_frame>
      <description>Parent-child conflict resolution style will be measured by the Parent-child conflict resolution style scale (Sun, 2019).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The Chinese version of the Rahim Organizational Conflict Inventory-II (ROC-II; Rahim, 1983; Chang &amp; Lu, 2007)</measure>
      <time_frame>2 weeks</time_frame>
      <description>Couple conflict and problem-solving will be measured by the Chinese version of the Rahim Organizational Conflict Inventory-II (ROC-II; Rahim, 1983; Chang &amp; Lu, 2007).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Family Harmony Scale (Fabrizio et al., 2015)</measure>
      <time_frame>2 weeks</time_frame>
      <description>Family Harmony will be measured by the Family Harmony Scale (Fabrizio et al., 2015).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Family Resilience Quetionnaire (Walsh, 2015)</measure>
      <time_frame>2 weeks</time_frame>
      <description>Family Resilience will be measured by the Walsh Family Resilience Questionnaire (Walsh, 2015).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">400</enrollment>
    <condition>Family Relations</condition>
    <arm_group>
      <arm_group_label>4Rs Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>4As Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>family conflict intervention group</intervention_name>
      <description>The family conflict preventive intervention includes the introduction to the occurrence of family conflicts, communication skills training, and role play to practice the skills.</description>
      <arm_group_label>4Rs Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>handicraft-making group</intervention_name>
      <description>The group involves handicraft-making.</description>
      <arm_group_label>4As Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Parents who have newly arrived in Hong Kong for less than seven years, and their&#xD;
               children who are studying in primary school grade 4 to secondary school form 3; or&#xD;
  &#xD;
            2. New arrivals who have settled in Hong Kong for less than seven years and are studying&#xD;
               in primary school grade 4 to secondary school form 3, and their parents; and&#xD;
  &#xD;
            3. Parents and children must live together; and&#xD;
  &#xD;
            4. Parents and children must participate together&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Self-reported serious emotional or mental illness by parent or child, or&#xD;
  &#xD;
            2. Children with special learning needs&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Xiaonan Nancy YU, Doctoral</last_name>
      <role>Principal Investigator</role>
      <affiliation>City University of Hong Kong</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Xiaonan Nancy YU, Doctoral</last_name>
      <phone>34429436</phone>
      <email>nancy.yu@cityu.edu.hk</email>
    </overall_contact>
    <location>
      <facility>
        <name>International Social Service Hong Kong Branch</name>
        <address>
          <city>Hong Kong</city>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Iris Liu</last_name>
        <phone>2834 6863</phone>
        <email>isshk@isshk.org</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>City University of Hong Kong</investigator_affiliation>
      <investigator_full_name>Dr. Nancy Xiaonan Yu</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <!-- 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/NCT05977114
  org study id: 4Rs for a Better Family
  nct id: NCT05977114
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to learn about the effects of a family conflict
        intervention in Chinese New Arrival families in Hong Kong.
  
        The main questions it aims to answer are:
  
          -  Is the family conflict intervention group more effective to improve parent-child
             conflict resolution skills compared to the control group?
  
          -  Is the family conflict intervention group more effective to improve parental conflict
             resolution skills compared to the control group?
  
          -  Is the family conflict intervention group more effective to enhance family resilience
             compared to the control group?
  
        Participants will be randomly assigned to one of the two groups: the family conflict
        intervention group and the handcraft-making group. For each group, parents will participate
        in 3 sessions independently, children will participate in 2 sessions independently, and
        parents and children will jointly participate in 1 session. Each session takes around 2
        hours, and it takes 4 weeks to complete the full intervention. The family conflict
        intervention sessions include an introduction to the occurrence of family conflicts,
        communication skills training to prevent and address conflicts, and role play to practice the
        skills, etc.
  
        Researchers will compare the family conflict intervention group and the handcraft-making
        group to see if the family conflict intervention group is effective in promoting conflict
        resolution skills, reducing family conflicts, and enhancing family resilience.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Participant)
  measure: Parent-child conflicts (Yau & Smetana, 1996)
  time frame: 2 weeks
  description: Parent-child conflicts are measured by the frequency and intensity of parent-child conflicts (Yau & Smetana, 1996).
  measure: Parent-child conflict resolution style (Sun, 2019)
  time frame: 2 weeks
  description: Parent-child conflict resolution style will be measured by the Parent-child conflict resolution style scale (Sun, 2019).
  measure: The Chinese version of the Rahim Organizational Conflict Inventory-II (ROC-II; Rahim, 1983; Chang & Lu, 2007)
  time frame: 2 weeks
  description: Couple conflict and problem-solving will be measured by the Chinese version of the Rahim Organizational Conflict Inventory-II (ROC-II; Rahim, 1983; Chang & Lu, 2007).
  measure: Family Harmony Scale (Fabrizio et al., 2015)
  time frame: 2 weeks
  description: Family Harmony will be measured by the Family Harmony Scale (Fabrizio et al., 2015).
  measure: Family Resilience Quetionnaire (Walsh, 2015)
  time frame: 2 weeks
  description: Family Resilience will be measured by the Walsh Family Resilience Questionnaire (Walsh, 2015).
  arm group label: 4Rs Group
  arm group type: Experimental
  arm group label: 4As Group
  arm group type: Active Comparator
  intervention type: Behavioral
  intervention name: family conflict intervention group
  description: The family conflict preventive intervention includes the introduction to the occurrence of family conflicts, communication skills training, and role play to practice the skills.
  arm group label: 4Rs Group
  intervention type: Behavioral
  intervention name: handicraft-making group
  description: The group involves handicraft-making.
  arm group label: 4As Group
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Xiaonan Nancy YU, Doctoral
  role: Principal Investigator
  affiliation: City University of Hong Kong
  last name: Xiaonan Nancy YU, Doctoral
  phone: 34429436
  email: nancy.yu@cityu.edu.hk
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: City University of Hong Kong
  investigator full name: Dr. Nancy Xiaonan Yu
  investigator title: Associate Professor