<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/NCT02986009</url>
  </required_header>
  <id_info>
    <org_study_id>FC2016</org_study_id>
    <nct_id>NCT02986009</nct_id>
  </id_info>
  <brief_title>Be Good Parents (Parent Education)</brief_title>
  <official_title>Be Good Parents (Parent Education)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>City University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>International Social Service Hong Kong Branch</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>City University of Hong Kong</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>
      The collaborator has its vision as &quot;To have children, individuals, families and migrants&#xD;
      across countries live in dignity and harmony, and be contributing members to a just, humane&#xD;
      and caring society.&quot; Parents are very significant in the families as they need nurturing,&#xD;
      discipline, teaching, monitoring, and managing their children as well as their families.&#xD;
      Capable and competent parents bring good child outcome and happy family. The investigators&#xD;
      planned to serve targeted parents in two areas as 1. Emotion management and 2. Information on&#xD;
      community resource. In the first set, the participants are expected to improve their emotion&#xD;
      management leading to a more effective parenting. In the second set, the participants would&#xD;
      acquire more information that enables them to better use the community resources.&#xD;
&#xD;
      To work closely with the collaborator, and based on the previous results of an effective&#xD;
      parenting intervention, the investigators will modify the intervention to tailor the needs of&#xD;
      targeted parents. The objectives are:&#xD;
&#xD;
        1. After completing the parenting intervention, 150 participants will, 1.1. To increase&#xD;
           participants' emotion management strategies by 20%, 1.2. To enhance positive affect by&#xD;
           10%, 1.3. To decrease negative affect by 10%, 1.4. To enhance satisfaction with the&#xD;
           parent-child relationship by 10%, 1.5. To increase subjective happiness by 8%, 1.6. To&#xD;
           enhance family harmony by 5%, These levels of positive effects of the program were&#xD;
           projected from the investigators' published findings.&#xD;
&#xD;
        2. After joining the information sessions about education, health care, housing,&#xD;
           employment, and community facilities, another 150 participants will, 2.1 To know more&#xD;
           information of Hong Kong by 50%, 2.2 To know more information of Mainland China by 50%,&#xD;
           2.3 To use more community resources either in Hong Kong or Mainland China by 50%.&#xD;
&#xD;
      To study the effectiveness of parenting intervention, the investigators proposed to use a&#xD;
      randomized controlled trial (RCT) that is a type of scientific study to reduce bias.&#xD;
      Participants in this project will be randomly allocated to either the emotional management&#xD;
      group or the information group. As the information group has no focus on parenting,&#xD;
      participants would show no significant improvement in emotion management strategies or&#xD;
      satisfaction with the parent-child relationship, etc. Meanwhile, participants in the&#xD;
      parenting intervention would show no significant improvement in knowledge about either Hong&#xD;
      Kong or Mainland China.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Parenting not only acts as an important drive for child development, also serves as one of&#xD;
      the key determinants for family relationships. Emotion management is the essence of parenting&#xD;
      competence. Anger, fear, joy, distress and enthusiasm are involved in the parenting process.&#xD;
      Negative emotions of parents are associated with child abuse; while positive emotions are&#xD;
      related to warm parenting, and promote children's early attachment with parents. In addition,&#xD;
      parental negative emotion consistently predicts behavior problems of children. For example,&#xD;
      children who are exposed to higher levels of maternal negative feelings, such as anger, have&#xD;
      more difficulty regulating their own negative feelings and have greater difficulty getting&#xD;
      along with others.&#xD;
&#xD;
      Emotion management training has been shown effective in improving parenting skills, promoting&#xD;
      parent-child interaction, and preventing child abuse. For example, parents who attended anger&#xD;
      control workshops reported less unrealistic expectations for their children, fewer conflicts&#xD;
      with children, and less domestic violence toward spouse and children. However, these&#xD;
      interventions were tested in Western culture where there is much less emphasis on academic&#xD;
      performance of children. In addition, such interventions usually contain complex content and&#xD;
      last for months.&#xD;
&#xD;
      The investigators developed a parenting intervention tailored for Chinese parents and&#xD;
      reported its effectiveness in a randomized controlled trial. In this empirical study, 412&#xD;
      Hong Kong mothers of children aged 6 to 8 years old were randomized into the parenting arm or&#xD;
      the control arm. The results showed that the parenting arm reported greater increase in the&#xD;
      use of emotion management found that it was effective in increasing emotion management skills&#xD;
      and enhancing the parent-child relationship. Participants in the parenting arm also reported&#xD;
      lower negative affect, and higher positive affect, satisfaction with the parent-child&#xD;
