<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/NCT03282071</url>
  </required_header>
  <id_info>
    <org_study_id>SPH-MHP-FWS01</org_study_id>
    <nct_id>NCT03282071</nct_id>
  </id_info>
  <brief_title>Joyful Parenting Pilot Project RCT Study</brief_title>
  <official_title>Community-based Mental Wellness Project for Adolescents and Adults: Joyful Parenting Pilot Project RCT Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hong Kong Family Welfare Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The 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>
      Aims: To enhance mental well-being of adolescents, adults and their families by creating a&#xD;
      positive, happy and joyful environment in the community.&#xD;
&#xD;
      Targets: Parents aged 12-59 and their family members in Hong Kong.&#xD;
&#xD;
      Methods: Joyful Parenting Pilot Project will adopt the public health and family-focused&#xD;
      approach, under the brand name of &quot;Joyful@HK Campaign&quot;. Evidence-based and Evidence&#xD;
      Generating approach with vigorous study design, both qualitative (e.g. focus groups) and&#xD;
      quantitative (e.g. randomised controlled trial), will be used to evaluate the overall&#xD;
      programme effectiveness including follow-up of at least one month (&quot;best science&quot;). To ensure&#xD;
      the practicability and sustainability of the CBEP, we will engage community partners with&#xD;
      strong track records of &quot;best practice&quot; to design, plan, and implement the intervention. This&#xD;
      project will use innovative and integrated positive psychology and public health theories and&#xD;
      methods to plan brief, simple, and cost-effective intervention.&#xD;
&#xD;
      Significance: By using &quot;best science&quot; in the design and evaluation of intervention programme,&#xD;
      and the &quot;best practice&quot; of the partners' skills, experience and strong connection with&#xD;
      service targets in the community, the intervention, if proven to be effective, for promoting&#xD;
      sharing, mind and enjoyment and enhancing mental wellbeing can be further developed and&#xD;
      widely disseminated to and adopted by the practitioners in the health and social service&#xD;
      sectors for replication and improvement to benefit the whole population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Joyful Parenting Pilot Project is part of the Community-based Mental Wellness Project for&#xD;
      Adolescents and Adults, which aims at enhancing mental well-being of adolescents, adults and&#xD;
      their families by creating a positive, happy and joyful environment in the community. The&#xD;
      Project is funded by Health Care and Promotion Fund of Food and Health Bureau.&#xD;
&#xD;
      Joyful Parenting Pilot Project is organized by the Hong Kong Family Welfare Society and led&#xD;
      by the School of Public Health, The University of Hong Kong (HKU). The project will organize&#xD;
      two-session interactive talks for parents to promote praise and appreciation, positive&#xD;
      thinking, enjoyable parenting and knowledge of adult mental health problem (in particular the&#xD;
      mixed anxiety and depressive disorder) and mental well-being; and one family gathering&#xD;
      activity to promote and practice quality family communication. One wisdom sharing session&#xD;
      will be organized for social workers and service practitioners to promote best practice of&#xD;
      community mental wellness project.&#xD;
&#xD;
      The major subjects of the Joyful Parenting Pilot Project RCT Study are 120 parents and at&#xD;
      least 240 family members. 4 family service units of Hong Kong Family Welfare Society will&#xD;
      either be assigned into intervention groups or wait-list control groups. Cluster Randomized&#xD;
      Controlled Trial will be used to evaluate the effectiveness of the intervention programme.&#xD;
&#xD;
      In the study, parents and their family members will be invited to complete questionnaires to&#xD;
      measure the behavioral indicators of sharing, mind and enjoyment, and mental well-being&#xD;
      and/or invited to attend the focus group to understand the participants' experience during&#xD;
      the programme while community partners will be invited to individual in-depth interviews. HKU&#xD;
      team will conduct evaluation during the programme implementation stage. The effectiveness of&#xD;
      the intervention, as well as the level of participation and ratings for the intervention will&#xD;
      also be evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 21, 2017</start_date>
  <completion_date type="Actual">November 30, 2018</completion_date>
  <primary_completion_date type="Actual">June 30, 2018</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sharing (Praise), Mind (Appreciation) and Enjoyment (SME) Related Behaviours</measure>
    <time_frame>T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow-up after baseline</time_frame>
    <description>Outcome-based questionnaire will be used to evaluate participants' frequency of performing the suggested Sharing, Mind and Enjoyment (SME) related behaviours from baseline to three-month after baseline.&#xD;
Praise: 3-item (range: 0-21). Higher scores mean a better outcome. Appreciation: 2-item (range: 0-14). Higher scores mean a better outcome. Enjoyment: 2-item (range: 0-14). Higher scores mean a better outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in Subjective Happiness From Baseline to Three-month After Baseline</measure>
    <time_frame>T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline</time_frame>
    <description>Subjective Happiness Scale (4 items) (1-7): higher scores mean a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Mental Well-being From Baseline to Three-month After Baseline</measure>
    <time_frame>T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline</time_frame>
    <description>Validated Chinese version of 7-item Warwick Edinburgh Well-being Scale (7-35): higher scores indicated higher level of wellbeing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Family Relationship From Baseline to Three-month After Baseline</measure>
    <time_frame>T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline</time_frame>
