<clinical_study>
  <!-- This xml conforms to an XML Schema at:
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  <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/NCT02986022</url>
  </required_header>
  <id_info>
    <org_study_id>HCPF2016</org_study_id>
    <nct_id>NCT02986022</nct_id>
  </id_info>
  <brief_title>A Psychological Intervention to Enhance Resilience in Mainland New Immigrants to Hong Kong</brief_title>
  <official_title>A Psychological Intervention to Enhance Resilience in Mainland New Immigrants to Hong Kong</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      Resilience is important for successful adaptation. The investigators' resilience intervention&#xD;
      was effective in enhancing resilience, emotional functioning, and adaptation in Mainland&#xD;
      immigrants. In the present proposal, the investigators will work with the International&#xD;
      Social Service to scale up application of this intervention in immigrants, and develop the&#xD;
      training infrastructure to ensure that the evidence-based intervention can be sustained&#xD;
      despite turnover of interventionists.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
        1. We will conduct a randomized controlled trial to compare the resilience intervention&#xD;
           with the resilience + information intervention (a compound module) among 200 new&#xD;
           immigrants,&#xD;
&#xD;
        2. The resilience intervention will enhance participants' resilience by 5%, and decrease&#xD;
           their depressive symptoms by 20% and adaptation difficulties by 10% after the completion&#xD;
           of the intervention,&#xD;
&#xD;
        3. The resilience + information intervention will have higher increases in resilience and&#xD;
           more decreases in depressive symptoms and adaptation difficulties compared to the&#xD;
           resilience intervention, and&#xD;
&#xD;
        4. To establish a sustaining mechanism which ensures that these two interventions can&#xD;
           continue to be used in routine services.&#xD;
&#xD;
      Project design:&#xD;
&#xD;
      Well-trained social workers will deliver the intervention. Participants will complete&#xD;
      programme evaluation. A train-the-trainer workshop and training materials will be prepared to&#xD;
      transfer knowledge to social workers who are future trainers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The intervention programme has been developed, manualized, and rigorously tested in our&#xD;
      previous study (1). This programme is largely a replica of our original programme. Two social&#xD;
      workers will deliver the resilience intervention. One of the two interventionists who&#xD;
      delivered the intervention in our empirical study is still available. One more social worker&#xD;
      will be selected from recently trained interventionists to deliver this intervention.&#xD;
&#xD;
      This resilience intervention (see Supplement 2) consists of 4 sessions, each lasting for 2&#xD;
      hours, finished within two weeks. This intervention is built on the international and local&#xD;
      evidence about positive characteristics that promote successful immigration and effective&#xD;
      strategies that enhance psychological well-being.&#xD;
&#xD;
      We will promote this intervention programme in new immigrants, and recruit participants by&#xD;
      open recruitment, contacting current service users of the community agency, referral and cold&#xD;
      call. Orientation gatherings will be organized to screen for eligible immigrants.&#xD;
&#xD;
      The resilience + information intervention consists of 4 sessions, each lasting for 2.5 hours,&#xD;
      finished within two weeks. In each session, the resilience section will last for 2 hours&#xD;
      (identical to the resilience intervention), and the information intervention will be half an&#xD;
      hour. Similar to our previous information intervention, this information section will cover&#xD;
      transportation, housing, medical service, education, and employment, the important&#xD;
      information helpful for the immigrants' adaptation.&#xD;
&#xD;
      Participants will receive four sessions, either the resilience intervention or the resilience&#xD;
      + information intervention. Unlike most programmes that have not been developed in the&#xD;
      community, we have identified some key strategies to reduce attrition during the&#xD;
      intervention. Before each session, social workers will call participants to remind them of&#xD;
      the coming session. During the intervention, we will provide child care upon participants'&#xD;
      request. For those who are unable to attend a specific sessions, social workers will conduct&#xD;
      a make-up on the content, and provide general encouragement that attendance of further&#xD;
      sessions will bring important gains. During the follow-up period, social workers will send&#xD;
      reminder postcards to participants. At the end of the intervention, participants will obtain&#xD;
      a certificate in recognition of their participation in this programme. Evaluation will be&#xD;
      conducted before the first session (pre-intervention) and immediately after the intervention&#xD;
      (post-intervention).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 7, 2016</start_date>
  <completion_date type="Actual">March 31, 2018</completion_date>
  <primary_completion_date type="Actual">February 8, 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Resilience as assessed by Connor-Davidson Resilience Scale</measure>
    <time_frame>1 month</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Depressive symptoms as assessed by Patient-Health Questionnaire-9</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adaptation difficulties as assessed by Sociocultural Adaptation Scale</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knowledge measured using the items developed in our previous study</measure>
    <time_frame>1 month</time_frame>
    <description>Knowledge on services and resources regarding transportation, housing, medical service, education, and employment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">241</enrollment>
  <condition>Resilience</condition>
  <arm_group>
    <arm_group_label>Resilience</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive four sessions covering Resilience intervention content</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Resilience+Information</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive four sessions covering Resilience intervention and Information intervention contents.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Resilience</intervention_name>
    <description>Self-efficacy, optimism, altruism, goal setting</description>
    <arm_group_label>Resilience</arm_group_label>
    <arm_group_label>Resilience+Information</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Information</intervention_name>
    <description>Information and resources about education, medical care, housing, employment, and community facilities available in Hong Kong and Mainland China</description>
    <arm_group_label>Resilience+Information</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Immigrants who arrived in Hong Kong from Mainland China less than 3 years ago&#xD;
&#xD;
          -  have least a primary school education&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  N/A&#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>July 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>July 16, 2018</last_update_submitted>
  <last_update_submitted_qc>July 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 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>Self-efficacy</keyword>
  <keyword>optimism</keyword>
  <keyword>altruism</keyword>
  <keyword>goal setting</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/NCT02986022
org study id: HCPF2016
nct id: NCT02986022
lead sponsor: 
collaborator: 
has dmc: No
Background:

      Resilience is important for successful adaptation. The investigators' resilience intervention
      was effective in enhancing resilience, emotional functioning, and adaptation in Mainland
      immigrants. In the present proposal, the investigators will work with the International
      Social Service to scale up application of this intervention in immigrants, and develop the
      training infrastructure to ensure that the evidence-based intervention can be sustained
      despite turnover of interventionists.

      Objectives:

        1. We will conduct a randomized controlled trial to compare the resilience intervention
           with the resilience + information intervention (a compound module) among 200 new
           immigrants,

        2. The resilience intervention will enhance participants' resilience by 5%, and decrease
           their depressive symptoms by 20% and adaptation difficulties by 10% after the completion
           of the intervention,

        3. The resilience + information intervention will have higher increases in resilience and
           more decreases in depressive symptoms and adaptation difficulties compared to the
           resilience intervention, and

        4. To establish a sustaining mechanism which ensures that these two interventions can
           continue to be used in routine services.

      Project design:

      Well-trained social workers will deliver the intervention. Participants will complete
      programme evaluation. A train-the-trainer workshop and training materials will be prepared to
      transfer knowledge to social workers who are future trainers.
The intervention programme has been developed, manualized, and rigorously tested in our
      previous study (1). This programme is largely a replica of our original programme. Two social
      workers will deliver the resilience intervention. One of the two interventionists who
      delivered the intervention in our empirical study is still available. One more social worker
      will be selected from recently trained interventionists to deliver this intervention.

      This resilience intervention (see Supplement 2) consists of 4 sessions, each lasting for 2
      hours, finished within two weeks. This intervention is built on the international and local
      evidence about positive characteristics that promote successful immigration and effective
      strategies that enhance psychological well-being.

      We will promote this intervention programme in new immigrants, and recruit participants by
      open recruitment, contacting current service users of the community agency, referral and cold
      call. Orientation gatherings will be organized to screen for eligible immigrants.

      The resilience + information intervention consists of 4 sessions, each lasting for 2.5 hours,
      finished within two weeks. In each session, the resilience section will last for 2 hours
      (identical to the resilience intervention), and the information intervention will be half an
      hour. Similar to our previous information intervention, this information section will cover
      transportation, housing, medical service, education, and employment, the important
      information helpful for the immigrants' adaptation.

      Participants will receive four sessions, either the resilience intervention or the resilience
      + information intervention. Unlike most programmes that have not been developed in the
      community, we have identified some key strategies to reduce attrition during the
      intervention. Before each session, social workers will call participants to remind them of
      the coming session. During the intervention, we will provide child care upon participants'
      request. For those who are unable to attend a specific sessions, social workers will conduct
      a make-up on the content, and provide general encouragement that attendance of further
      sessions will bring important gains. During the follow-up period, social workers will send
      reminder postcards to participants. At the end of the intervention, participants will obtain
      a certificate in recognition of their participation in this programme. Evaluation will be
      conducted before the first session (pre-intervention) and immediately after the intervention
      (post-intervention).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Resilience as assessed by Connor-Davidson Resilience Scale
time frame: 1 month
measure: Depressive symptoms as assessed by Patient-Health Questionnaire-9
time frame: 1 month
measure: Adaptation difficulties as assessed by Sociocultural Adaptation Scale
time frame: 1 month
measure: Knowledge measured using the items developed in our previous study
time frame: 1 month
description: Knowledge on services and resources regarding transportation, housing, medical service, education, and employment
arm group label: Resilience
arm group type: Experimental
description: Participants will receive four sessions covering Resilience intervention content
arm group label: Resilience+Information
arm group type: Active Comparator
description: Participants will receive four sessions covering Resilience intervention and Information intervention contents.
intervention type: Behavioral
intervention name: Resilience
description: Self-efficacy, optimism, altruism, goal setting
arm group label: Resilience
arm group label: Resilience+Information
intervention type: Behavioral
intervention name: Information
description: Information and resources about education, medical care, housing, employment, and community facilities available in Hong Kong and Mainland China
arm group label: Resilience+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