NCT02096432

Brief Summary

This project aims to develop and refine a suicide intervention protocol, and pilot test a culturally tailored randomized control trial to reduce suicidal thoughts among U.S. Chinese older adults. During the first phase of the study, the investigators plan to invite the community advisory board and key stakeholders to participate in the iterative design and refinement of the study protocol. During the second phase of the project and after the initial screening and based on a specific set of inclusion criteria, the investigators will invite U.S. Chinese older adult to participate in a pilot randomized control trial of a culturally adapted intervention to reduce the frequency and intensity of suicidal thoughts in Chinese older adults. During the third phase of the project, the investigators plan to invite pilot intervention participants as well as key stakeholders and health care professionals on the cultural acceptability of the pilot intervention. Through the achievement of these objectives, the investigators will set the foundation to fully test a culturally adapted in-home intervention, which may be particularly suitable for Chinese older adults with suicidal thoughts as it addresses cultural-specific barriers and integrates care management within existing community services agencies using non-mental health professionals, including community health workers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable

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

March 19, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 26, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

December 21, 2022

Status Verified

December 1, 2022

Enrollment Period

3.8 years

First QC Date

March 19, 2014

Last Update Submit

December 20, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patient Health Questionnaire-9 (PHQ-9)

    Outcome measure will be measured in 10 weeks' time

Study Arms (2)

Behavioral: Behavioral Activation

EXPERIMENTAL

Behavioral Activation includes the following components: empowering education, referral to treatment, care Management, and behavior activation

Behavioral: Behavior Activation

Usual Community Care

OTHER

Community standard care as usual

Behavioral: Usual Community Care

Interventions

Behavioral Activation includes the following components: empowering education, referral to treatment, care Management, and behavior activation

Behavioral: Behavioral Activation

Community standard care as usual

Usual Community Care

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Self-identified as Chinese
  • \>50 years of age
  • Suicidal thoughts within the last month as detected from the Item 9 in PHQ-9
  • No plans to move for 6 months
  • No significant cognitive impairment with Chinese Mini-Mental State Examination (C-MMSE) score \>20

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese community

Chicago, Illinois, 60616, United States

Location

MeSH Terms

Conditions

Suicidal Ideation

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • XinQi Dong, MD, MPH

    Rush University Medical Center

    PRINCIPAL INVESTIGATOR
  • Melissa A. Simon, MD, MPH

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2014

First Posted

March 26, 2014

Study Start

October 1, 2014

Primary Completion

July 1, 2018

Study Completion

November 1, 2018

Last Updated

December 21, 2022

Record last verified: 2022-12

Locations