    <description>Respondents rated each item from 0 (no understanding / intimacy / communication at all with family members) to 10 (full understanding / intimacy / communication with family members), resulting in a total score of 0-30, with higher scores indicating better family relationship.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Personal and Family Health From Baseline to Three-month After Baseline</measure>
    <time_frame>T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline</time_frame>
    <description>Respondents rated each item from 0 (not at all healthy) to 10 (very healthy), with higher scores indicating higher level of personal/family health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Personal and Family Happiness From Baseline to Three-month After Baseline</measure>
    <time_frame>T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline</time_frame>
    <description>Respondents rated each item from 0 (not at all happy) to 10 (very happy), with higher scores indicating higher level of personal/family happiness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Family Harmony From Baseline to Three-month After Baseline</measure>
    <time_frame>T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline</time_frame>
    <description>Respondents rated each item from 0 (not at all harmonious) to 10 (very harmonious), with higher scores indicating higher level of family harmony.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Knowledge and Perception of Mixed Anxiety and Depressive Disorders</measure>
    <time_frame>T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline</time_frame>
    <description>The knowledge and understandings of MADD was self-developed to assess the level of awareness of the MADD symptoms (&quot;I know the symptoms of MADD&quot;, range 0 to 10), intention to seek help (&quot;I will talk to families or friends when I have emotional disturbance&quot;, range 0-10), self-efficacy of help seeking (&quot;I know how to seek help when I have emotional disturbance&quot;, range 0-10), and understanding of the MADD definition (&quot;MADD refers to the condition when both anxiety and depression are diagnosed&quot;, yes/no/uncertain).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction Towards Joyful Parenting Intervention Programme</measure>
    <time_frame>T2: after 1st talk; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline</time_frame>
    <description>Satisfaction towards programme will be assessed by program evaluation measures: rated on a 0-10 scale, with &quot;0&quot; indicating &quot;unsatisfied&quot; and &quot;10&quot; indicating &quot;satisfied&quot;.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">144</enrollment>
  <condition>Mental Well-being</condition>
  <condition>Happiness</condition>
  <arm_group>
    <arm_group_label>Joyful Parenting Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will participate in two-session interactive talks on joyful parenting (a core session intervention and booster intervention) and one family gathering activity; questionnaire evaluation will be conducted at baseline, post-session,1 month and 3 month after core session.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention will be provided to control groups during study period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Joyful Parenting Intervention</intervention_name>
    <description>Two-session interactive talks for parents to promote praise &amp; appreciation, positive thinking, enjoyable parenting (mind) and knowledge of adult mental health problem (in particular the mixed anxiety and depressive disorder) and mental well-being.&#xD;
One family gathering activity (e.g. outdoor / visit / family indoor gathering) to promote and practise quality family communication (enjoyment and sharing).</description>
    <arm_group_label>Joyful Parenting Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Parents (major subjects):&#xD;
&#xD;
               -  Parents aged 18-59 (including single parents)&#xD;
&#xD;
               -  Chinese speaking&#xD;
&#xD;
               -  Able to complete questionnaires/ focus groups&#xD;
&#xD;
          2. Their family members:&#xD;
&#xD;
               -  Family members of those parents who have already participated in the Joyful&#xD;
                  Parenting Pilot Project (Their family members could be children/ adolescents)&#xD;
&#xD;
               -  Chinese speaking&#xD;
&#xD;
               -  Able to complete questionnaires/ focus groups&#xD;
&#xD;
          3. Community partners&#xD;
&#xD;
               -  Staff of Integrated Family Service Units, under Hong Kong Family Welfare Society&#xD;
                  in partnership with HKU research team, who organize, plan or implement the&#xD;
                  project&#xD;
&#xD;
               -  Adults aged 18 or above&#xD;
&#xD;
               -  Chinese speaking&#xD;
&#xD;
               -  Able to complete questionnaires/ individual in-depth interviews&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those who cannot read Chinese&#xD;
&#xD;
          -  Those who suffered from severe mental illness&#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>Yuying Sun</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hong Kong Family Welfare Society- North Point Integrated Family Service Centre</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hong Kong Family Welfare Society- Yau Tong Integrated Family Service Centre</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <results_first_submitted>March 23, 2020</results_first_submitted>
  <results_first_submitted_qc>November 3, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">November 25, 2020</results_first_posted>
  <last_update_submitted>November 3, 2020</last_update_submitted>
  <last_update_submitted_qc>November 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Dr Sun Yuying</investigator_full_name>
    <investigator_title>Post-doctoral Fellow</investigator_title>
  </responsible_party>
  <keyword>Mental health</keyword>
  <keyword>Mental well-being</keyword>
  <keyword>Community-based engagement</keyword>
  <keyword>Positive psychology</keyword>
  <keyword>Public health approach</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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>June 1, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/71/NCT03282071/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>recruitment period: Aug-Oct 2017; types of location: family service centres</recruitment_details>
      <pre_assignment_details>8 parents excluded (not meeting inclusion criteria 18-59 years)</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Joyful Parenting Intervention</title>
          <description>Two sessions of interactive talks were included with each lasted for 2 hours. The contents included praise and appreciation skills, enjoyable parenting through family games and knowledge of Mixed Anxiety and Depressive Disorder (MADD).&#xD;
After around 3 months, a family gathering activity also involving the children and other family members was organized as an incentive for the parents.</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>No intervention were provided to control groups during assessment period.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="75"/>
                <participants group_id="P2" count="69"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="65"/>
                <participants group_id="P2" count="60"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Joyful Parenting Intervention</title>
          <description>Two sessions of interactive talks were included with each lasted for 2 hours. The contents included praise and appreciation skills, enjoyable parenting through family games and knowledge of Mixed Anxiety and Depressive Disorder (MADD).&#xD;
After around 3 months, a family gathering activity also involving the children and other family members was organized as an incentive for the parents.</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>No intervention were provided to control groups during study period.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="75"/>
            <count group_id="B2" value="69"/>
            <count group_id="B3" value="144"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Age</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="75"/>
                    <count group_id="B2" value="69"/>
                    <count group_id="B3" value="144"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41.8" spread="5.51"/>
                    <measurement group_id="B2" value="43.3" spread="6.19"/>
                    <measurement group_id="B3" value="42.5" spread="5.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="75"/>
                    <count group_id="B2" value="69"/>
                    <count group_id="B3" value="144"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                    <measurement group_id="B2" value="64"/>
                    <measurement group_id="B3" value="122"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Birthplace</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Hong Kong</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="75"/>
                    <count group_id="B2" value="69"/>
                    <count group_id="B3" value="144"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Guangdong Province</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="75"/>
                    <count group_id="B2" value="69"/>
                    <count group_id="B3" value="144"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other places</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="75"/>
                    <count group_id="B2" value="69"/>
                    <count group_id="B3" value="144"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Sharing (Praise), Mind (Appreciation) and Enjoyment (SME) Related Behaviours</title>
        <description>Outcome-based questionnaire will be used to evaluate participants' frequency of performing the suggested Sharing, Mind and Enjoyment (SME) related behaviours from baseline to three-month after baseline.&#xD;
Praise: 3-item (range: 0-21). Higher scores mean a better outcome. Appreciation: 2-item (range: 0-14). Higher scores mean a better outcome. Enjoyment: 2-item (range: 0-14). Higher scores mean a better outcome.</description>
        <time_frame>T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow-up after baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Joyful Parenting Intervention</title>
            <description>Two sessions of interactive talks were included with each lasted for 2 hours. The contents included praise and appreciation skills, enjoyable parenting through family games and knowledge of Mixed Anxiety and Depressive Disorder (MADD).&#xD;
After around 3 months, a family gathering activity also involving the children and other family members was organized as an incentive for the parents.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>No intervention will be provided to control groups during study period.</description>
          </group>
        </group_list>
        <measure>
          <title>Sharing (Praise), Mind (Appreciation) and Enjoyment (SME) Related Behaviours</title>
          <description>Outcome-based questionnaire will be used to evaluate participants' frequency of performing the suggested Sharing, Mind and Enjoyment (SME) related behaviours from baseline to three-month after baseline.&#xD;
Praise: 3-item (range: 0-21). Higher scores mean a better outcome. Appreciation: 2-item (range: 0-14). Higher scores mean a better outcome. Enjoyment: 2-item (range: 0-14). Higher scores mean a better outcome.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="75"/>
                <count group_id="O2" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Sharing (Praise) at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.49" spread="5.15"/>
                    <measurement group_id="O2" value="11.34" spread="4.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sharing (Praise) at 1-month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.23" spread="4.91"/>
                    <measurement group_id="O2" value="11.05" spread="4.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sharing (Praise) at 3-month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.09" spread="4.12"/>
                    <measurement group_id="O2" value="12.34" spread="4.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mind (Appreciation) at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.03" spread="3.72"/>
