NCT02986022

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
241

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 7, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

December 7, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
Last Updated

July 18, 2018

Status Verified

July 1, 2018

Enrollment Period

1.2 years

First QC Date

November 29, 2016

Last Update Submit

July 16, 2018

Conditions

Keywords

Self-efficacyoptimismaltruismgoal setting

Outcome Measures

Primary Outcomes (1)

  • Resilience as assessed by Connor-Davidson Resilience Scale

    1 month

Secondary Outcomes (3)

  • Depressive symptoms as assessed by Patient-Health Questionnaire-9

    1 month

  • Adaptation difficulties as assessed by Sociocultural Adaptation Scale

    1 month

  • Knowledge measured using the items developed in our previous study

    1 month

Study Arms (2)

Resilience

EXPERIMENTAL

Participants will receive four sessions covering Resilience intervention content

Behavioral: Resilience

Resilience+Information

ACTIVE COMPARATOR

Participants will receive four sessions covering Resilience intervention and Information intervention contents.

Behavioral: ResilienceBehavioral: Information

Interventions

ResilienceBEHAVIORAL

Self-efficacy, optimism, altruism, goal setting

ResilienceResilience+Information
InformationBEHAVIORAL

Information and resources about education, medical care, housing, employment, and community facilities available in Hong Kong and Mainland China

Resilience+Information

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Immigrants who arrived in Hong Kong from Mainland China less than 3 years ago
  • have least a primary school education

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City University of Hong Kong

Hong Kong, China

Location

MeSH Terms

Conditions

Altruism

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Nancy Xiaonan Yu

    City University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 29, 2016

First Posted

December 7, 2016

Study Start

December 7, 2016

Primary Completion

February 8, 2018

Study Completion

March 31, 2018

Last Updated

July 18, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations