<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/NCT04427683</url>
  </required_header>
  <id_info>
    <org_study_id>SR2020.A6.004</org_study_id>
    <nct_id>NCT04427683</nct_id>
  </id_info>
  <brief_title>Effects of a Brief Mindful Parenting Program for Hong Kong Chinese Impacted by Social Unrest</brief_title>
  <acronym>MPHKC</acronym>
  <official_title>Effects of a Brief Mindful Parenting Program for Hong Kong Chinese Impacted by Social Unrest: A Randomised Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hong Kong Polytechnic University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Hong Kong Polytechnic 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>
      A four session mindful parenting workshop is designed to promote parental mental health&#xD;
      during the social unrest in 2020. This study is conducted to investigate the outcome of the&#xD;
      program. It is a randomised control trial design and will be conducted in five sites in Hong&#xD;
      Kong. An estimated 340 parents will be recruited and randomised into an intervention group&#xD;
      and a wait-list control group. The primary outcome is parental depression. Secondary outcomes&#xD;
      include parental anxiety and post-traumatic stress, negative emotions, family functioning,&#xD;
      family conflict and mindful parenting. Exposure to social unrest will be measured and the&#xD;
      relationship to mental health and effects of the program will be examined.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Design: With a self-administered screening for depression (PHQ-9), parents with a subclinical&#xD;
      cutoff score or above will be eligible to participate in a four-session parent workshop. The&#xD;
      same program will be provided in five locations in Hong Kong. A waitlist-control randomised&#xD;
      controlled trial will be used to evaluate the outcomes of the program. An estimated 340&#xD;
      parents will be recruited and randomised into an intervention group and a wait-list control&#xD;
      group. The sample estimation is based on an expected effect size of .33 for family&#xD;
      functioning in the PI's pilot study, with an estimated drop-out rate of 15%, a two-tailed α&#xD;
      error of 5%, 80% power, and a test of two independent groups.&#xD;
&#xD;
      Measures: (1) Exposure to social unrest will be measured using the Political Life Events&#xD;
      Scale. The scale contains 20 items related to stressful events, to which respondents report&#xD;
      exposure by answering yes or no. In view of the local context, only 16 items will be used.&#xD;
      (2) Negative emotions about social unrest will be measured by the three items developed by&#xD;
      Halperin et al. The items assess the intensity of negative emotions (hatred, anger, despair)&#xD;
      in the context of social unrest, with responses given on a Likert-type scale ranging from 1&#xD;
      (not at all) to 10 (very strong). (3) Depression and anxiety symptoms will be assessed by the&#xD;
      Patient Health Questionnaire (PHQ-9) and the Generalized Anxiety Disorder 7-item (GAD-7)&#xD;
      scale. (4) Traumatic stress will be assessed by the International Trauma Questionnaire (ITQ),&#xD;
      a 6-item self-report measure of the major symptoms of post-traumatic stress. The ITQ has been&#xD;
      translated into Chinese and validated for screening of post-traumatic stress. (5) Family&#xD;
      functioning will be assessed by the Family APGAR (Adaptation, Partnership, Growth, Affection,&#xD;
      Resolve) scale (APGAR). The 5-item scales uses a 3-point response scale (0 = hardly ever and&#xD;
      2 = almost always). A cutoff for severe family dysfunction is available for Chinese families.&#xD;
      (6) Family conflict will be measured by the Conflict Tactics Scale (CTS-2), a self-report&#xD;
      measure of behavioural assault or psychological aggression among family members. It has been&#xD;
      used in studies of conflict between adolescents and parents.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 15, 2020</start_date>
  <completion_date type="Actual">September 30, 2020</completion_date>
  <primary_completion_date type="Actual">September 30, 2020</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>Recruited and eligible participants will be randomised into an intervention group and a wait-list control group.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Depression</measure>
    <time_frame>Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).</time_frame>
    <description>Self-administered measure Patient Health Questionnaire (PHQ-9), 9 items, sum of scores range from 0 to 27, the higher the score, the more severe in depressive symptoms</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).</time_frame>
    <description>Self-administered measure Generalized Anxiety Disorder 7-item scale (GAD-7), 7 items, sum of scores from 0 to 21, the higher the score, the more severe in the anxiety symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-traumatic stress</measure>
    <time_frame>Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).</time_frame>
    <description>self-administered measure International Trauma Questionnaire (ITQ), 6 items, sum of scores range from 0 to 24, the higher the score, the more severe the post-traumatic stress symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>family functioning</measure>
    <time_frame>Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).</time_frame>