                    <measurement group_id="O2" value="7.86" spread="3.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mind (Appreciation) at 1-month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.37" spread="3.66"/>
                    <measurement group_id="O2" value="8.44" spread="3.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mind (Appreciation) at 3-month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.86" spread="2.81"/>
                    <measurement group_id="O2" value="7.83" spread="2.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Enjoyment at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.78" spread="3.78"/>
                    <measurement group_id="O2" value="7.42" spread="3.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Enjoyment at 1-month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.82" spread="3.22"/>
                    <measurement group_id="O2" value="7.58" spread="3.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Enjoyment at 3-month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.92" spread="3.31"/>
                    <measurement group_id="O2" value="7.75" spread="2.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Subjective Happiness From Baseline to Three-month After Baseline</title>
        <description>Subjective Happiness Scale (4 items) (1-7): higher scores mean a better outcome.</description>
        <time_frame>T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Joyful Parenting Intervention</title>
            <description>Two sessions of interactive talks were included with each lasted for 2 hours. The contents included praise and appreciation skills, enjoyable parenting through family games and knowledge of Mixed Anxiety and Depressive Disorder (MADD).&#xD;
After around 3 months, a family gathering activity also involving the children and other family members was organized as an incentive for the parents.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>No intervention will be provided to control groups during assessment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Subjective Happiness From Baseline to Three-month After Baseline</title>
          <description>Subjective Happiness Scale (4 items) (1-7): higher scores mean a better outcome.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="75"/>
                <count group_id="O2" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Subjective Happiness at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.47" spread="1.19"/>
                    <measurement group_id="O2" value="4.52" spread="1.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjective Happiness at 1-month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.03" spread="1.10"/>
                    <measurement group_id="O2" value="4.54" spread="1.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjective Happiness at 3-month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.12" spread="0.93"/>
                    <measurement group_id="O2" value="4.64" spread="1.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Mental Well-being From Baseline to Three-month After Baseline</title>
        <description>Validated Chinese version of 7-item Warwick Edinburgh Well-being Scale (7-35): higher scores indicated higher level of wellbeing.</description>
        <time_frame>T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Joyful Parenting Intervention</title>
            <description>Two sessions of interactive talks were included with each lasted for 2 hours. The contents included praise and appreciation skills, enjoyable parenting through family games and knowledge of Mixed Anxiety and Depressive Disorder (MADD).&#xD;
After around 3 months, a family gathering activity also involving the children and other family members was organized as an incentive for the parents.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>No intervention will be provided to control groups during assessment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Mental Well-being From Baseline to Three-month After Baseline</title>
          <description>Validated Chinese version of 7-item Warwick Edinburgh Well-being Scale (7-35): higher scores indicated higher level of wellbeing.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="75"/>
                <count group_id="O2" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mental well-being at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.82" spread="3.8"/>
                    <measurement group_id="O2" value="23.82" spread="4.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mental well-being at 1-month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.81" spread="3.94"/>
                    <measurement group_id="O2" value="24.67" spread="3.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mental well-being at 3-month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.32" spread="3.83"/>
                    <measurement group_id="O2" value="24.81" spread="4.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Family Relationship From Baseline to Three-month After Baseline</title>
        <description>Respondents rated each item from 0 (no understanding / intimacy / communication at all with family members) to 10 (full understanding / intimacy / communication with family members), resulting in a total score of 0-30, with higher scores indicating better family relationship.</description>
        <time_frame>T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Joyful Parenting Intervention</title>
            <description>Two sessions of interactive talks were included with each lasted for 2 hours. The contents included praise and appreciation skills, enjoyable parenting through family games and knowledge of Mixed Anxiety and Depressive Disorder (MADD).&#xD;
After around 3 months, a family gathering activity also involving the children and other family members was organized as an incentive for the parents.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>No intervention will be provided to control groups during assessment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Family Relationship From Baseline to Three-month After Baseline</title>
