<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/NCT04463433</url>
  </required_header>
  <id_info>
    <org_study_id>bnulxy</org_study_id>
    <nct_id>NCT04463433</nct_id>
  </id_info>
  <brief_title>Psychological Intervention for Parent-child Relationship and Couple Relationship Under COVID-19 in China</brief_title>
  <official_title>Psychological Intervention for Parent-child Relationship and Couple Relationship Under COVID-19 in China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Normal University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Normal University</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>
      Under the COVID-19, individuals who were home Quarantine experienced new challenges on their&#xD;
      parent-child relationship and couple relationship. The current project aimed to provide&#xD;
      psychological interventions for both parents and couples in order to improving their&#xD;
      relationship. The online intervention of group intervention and individual intervention are&#xD;
      going to be conducted. The relationship between parent-child, couples and emotion regulation&#xD;
      will be tested.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 1, 2020</start_date>
  <completion_date type="Anticipated">January 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Parent-child conflict</measure>
    <time_frame>2 weeks</time_frame>
    <description>The efficacy of parent-child conflict resolution will be assessed by the conflict subscale of the Conflict in Parent-Child Relationships. Scoring is based on a 5-point Likert scale with higher total scores indicate high level of conflict in the parent - child relationship.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parent-child communication</measure>
    <time_frame>2 weeks</time_frame>
    <description>The efficacy of communication, will be assessed by the family communication scale. Scoring is based on a 5-point Likert scale with regard to the quality of parent-child interactions. Higher total scores on individual and combined subscales indicate more positive parent-child interactions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parent-child Relationship</measure>
    <time_frame>2 weeks</time_frame>
    <description>The efficacy of parent-child relationship intervention will be assessed by the parent-child relationship scale. Higher total scores indicate higher quality of parent-child relationship.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Couple Relationship Quality</measure>
    <time_frame>2 weeks</time_frame>
    <description>The efficacy of Couple Relationship Intervention will be assessed by the quality of marriage index. Higher total scores indicate higher quality of couple relationship.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Marital Stability</measure>
    <time_frame>2 weeks</time_frame>
    <description>The efficacy of Couple Relationship Intervention will be assessed by the stability of marriage scale-short form. Higher total scores indicate higher stability of couple relationship.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Parent-child Relationship and Couple Relationship Under COVID-19 in China</condition>
  <arm_group>
    <arm_group_label>Parent-child Relationship Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention involves five 2h weekly group sessions in which exercises in mindfulness are practiced and associated ABCDE theory is taught to improve emotional regulation and parent-child communication under COVID-2019.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Couple Relationship Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention involves four 2h weekly group sessions in which express feelings and wants clearly are practiced and associated Satir communication model is taught to improve couple conflict resolution and communication under COVID-2019.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive and behavioral intervention.</intervention_name>
    <description>Two hours group sessions including mindfulness and emotion regulation. The practice of mindfulness is taught to parents to become aware of their thoughts and emotion on the present moment. The behavioral intervention has parents develop an Positive Time-out for dealing with conflict and negativity, using strategies to down-regulate their own negative emotions.</description>
    <arm_group_label>Parent-child Relationship Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Problem-solving and relationship improvement intervention.</intervention_name>
    <description>Two hours group sessions including problem-solving and improving marital relationship . In the problem-solving part, the knowledge and techniques of problem-solving are taught to couple. relationship improvement part which promote the couple relationship by being aware of their own and their partner's deep-seated needs and communicating in a congruent way.</description>
    <arm_group_label>Couple Relationship Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Parents of students in primary and secondary school.&#xD;
&#xD;
          2. Parents must had primary school education or above.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Parents cannot speak or read Chinese.&#xD;
&#xD;
          2. Parents have severe mental or physical illness.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Beijing Normal University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100875</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiuyun Lin, professor</last_name>
      <phone>8610-58805770</phone>
      <email>linxy@bnu.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>April 12, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>July 8, 2020</last_update_submitted>
  <last_update_submitted_qc>July 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Normal University</investigator_affiliation>
    <investigator_full_name>Xiuyun Lin</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>Parent-child Relationship</keyword>
  <keyword>Couple Relationship</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04463433
org study id: bnulxy
nct id: NCT04463433
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Under the COVID-19, individuals who were home Quarantine experienced new challenges on their
      parent-child relationship and couple relationship. The current project aimed to provide
      psychological interventions for both parents and couples in order to improving their
      relationship. The online intervention of group intervention and individual intervention are
      going to be conducted. The relationship between parent-child, couples and emotion regulation
      will be tested.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
measure: Parent-child conflict
time frame: 2 weeks
description: The efficacy of parent-child conflict resolution will be assessed by the conflict subscale of the Conflict in Parent-Child Relationships. Scoring is based on a 5-point Likert scale with higher total scores indicate high level of conflict in the parent - child relationship.
measure: Parent-child communication
time frame: 2 weeks
description: The efficacy of communication, will be assessed by the family communication scale. Scoring is based on a 5-point Likert scale with regard to the quality of parent-child interactions. Higher total scores on individual and combined subscales indicate more positive parent-child interactions.
measure: Parent-child Relationship
time frame: 2 weeks
description: The efficacy of parent-child relationship intervention will be assessed by the parent-child relationship scale. Higher total scores indicate higher quality of parent-child relationship.
measure: Couple Relationship Quality
time frame: 2 weeks
description: The efficacy of Couple Relationship Intervention will be assessed by the quality of marriage index. Higher total scores indicate higher quality of couple relationship.
measure: Marital Stability
time frame: 2 weeks
description: The efficacy of Couple Relationship Intervention will be assessed by the stability of marriage scale-short form. Higher total scores indicate higher stability of couple relationship.
arm group label: Parent-child Relationship Intervention
arm group type: Experimental
description: The intervention involves five 2h weekly group sessions in which exercises in mindfulness are practiced and associated ABCDE theory is taught to improve emotional regulation and parent-child communication under COVID-2019.
arm group label: Couple Relationship Intervention
arm group type: Experimental
description: The intervention involves four 2h weekly group sessions in which express feelings and wants clearly are practiced and associated Satir communication model is taught to improve couple conflict resolution and communication under COVID-2019.
intervention type: Behavioral
intervention name: Cognitive and behavioral intervention.
description: Two hours group sessions including mindfulness and emotion regulation. The practice of mindfulness is taught to parents to become aware of their thoughts and emotion on the present moment. The behavioral intervention has parents develop an Positive Time-out for dealing with conflict and negativity, using strategies to down-regulate their own negative emotions.
arm group label: Parent-child Relationship Intervention
intervention type: Behavioral
intervention name: Problem-solving and relationship improvement intervention.
description: Two hours group sessions including problem-solving and improving marital relationship . In the problem-solving part, the knowledge and techniques of problem-solving are taught to couple. relationship improvement part which promote the couple relationship by being aware of their own and their partner's deep-seated needs and communicating in a congruent way.
arm group label: Couple Relationship Intervention
criteria: 
gender: All
minimum age: 30 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Beijing Normal University
investigator full name: Xiuyun Lin
investigator title: professor
mesh term: COVID-19
sharing ipd: No