    <description>self-administered measure Family APGAR (Adaptation, Partnership, Growth, Affection, Resolve) scale (APGAR), 5 items, sum of the scores range from 0 to 10, the higher the score, the better in family functioning</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>family conflict</measure>
    <time_frame>Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).</time_frame>
    <description>self-administered measure Conflict Tactics Scale (CTS-2), 16 items, sum of scores range from 0 to 112, the higher the score, the more stronger intensity the family conflict is</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mindful parenting</measure>
    <time_frame>Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).</time_frame>
    <description>self administered measure, Interpersonal Mindfulness in Parenting scale, 6 items in nonjudgmental acceptance in parenting and 4 items in listening with full attention, sum of scores range from 6 to 30 for nonjudgmental acceptance in parenting, and 6 to 20 for listening with full attention, the higher the score, the stronger the interpersonal mindfulness level is</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Mental Health Issue</condition>
  <arm_group>
    <arm_group_label>Brief mindful parenting program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The program will consist of a four-session and last for eight hours integrating mindfulness skills and psychoeducation in managing stress under social unrest and promoting strategies for emotion regulation, conflict management, and self-care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait-list control group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>A four-minute educational video will be distributed to the participants who accept the randomisation. It includes brief information on mental health. After the participants from experimental group complete the intervention, those in wait-list control group will receive the same intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Brief mindful parenting program</intervention_name>
    <description>Mindfulness exercise include formal and informal mindfulness exercises, and additional exercise for coping with anger and arousing emotions. Psychoeducation includes understanding relationship between thoughts and feelings, fight or flight responses and adaptive coping in parenting relationship.</description>
    <arm_group_label>Brief mindful parenting program</arm_group_label>
    <arm_group_label>Wait-list control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  parents of adolescents at aged between 10 to 21&#xD;
&#xD;
          -  a score of PHQ-9 of 2 or above&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  parents with self-reported psychosis, alcohol or substance abuse, individual or family&#xD;
             crisis in last six months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Herman, Hay-ming LO, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hong Kong Polytechnic University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>LO, Herman Hay-ming</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>April 12, 2021</last_update_submitted>
  <last_update_submitted_qc>April 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>parent depression</keyword>
  <keyword>parent mental health</keyword>
  <keyword>mindfulness-based intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tooth, Impacted</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The protocol will be published in an open access academic journal.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 28, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/83/NCT04427683/Prot_SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 28, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/83/NCT04427683/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04427683
org study id: SR2020.A6.004
nct id: NCT04427683
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A four session mindful parenting workshop is designed to promote parental mental health
      during the social unrest in 2020. This study is conducted to investigate the outcome of the
      program. It is a randomised control trial design and will be conducted in five sites in Hong
      Kong. An estimated 340 parents will be recruited and randomised into an intervention group
      and a wait-list control group. The primary outcome is parental depression. Secondary outcomes
      include parental anxiety and post-traumatic stress, negative emotions, family functioning,
      family conflict and mindful parenting. Exposure to social unrest will be measured and the
      relationship to mental health and effects of the program will be examined.
Design: With a self-administered screening for depression (PHQ-9), parents with a subclinical
      cutoff score or above will be eligible to participate in a four-session parent workshop. The
      same program will be provided in five locations in Hong Kong. A waitlist-control randomised
      controlled trial will be used to evaluate the outcomes of the program. An estimated 340
      parents will be recruited and randomised into an intervention group and a wait-list control
      group. The sample estimation is based on an expected effect size of .33 for family
      functioning in the PI's pilot study, with an estimated drop-out rate of 15%, a two-tailed α
      error of 5%, 80% power, and a test of two independent groups.

      Measures: (1) Exposure to social unrest will be measured using the Political Life Events
      Scale. The scale contains 20 items related to stressful events, to which respondents report
      exposure by answering yes or no. In view of the local context, only 16 items will be used.
      (2) Negative emotions about social unrest will be measured by the three items developed by
      Halperin et al. The items assess the intensity of negative emotions (hatred, anger, despair)
      in the context of social unrest, with responses given on a Likert-type scale ranging from 1
      (not at all) to 10 (very strong). (3) Depression and anxiety symptoms will be assessed by the
      Patient Health Questionnaire (PHQ-9) and the Generalized Anxiety Disorder 7-item (GAD-7)
      scale. (4) Traumatic stress will be assessed by the International Trauma Questionnaire (ITQ),
      a 6-item self-report measure of the major symptoms of post-traumatic stress. The ITQ has been
      translated into Chinese and validated for screening of post-traumatic stress. (5) Family
      functioning will be assessed by the Family APGAR (Adaptation, Partnership, Growth, Affection,
      Resolve) scale (APGAR). The 5-item scales uses a 3-point response scale (0 = hardly ever and
      2 = almost always). A cutoff for severe family dysfunction is available for Chinese families.
      (6) Family conflict will be measured by the Conflict Tactics Scale (CTS-2), a self-report
      measure of behavioural assault or psychological aggression among family members. It has been
      used in studies of conflict between adolescents and parents.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Recruited and eligible participants will be randomised into an intervention group and a wait-list control group.
primary purpose: Treatment
masking: None (Open Label)
measure: Depression
time frame: Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).
description: Self-administered measure Patient Health Questionnaire (PHQ-9), 9 items, sum of scores range from 0 to 27, the higher the score, the more severe in depressive symptoms
measure: Anxiety
time frame: Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).
description: Self-administered measure Generalized Anxiety Disorder 7-item scale (GAD-7), 7 items, sum of scores from 0 to 21, the higher the score, the more severe in the anxiety symptoms
measure: Post-traumatic stress
time frame: Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).
description: self-administered measure International Trauma Questionnaire (ITQ), 6 items, sum of scores range from 0 to 24, the higher the score, the more severe the post-traumatic stress symptoms
measure: family functioning
time frame: Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).
description: self-administered measure Family APGAR (Adaptation, Partnership, Growth, Affection, Resolve) scale (APGAR), 5 items, sum of the scores range from 0 to 10, the higher the score, the better in family functioning
measure: family conflict
time frame: Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).
description: self-administered measure Conflict Tactics Scale (CTS-2), 16 items, sum of scores range from 0 to 112, the higher the score, the more stronger intensity the family conflict is
measure: mindful parenting
time frame: Change from pre-intervention (T0), to 1-month follow up (T1), and to 3-month follow-up (T2).
description: self administered measure, Interpersonal Mindfulness in Parenting scale, 6 items in nonjudgmental acceptance in parenting and 4 items in listening with full attention, sum of scores range from 6 to 30 for nonjudgmental acceptance in parenting, and 6 to 20 for listening with full attention, the higher the score, the stronger the interpersonal mindfulness level is
arm group label: Brief mindful parenting program
arm group type: Experimental
description: The program will consist of a four-session and last for eight hours integrating mindfulness skills and psychoeducation in managing stress under social unrest and promoting strategies for emotion regulation, conflict management, and self-care.
arm group label: Wait-list control group
arm group type: Other
description: A four-minute educational video will be distributed to the participants who accept the randomisation. It includes brief information on mental health. After the participants from experimental group complete the intervention, those in wait-list control group will receive the same intervention.
intervention type: Behavioral
intervention name: Brief mindful parenting program
description: Mindfulness exercise include formal and informal mindfulness exercises, and additional exercise for coping with anger and arousing emotions. Psychoeducation includes understanding relationship between thoughts and feelings, fight or flight responses and adaptive coping in parenting relationship.
arm group label: Brief mindful parenting program
arm group label: Wait-list control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Herman, Hay-ming LO, PhD
role: Principal Investigator
affiliation: Hong Kong Polytechnic University
facility: 
country: Hong Kong
responsible party type: Sponsor
mesh term: Tooth, Impacted
sharing ipd: No
ipd description: The protocol will be published in an open access academic journal.
provided document: 
provided document: 