          <description>Respondents rated each item from 0 (no understanding / intimacy / communication at all with family members) to 10 (full understanding / intimacy / communication with family members), resulting in a total score of 0-30, with higher scores indicating better family relationship.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="75"/>
                <count group_id="O2" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Family relationship at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.71" spread="6.80"/>
                    <measurement group_id="O2" value="20.85" spread="5.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Family relationship at 1-month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.36" spread="5.03"/>
                    <measurement group_id="O2" value="20.73" spread="4.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Family relationship at 3-month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.06" spread="4.69"/>
                    <measurement group_id="O2" value="20.34" spread="5.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Personal and Family Health From Baseline to Three-month After Baseline</title>
        <description>Respondents rated each item from 0 (not at all healthy) to 10 (very healthy), with higher scores indicating higher level of personal/family health.</description>
        <time_frame>T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Joyful Parenting Intervention</title>
            <description>Two sessions of interactive talks were included with each lasted for 2 hours. The contents included praise and appreciation skills, enjoyable parenting through family games and knowledge of Mixed Anxiety and Depressive Disorder (MADD).&#xD;
After around 3 months, a family gathering activity also involving the children and other family members was organized as an incentive for the parents.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>No intervention will be provided to control groups during assessment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Personal and Family Health From Baseline to Three-month After Baseline</title>
          <description>Respondents rated each item from 0 (not at all healthy) to 10 (very healthy), with higher scores indicating higher level of personal/family health.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="75"/>
                <count group_id="O2" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Personal health at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.15" spread="2.05"/>
                    <measurement group_id="O2" value="6.10" spread="2.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Personal health at 1-month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.99" spread="2.04"/>
                    <measurement group_id="O2" value="6.18" spread="2.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Personal health at 3-month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.29" spread="1.84"/>
                    <measurement group_id="O2" value="6.32" spread="2.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Family health at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.25" spread="2.32"/>
                    <measurement group_id="O2" value="6.25" spread="2.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Family health at 1-month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.23" spread="1.87"/>
                    <measurement group_id="O2" value="6.48" spread="1.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Family health at 3-month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.33" spread="1.66"/>
                    <measurement group_id="O2" value="6.50" spread="1.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Personal and Family Happiness From Baseline to Three-month After Baseline</title>
        <description>Respondents rated each item from 0 (not at all happy) to 10 (very happy), with higher scores indicating higher level of personal/family happiness.</description>
        <time_frame>T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Joyful Parenting Intervention</title>
            <description>Two sessions of interactive talks were included with each lasted for 2 hours. The contents included praise and appreciation skills, enjoyable parenting through family games and knowledge of Mixed Anxiety and Depressive Disorder (MADD).&#xD;
After around 3 months, a family gathering activity also involving the children and other family members was organized as an incentive for the parents.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>No intervention will be provided to control groups during assessment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Personal and Family Happiness From Baseline to Three-month After Baseline</title>
          <description>Respondents rated each item from 0 (not at all happy) to 10 (very happy), with higher scores indicating higher level of personal/family happiness.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="75"/>
                <count group_id="O2" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Personal happiness at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.15" spread="2.31"/>
                    <measurement group_id="O2" value="6.15" spread="2.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Personal happiness at 1-month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.97" spread="1.99"/>
                    <measurement group_id="O2" value="6.45" spread="2.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Personal happiness at 3-month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.25" spread="1.79"/>
                    <measurement group_id="O2" value="6.37" spread="2.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Family happiness at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.40" spread="2.54"/>
                    <measurement group_id="O2" value="6.37" spread="2.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Family happiness at 1-month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.38" spread="1.99"/>
                    <measurement group_id="O2" value="6.55" spread="1.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Family happiness at 3-month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.45" spread="1.67"/>