      relationship, and family harmony, compared to the control arm. The investigators' findings&#xD;
      provide evidence for a sustainable, preventive, culturally appropriate, and cognitive&#xD;
      behavioral-based parenting program in the community population. Considering unique dynamics&#xD;
      of cross-boundary and new arrival families, a short and simple intervention on emotion&#xD;
      management would benefit these parents to perform better parenting. Therefore based on the&#xD;
      investigators' promising findings in the community setting, this proposed program aim to&#xD;
      modify this parenting program to the needs of parents of the cross-boundary and new arrival&#xD;
      children.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2, 2017</start_date>
  <completion_date type="Actual">January 15, 2018</completion_date>
  <primary_completion_date type="Actual">November 29, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of emotion management strategies as assessed by 10 self-developed items</measure>
    <time_frame>1 month</time_frame>
    <description>Example items include &quot;stop thinking about the situation and do something else&quot;, &quot;relax to calm down&quot;, &quot;think of the reasons for child's behavior&quot;, &quot;talk to family or friends&quot;, and &quot;manage anger when child misbehaves&quot;</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Positive and negative affect as assessed by 10 items from the Positive and Negative Affect Schedule</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with parent-child relationship as assessed by a single item from the Kansas Marital Satisfaction Scale</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective happiness as assessed by four-item Subjective Happiness Scale</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Family harmony as assessed by Generic Family Harmony Scale</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knowledge of Hong Kong as assessed by 20 self-developed questions</measure>
    <time_frame>1 month</time_frame>
    <description>Examples of items are &quot;free education is available for nine years in Hong Kong&quot; and &quot;Persons who have immigrated to Hong Kong less than seven years ago are not eligible to apply for public housing&quot;</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">353</enrollment>
  <condition>Parenting</condition>
  <arm_group>
    <arm_group_label>Parenting</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>To receive the parenting intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Information</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>To receive the information intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Parenting</intervention_name>
    <description>The parenting intervention consists of four weekly sessions, each lasting two hours. The intervention was designed according to the parenting characteristics of Chinese parents in Hong Kong. The four sessions cover: 1) response modification (&quot;stop and rest&quot;), 2) relaxation/enhancing positive moods (&quot;relax and play&quot;), 3) cognitive reframing (&quot;think&quot;), and 4) using social support (&quot;talk and share). Discussion, practice, and questions are involved in each session.</description>
    <arm_group_label>Parenting</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Information</intervention_name>
    <description>The information intervention consists of four weekly sessions, each lasting for two hours. The contents cover information and resources about education, medical care, housing, employment, and community facilities available in Hong Kong and Mainland China.</description>
    <arm_group_label>Information</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The parents of cross-boundary and new arrival children whose children born or moved to&#xD;
             Hong Kong with the one-way exit permits.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#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>Nancy Xiaonan Yu</last_name>
    <role>Principal Investigator</role>
    <affiliation>City University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>City University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>January 24, 2018</last_update_submitted>
  <last_update_submitted_qc>January 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>City University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Nancy Xiaonan Yu</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>emotion management</keyword>
  <keyword>positive and negative affect</keyword>
  <keyword>satisfaction with parent-child relationship</keyword>
  <keyword>subjective happiness</keyword>
  <keyword>family harmony</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02986009
org study id: FC2016
nct id: NCT02986009
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The collaborator has its vision as "To have children, individuals, families and migrants
      across countries live in dignity and harmony, and be contributing members to a just, humane
      and caring society." Parents are very significant in the families as they need nurturing,
      discipline, teaching, monitoring, and managing their children as well as their families.
      Capable and competent parents bring good child outcome and happy family. The investigators
      planned to serve targeted parents in two areas as 1. Emotion management and 2. Information on
      community resource. In the first set, the participants are expected to improve their emotion
      management leading to a more effective parenting. In the second set, the participants would
      acquire more information that enables them to better use the community resources.

