ResilienceNCT02986022
A Psychological Intervention to Enhance Resilience in Mainland New Immigrants to Hong Kong
A study testing Resilience and Information in people with Resilience, run by City University of Hong Kong at 1 site in China.
Trial summary
Background: Resilience is important for successful adaptation. The investigators' resilience intervention was effective in enhancing resilience, emotional functioning, and adaptation in Mainland immigrants. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Resilience
- What is being tested?
- Resilience and Information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 1 siteChina
- Study dates
- 7 Dec 2016to 31 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Immigrants who arrived in Hong Kong from Mainland China less than 3 years ago
- have least a primary school education
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
Objectives:
- We will conduct a randomized controlled trial to compare the resilience intervention with the resilience + information intervention (a compound module) among 200 new immigrants,
- 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,
- 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
- 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.
Read the detailed description
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).
- Conditions
- Resilience
- Being tested
- Resilience, Information
- Keywords
- Self-efficacy, optimism, altruism, goal setting
- Medical subject headings
- Altruism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResilienceBehavioural
Self-efficacy, optimism, altruism, goal setting
InformationBehavioural
Information and resources about education, medical care, housing, employment, and community facilities available in Hong Kong and Mainland China
| Study group | Role | What they receive |
|---|---|---|
| Resilience | Experimental | Participants will receive four sessions covering Resilience intervention content Receives: Behavioral: Resilience |
| Resilience+Information | Active comparator | Participants will receive four sessions covering Resilience intervention and Information intervention contents. Receives: Behavioral: Resilience; Behavioral: Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resilience as assessed by Connor-Davidson Resilience Scale
Measured: 1 month
Secondary outcomes (3)
Depressive symptoms as assessed by Patient-Health Questionnaire-9
Measured: 1 month
Adaptation difficulties as assessed by Sociocultural Adaptation Scale
Measured: 1 month
Knowledge measured using the items developed in our previous study
Knowledge on services and resources regarding transportation, housing, medical service, education, and employment
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study start7 Dec 2016
- Primary completion8 Feb 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ResilienceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- City University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- International Social Service Hong Kong Branch
- Responsible party
- Principal investigator, Nancy Xiaonan Yu, City University of Hong Kong
- Investigators
- Nancy Xiaonan Yu, Principal investigator, City University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02986022
- Sponsor's protocol ID
- HCPF2016
- Status last verified
- Jul 2018
- First submitted
- 29 Nov 2016
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Psychological Intervention to Enhance Resilience in Mainland New Immigrants to Hong Kong
- ClinicalTrials.gov ID
- NCT02986022
- Acronym / sponsor ID
- HCPF2016
- Conditions
- Resilience
- Keywords
- Self-efficacy, optimism, altruism, goal setting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- City University of Hong KongUniversity, hospital or other
- Collaborators
- International Social Service Hong Kong Branch
- Study start
- 7 Dec 2016 (actual)
- Primary completion
- 8 Feb 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 7 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- We will conduct a randomized controlled trial to compare the resilience intervention with the resilience + information intervention (a compound module) among 200 new immigrants,
- 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,
- 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
- 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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resilience | Experimental | Behavioral: ResilienceParticipants will receive four sessions covering Resilience intervention content |
| Resilience+Information | Active comparator | Behavioral: Resilience, Behavioral: InformationParticipants will receive four sessions covering Resilience intervention and Information intervention contents. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Immigrants who arrived in Hong Kong from Mainland China less than 3 years ago
- have least a primary school education
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ResilienceSelf-efficacy, optimism, altruism, goal setting | Behavioural | Resilience, Resilience+Information |
| InformationInformation and resources about education, medical care, housing, employment, and community facilities available in Hong Kong and Mainland China | Behavioural | Resilience+Information |
Primary outcome
Resilience as assessed by Connor-Davidson Resilience Scale
Time frame: 1 month
3 secondary outcomes
Depressive symptoms as assessed by Patient-Health Questionnaire-9
Time frame: 1 month
Adaptation difficulties as assessed by Sociocultural Adaptation Scale
Time frame: 1 month
Knowledge measured using the items developed in our previous study
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy Xiaonan Yu principal investigator
City University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resilience and Information in people with Resilience, run by City University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resilience as assessed by Connor-Davidson Resilience Scale (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2018.