                    <measurement group_id="O2" value="6.46" spread="1.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Family Harmony From Baseline to Three-month After Baseline</title>
        <description>Respondents rated each item from 0 (not at all harmonious) to 10 (very harmonious), with higher scores indicating higher level of family harmony.</description>
        <time_frame>T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Joyful Parenting Intervention</title>
            <description>Two sessions of interactive talks were included with each lasted for 2 hours. The contents included praise and appreciation skills, enjoyable parenting through family games and knowledge of Mixed Anxiety and Depressive Disorder (MADD).&#xD;
After around 3 months, a family gathering activity also involving the children and other family members was organized as an incentive for the parents.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>No intervention will be provided to control groups during assessment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Family Harmony From Baseline to Three-month After Baseline</title>
          <description>Respondents rated each item from 0 (not at all harmonious) to 10 (very harmonious), with higher scores indicating higher level of family harmony.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="75"/>
                <count group_id="O2" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Family harmony at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.23" spread="2.59"/>
                    <measurement group_id="O2" value="6.49" spread="2.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Family harmony at 1-month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.20" spread="2.09"/>
                    <measurement group_id="O2" value="6.80" spread="1.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Family harmony at 3-month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.39" spread="1.89"/>
                    <measurement group_id="O2" value="6.63" spread="1.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Knowledge and Perception of Mixed Anxiety and Depressive Disorders</title>
        <description>The knowledge and understandings of MADD was self-developed to assess the level of awareness of the MADD symptoms (&quot;I know the symptoms of MADD&quot;, range 0 to 10), intention to seek help (&quot;I will talk to families or friends when I have emotional disturbance&quot;, range 0-10), self-efficacy of help seeking (&quot;I know how to seek help when I have emotional disturbance&quot;, range 0-10), and understanding of the MADD definition (&quot;MADD refers to the condition when both anxiety and depression are diagnosed&quot;, yes/no/uncertain).</description>
        <time_frame>T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Joyful Parenting Intervention</title>
            <description>Two sessions of interactive talks were included with each lasted for 2 hours. The contents included praise and appreciation skills, enjoyable parenting through family games and knowledge of Mixed Anxiety and Depressive Disorder (MADD).&#xD;
After around 3 months, a family gathering activity also involving the children and other family members was organized as an incentive for the parents.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>No intervention were provided to control groups during study period.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Knowledge and Perception of Mixed Anxiety and Depressive Disorders</title>
          <description>The knowledge and understandings of MADD was self-developed to assess the level of awareness of the MADD symptoms (&quot;I know the symptoms of MADD&quot;, range 0 to 10), intention to seek help (&quot;I will talk to families or friends when I have emotional disturbance&quot;, range 0-10), self-efficacy of help seeking (&quot;I know how to seek help when I have emotional disturbance&quot;, range 0-10), and understanding of the MADD definition (&quot;MADD refers to the condition when both anxiety and depression are diagnosed&quot;, yes/no/uncertain).</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="75"/>
                <count group_id="O2" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>The awareness of MADD symptoms at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.85" spread="2.61"/>
                    <measurement group_id="O2" value="5.30" spread="2.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>The awareness of MADD symptoms at 1-month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.33" spread="1.81"/>
                    <measurement group_id="O2" value="4.95" spread="2.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>The awareness of MADD symptoms at 3-month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.23" spread="2.07"/>
                    <measurement group_id="O2" value="5.50" spread="2.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intention to seek help at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.28" spread="2.44"/>
                    <measurement group_id="O2" value="7.05" spread="2.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intention to seek help at 1-month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.47" spread="1.88"/>
                    <measurement group_id="O2" value="7.18" spread="2.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intention to seek help at 3-month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.72" spread="1.95"/>
                    <measurement group_id="O2" value="7.14" spread="2.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Self-efficacy at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.94" spread="2.36"/>
                    <measurement group_id="O2" value="7.07" spread="2.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Self-efficacy at 1-month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.50" spread="2.01"/>
                    <measurement group_id="O2" value="7.24" spread="2.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Self-efficacy at 3-month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.89" spread="1.99"/>