      To work closely with the collaborator, and based on the previous results of an effective
      parenting intervention, the investigators will modify the intervention to tailor the needs of
      targeted parents. The objectives are:

        1. After completing the parenting intervention, 150 participants will, 1.1. To increase
           participants' emotion management strategies by 20%, 1.2. To enhance positive affect by
           10%, 1.3. To decrease negative affect by 10%, 1.4. To enhance satisfaction with the
           parent-child relationship by 10%, 1.5. To increase subjective happiness by 8%, 1.6. To
           enhance family harmony by 5%, These levels of positive effects of the program were
           projected from the investigators' published findings.

        2. After joining the information sessions about education, health care, housing,
           employment, and community facilities, another 150 participants will, 2.1 To know more
           information of Hong Kong by 50%, 2.2 To know more information of Mainland China by 50%,
           2.3 To use more community resources either in Hong Kong or Mainland China by 50%.

      To study the effectiveness of parenting intervention, the investigators proposed to use a
      randomized controlled trial (RCT) that is a type of scientific study to reduce bias.
      Participants in this project will be randomly allocated to either the emotional management
      group or the information group. As the information group has no focus on parenting,
      participants would show no significant improvement in emotion management strategies or
      satisfaction with the parent-child relationship, etc. Meanwhile, participants in the
      parenting intervention would show no significant improvement in knowledge about either Hong
      Kong or Mainland China.
Parenting not only acts as an important drive for child development, also serves as one of
      the key determinants for family relationships. Emotion management is the essence of parenting
      competence. Anger, fear, joy, distress and enthusiasm are involved in the parenting process.
      Negative emotions of parents are associated with child abuse; while positive emotions are
      related to warm parenting, and promote children's early attachment with parents. In addition,
      parental negative emotion consistently predicts behavior problems of children. For example,
      children who are exposed to higher levels of maternal negative feelings, such as anger, have
      more difficulty regulating their own negative feelings and have greater difficulty getting
      along with others.

      Emotion management training has been shown effective in improving parenting skills, promoting
      parent-child interaction, and preventing child abuse. For example, parents who attended anger
      control workshops reported less unrealistic expectations for their children, fewer conflicts
      with children, and less domestic violence toward spouse and children. However, these
      interventions were tested in Western culture where there is much less emphasis on academic
      performance of children. In addition, such interventions usually contain complex content and
      last for months.

      The investigators developed a parenting intervention tailored for Chinese parents and
      reported its effectiveness in a randomized controlled trial. In this empirical study, 412
      Hong Kong mothers of children aged 6 to 8 years old were randomized into the parenting arm or
      the control arm. The results showed that the parenting arm reported greater increase in the
      use of emotion management found that it was effective in increasing emotion management skills
      and enhancing the parent-child relationship. Participants in the parenting arm also reported
      lower negative affect, and higher positive affect, satisfaction with the parent-child
      relationship, and family harmony, compared to the control arm. The investigators' findings
      provide evidence for a sustainable, preventive, culturally appropriate, and cognitive
      behavioral-based parenting program in the community population. Considering unique dynamics
      of cross-boundary and new arrival families, a short and simple intervention on emotion
      management would benefit these parents to perform better parenting. Therefore based on the
      investigators' promising findings in the community setting, this proposed program aim to
      modify this parenting program to the needs of parents of the cross-boundary and new arrival
      children.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Frequency of emotion management strategies as assessed by 10 self-developed items
time frame: 1 month
description: Example items include "stop thinking about the situation and do something else", "relax to calm down", "think of the reasons for child's behavior", "talk to family or friends", and "manage anger when child misbehaves"
measure: Positive and negative affect as assessed by 10 items from the Positive and Negative Affect Schedule
time frame: 1 month
measure: Satisfaction with parent-child relationship as assessed by a single item from the Kansas Marital Satisfaction Scale
time frame: 1 month
measure: Subjective happiness as assessed by four-item Subjective Happiness Scale
time frame: 1 month
measure: Family harmony as assessed by Generic Family Harmony Scale
time frame: 1 month
measure: Knowledge of Hong Kong as assessed by 20 self-developed questions
time frame: 1 month
description: Examples of items are "free education is available for nine years in Hong Kong" and "Persons who have immigrated to Hong Kong less than seven years ago are not eligible to apply for public housing"
arm group label: Parenting
arm group type: Experimental
description: To receive the parenting intervention
arm group label: Information
arm group type: Experimental
description: To receive the information intervention
intervention type: Behavioral
intervention name: Parenting
description: The parenting intervention consists of four weekly sessions, each lasting two hours. The intervention was designed according to the parenting characteristics of Chinese parents in Hong Kong. The four sessions cover: 1) response modification ("stop and rest"), 2) relaxation/enhancing positive moods ("relax and play"), 3) cognitive reframing ("think"), and 4) using social support ("talk and share). Discussion, practice, and questions are involved in each session.
arm group label: Parenting
intervention type: Behavioral
intervention name: Information
description: The information intervention consists of four weekly sessions, each lasting for two hours. The contents cover information and resources about education, medical care, housing, employment, and community facilities available in Hong Kong and Mainland China.
arm group label: Information
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Nancy Xiaonan Yu
role: Principal Investigator
affiliation: City University of Hong Kong
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: City University of Hong Kong
investigator full name: Nancy Xiaonan Yu
investigator title: Assistant Professor
sharing ipd: No