                    <measurement group_id="O2" value="7.04" spread="2.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Satisfaction Towards Joyful Parenting Intervention Programme</title>
        <description>Satisfaction towards programme will be assessed by program evaluation measures: rated on a 0-10 scale, with &quot;0&quot; indicating &quot;unsatisfied&quot; and &quot;10&quot; indicating &quot;satisfied&quot;.</description>
        <time_frame>T2: after 1st talk; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Joyful Parenting Intervention</title>
            <description>Two sessions of interactive talks were included with each lasted for 2 hours. The contents included praise and appreciation skills, enjoyable parenting through family games and knowledge of Mixed Anxiety and Depressive Disorder (MADD).&#xD;
After around 3 months, a family gathering activity also involving the children and other family members was organized as an incentive for the parents.</description>
          </group>
        </group_list>
        <measure>
          <title>Satisfaction Towards Joyful Parenting Intervention Programme</title>
          <description>Satisfaction towards programme will be assessed by program evaluation measures: rated on a 0-10 scale, with &quot;0&quot; indicating &quot;unsatisfied&quot; and &quot;10&quot; indicating &quot;satisfied&quot;.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Satisfaction of the 1st talk at T2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.47" spread="1.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Satisfaction of the 2nd talk at 1-month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.48" spread="1.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Satisfaction of the family gathering at 3-month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.80" spread="1.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>No adverse event was observed at post-intervention (T2), 1-month (T3) or 3-month (T4).</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Joyful Parenting Intervention</title>
          <description>Two sessions of interactive talks were included with each lasted for 2 hours. The contents included praise and appreciation skills, enjoyable parenting through family games and knowledge of Mixed Anxiety and Depressive Disorder (MADD).&#xD;
After around 3 months, a family gathering activity also involving the children and other family members was organized as an incentive for the parents.</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>No intervention will be provided to control groups during study period.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Validated questionnaires were not available and many existing questionnaires were too long, we developed the outcome and impact-oriented questionnaires to assess the changes in the participants.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Yuying Sun</name_or_title>
      <organization>The University of Hong Kong</organization>
      <phone>(852)39179144</phone>
      <email>gyysun@hku.hk</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03282071
org study id: SPH-MHP-FWS01
nct id: NCT03282071
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Aims: To enhance mental well-being of adolescents, adults and their families by creating a
      positive, happy and joyful environment in the community.

      Targets: Parents aged 12-59 and their family members in Hong Kong.

      Methods: Joyful Parenting Pilot Project will adopt the public health and family-focused
      approach, under the brand name of "Joyful@HK Campaign". Evidence-based and Evidence
      Generating approach with vigorous study design, both qualitative (e.g. focus groups) and
      quantitative (e.g. randomised controlled trial), will be used to evaluate the overall
      programme effectiveness including follow-up of at least one month ("best science"). To ensure
      the practicability and sustainability of the CBEP, we will engage community partners with
      strong track records of "best practice" to design, plan, and implement the intervention. This
      project will use innovative and integrated positive psychology and public health theories and
      methods to plan brief, simple, and cost-effective intervention.

      Significance: By using "best science" in the design and evaluation of intervention programme,
      and the "best practice" of the partners' skills, experience and strong connection with
      service targets in the community, the intervention, if proven to be effective, for promoting
      sharing, mind and enjoyment and enhancing mental wellbeing can be further developed and
      widely disseminated to and adopted by the practitioners in the health and social service
      sectors for replication and improvement to benefit the whole population.
Joyful Parenting Pilot Project is part of the Community-based Mental Wellness Project for
      Adolescents and Adults, which aims at enhancing mental well-being of adolescents, adults and
      their families by creating a positive, happy and joyful environment in the community. The
      Project is funded by Health Care and Promotion Fund of Food and Health Bureau.

      Joyful Parenting Pilot Project is organized by the Hong Kong Family Welfare Society and led
      by the School of Public Health, The University of Hong Kong (HKU). The project will organize
      two-session interactive talks for parents to promote praise and appreciation, positive
      thinking, enjoyable parenting and knowledge of adult mental health problem (in particular the
      mixed anxiety and depressive disorder) and mental well-being; and one family gathering
      activity to promote and practice quality family communication. One wisdom sharing session
      will be organized for social workers and service practitioners to promote best practice of
      community mental wellness project.

      The major subjects of the Joyful Parenting Pilot Project RCT Study are 120 parents and at
      least 240 family members. 4 family service units of Hong Kong Family Welfare Society will
      either be assigned into intervention groups or wait-list control groups. Cluster Randomized
      Controlled Trial will be used to evaluate the effectiveness of the intervention programme.

      In the study, parents and their family members will be invited to complete questionnaires to
      measure the behavioral indicators of sharing, mind and enjoyment, and mental well-being
      and/or invited to attend the focus group to understand the participants' experience during
      the programme while community partners will be invited to individual in-depth interviews. HKU
      team will conduct evaluation during the programme implementation stage. The effectiveness of
      the intervention, as well as the level of participation and ratings for the intervention will
      also be evaluated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Sharing (Praise), Mind (Appreciation) and Enjoyment (SME) Related Behaviours
time frame: T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow-up after baseline
description: Outcome-based questionnaire will be used to evaluate participants' frequency of performing the suggested Sharing, Mind and Enjoyment (SME) related behaviours from baseline to three-month after baseline.
Praise: 3-item (range: 0-21). Higher scores mean a better outcome. Appreciation: 2-item (range: 0-14). Higher scores mean a better outcome. Enjoyment: 2-item (range: 0-14). Higher scores mean a better outcome.
measure: Changes in Subjective Happiness From Baseline to Three-month After Baseline
time frame: T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
description: Subjective Happiness Scale (4 items) (1-7): higher scores mean a better outcome.
measure: Changes in Mental Well-being From Baseline to Three-month After Baseline
time frame: T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
description: Validated Chinese version of 7-item Warwick Edinburgh Well-being Scale (7-35): higher scores indicated higher level of wellbeing.
measure: Changes in Family Relationship From Baseline to Three-month After Baseline
time frame: T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
description: Respondents rated each item from 0 (no understanding / intimacy / communication at all with family members) to 10 (full understanding / intimacy / communication with family members), resulting in a total score of 0-30, with higher scores indicating better family relationship.
measure: Changes in Personal and Family Health From Baseline to Three-month After Baseline
time frame: T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
description: Respondents rated each item from 0 (not at all healthy) to 10 (very healthy), with higher scores indicating higher level of personal/family health.
measure: Changes in Personal and Family Happiness From Baseline to Three-month After Baseline
time frame: T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
description: Respondents rated each item from 0 (not at all happy) to 10 (very happy), with higher scores indicating higher level of personal/family happiness.
measure: Changes in Family Harmony From Baseline to Three-month After Baseline
time frame: T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
description: Respondents rated each item from 0 (not at all harmonious) to 10 (very harmonious), with higher scores indicating higher level of family harmony.
measure: Changes in Knowledge and Perception of Mixed Anxiety and Depressive Disorders
time frame: T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
description: The knowledge and understandings of MADD was self-developed to assess the level of awareness of the MADD symptoms ("I know the symptoms of MADD", range 0 to 10), intention to seek help ("I will talk to families or friends when I have emotional disturbance", range 0-10), self-efficacy of help seeking ("I know how to seek help when I have emotional disturbance", range 0-10), and understanding of the MADD definition ("MADD refers to the condition when both anxiety and depression are diagnosed", yes/no/uncertain).
measure: Satisfaction Towards Joyful Parenting Intervention Programme
time frame: T2: after 1st talk; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
description: Satisfaction towards programme will be assessed by program evaluation measures: rated on a 0-10 scale, with "0" indicating "unsatisfied" and "10" indicating "satisfied".
arm group label: Joyful Parenting Intervention
arm group type: Experimental
description: Subjects will participate in two-session interactive talks on joyful parenting (a core session intervention and booster intervention) and one family gathering activity; questionnaire evaluation will be conducted at baseline, post-session,1 month and 3 month after core session.
arm group label: Control
arm group type: No Intervention
description: No intervention will be provided to control groups during study period.
intervention type: Behavioral
intervention name: Joyful Parenting Intervention
description: Two-session interactive talks for parents to promote praise & appreciation, positive thinking, enjoyable parenting (mind) and knowledge of adult mental health problem (in particular the mixed anxiety and depressive disorder) and mental well-being.
One family gathering activity (e.g. outdoor / visit / family indoor gathering) to promote and practise quality family communication (enjoyment and sharing).
arm group label: Joyful Parenting Intervention
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Yuying Sun
role: Principal Investigator
affiliation: The University of Hong Kong
facility: 
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: The University of Hong Kong
investigator full name: Dr Sun Yuying
investigator title: Post-doctoral Fellow
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Validated questionnaires were not available and many existing questionnaires were too long, we developed the outcome and impact-oriented questionnaires to assess the changes in the participants.
point of contact: 