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Group Interventions for Suicidal African Americans

Primary Purpose

Depression, Mental Illness, Suicide

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
10 weekly group meetings
Outpatient counseling and support groups
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 - 64 yrs old
  • patients who seek treatment at Grady Health System (GHS) after a suicide attempt
  • African American
  • speak English

Exclusion Criteria:

  • cognitive impairments
  • medical instability

Sites / Locations

  • Grady Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Psychosocial group intervention

Control

Arm Description

Subjects will seek outpatient counseling, support groups, in addition to 10 weekly group meetings

Subjects will seek outpatient counseling and support groups only

Outcomes

Primary Outcome Measures

Change in scores on Beck Scale for Suicidal Ideation
Beck Scale for Suicidal Ideation is a 21-item instrumentation used to measure the current intensity of patients' specific attitudes, behaviors and plans to commit suicide.

Secondary Outcome Measures

Change in scores on Beck Depression Inventory - II
Beck Depression Inventory - II is a 21-item, self-reported questionnaire used to assess characteristics of depression.
Change in scores on Beck Hopelessness Scale
Beck Hopelessness Scale is a 20-item true-false self-report scale that measures the level of negative expectations about the future held by respondents
Change in scores on WHO Quality of Life Brief Instrument
The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment.
Patient Satisfaction
Intervention Satisfaction Survey (ISS)

Full Information

First Posted
August 26, 2014
Last Updated
December 13, 2017
Sponsor
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT02227160
Brief Title
Group Interventions for Suicidal African Americans
Official Title
Group Interventions for Suicidal African Americans
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Withdrawn
Why Stopped
This study never started enrolling participants due to lack of grant funding.
Study Start Date
May 2016 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigator is conducting a hybrid efficacy-effectiveness randomized controlled trial with low-income African American suicide attempters. Guided by the Theory of Triadic Influence (TTI), this pilot randomized controlled trial aims: to determine if psychosocial group intervention (PGI) is more effective than enhanced treatment as usual (ETAU) in reducing suicidal behavior (ideation, attempts; primary outcome) and improving its correlates (depressive symptoms, hopelessness, quality of life) (secondary outcomes) in low-income African Americans with a recent attempt. to determine if PGI is more effective than ETAU at bolstering intrapersonal (I), social/situational (SS), and cultural/environmental (CE) risk and protective factors that mediate the condition-suicidal behavior and correlates link and thus serve as mechanisms of change. to determine I, SS, and CE variables that moderate the condition-suicidal behavior link and thus serve as predictors of intervention outcome. Hypothesis for Aim 1: At post-intervention and follow-up, PGI participants will evidence greater improvements in suicidal behavior and its correlates than those in ETAU. Hypothesis for Aim 2: Changes in these risk and protective factors will account for condition effects on outcomes: (1) psychological distress, aggression, impulsivity, substance abuse, low self-esteem, and suicide acceptability (I-risk); (2) perceived burdensomeness and thwarted belongingness, relationship discord, intimate partner violence perpetration and victimization (SS-risk); (3) access to a weapon and barriers to service utilization (CE-risk); (4) reasons for living, optimism, positive ethnic identity, effective coping, and spiritual well-being (I-protective); (5) overall family health and social support from family and friends (SS-protective); and (6) religious involvement and effectiveness of obtaining resources (CE-protective). Hypothesis for Aim 3: Individuals (1) having fewer Diagnostic and Statistical Manual of Mental Disorders (DSM) disorders and attachment styles characterized by positivity toward the self and others (I); (2) children and more limited trauma histories (SS); and (3) more daily hassles and less exposure to community disorder (CE) will evidence greater reductions in suicidal behavior and its correlates and greater enhancements in quality of life at post-intervention and follow-up.
Detailed Description
Attention will be paid to Theory of Triadic Influence intrapersonal, social/ situational, and cultural/ environmental risk and protective factors that impact outcomes. The central hypothesis is that compared to enhanced treatment as usual, through targeting Theory of Triadic Influence-risk and protective factors the culturally-informed, Theory of Triadic Influence-driven, empowerment based psychosocial group intervention will more positively alter trajectories in suicidal behaviors and its correlates. The rationale is that upon study completion, if data support the psychosocial group intervention value, they will facilitate our long-term goal of disseminating evidence-based culturally-relevant interventions. In order to test the hypothesis that at post-intervention and 6 and 12-month follow-up, compared to individuals in ETAU, those in the PGI will endorse less I, SS, and CE risk factors, reduced suicidal ideation, depressive symptoms, and hopelessness, and greater levels of I, SS, and CE protective factors as well as increased quality of life, the study procedures will be as follows: Male and female participants between the ages of 18-64 will be recruited in the medical and psychiatric emergency rooms at GHS. Once the individual has been medically cleared and has provided informed consent, he/she will be screened for study appropriateness by trained project team members (10-20 minutes). If he/she meets inclusion criteria, study participation will include a 3-hour interview. All study measures will be read to each participant. Measures will assess background variables, suicidal behavior, depressive symptoms, hopelessness, quality of life, and I, SS, and CE risk and protective factors. All measures are psychometrically sound and appropriate for use with an African American population. Once the interview is over, the participant will be randomly assigned to either the PGI (10 group therapy sessions) or the ETAU condition (participation in a support group focused on suicidal behaviors plus suicidal behavior monitoring and help with accessing resources). The PGI, conducted in accord with the culturally informed, TTI-guided, and empowerment based group protocol, and the support group will be unstructured; both groups will last 120 minutes. Following the completion of the PGI or ETAU condition, the individuals will be assessed at post-intervention (3 hours), and at 6 month and 12 month follow-ups (3 hours each). To increase retention and reduce suicide risk, reminder phone calls will be made and texts sent on Relieflink, a suicide prevention app that received 1st prize in an App Challenge sponsored by Substance Abuse and Mental Health Services Administration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Mental Illness, Suicide, Suicidal Ideation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Psychosocial group intervention
Arm Type
Experimental
Arm Description
Subjects will seek outpatient counseling, support groups, in addition to 10 weekly group meetings
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Subjects will seek outpatient counseling and support groups only
Intervention Type
Behavioral
Intervention Name(s)
10 weekly group meetings
Intervention Description
10 weekly group meetings with up to five other men and women at Grady Health System
Intervention Type
Behavioral
Intervention Name(s)
Outpatient counseling and support groups
Intervention Description
Usual mental health care
Primary Outcome Measure Information:
Title
Change in scores on Beck Scale for Suicidal Ideation
Description
Beck Scale for Suicidal Ideation is a 21-item instrumentation used to measure the current intensity of patients' specific attitudes, behaviors and plans to commit suicide.
Time Frame
Baseline, post-therapy, 6 months and 12 months after therapy
Secondary Outcome Measure Information:
Title
Change in scores on Beck Depression Inventory - II
Description
Beck Depression Inventory - II is a 21-item, self-reported questionnaire used to assess characteristics of depression.
Time Frame
Baseline, post-therapy, 6 months and 12 months after therapy
Title
Change in scores on Beck Hopelessness Scale
Description
Beck Hopelessness Scale is a 20-item true-false self-report scale that measures the level of negative expectations about the future held by respondents
Time Frame
Baseline, post-therapy, 6 months and 12 months after therapy
Title
Change in scores on WHO Quality of Life Brief Instrument
Description
The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment.
Time Frame
Baseline, post-therapy, 6 months and 12 months after therapy
Title
Patient Satisfaction
Description
Intervention Satisfaction Survey (ISS)
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Change in the Symptom Checklist 90-Revised (SCL 90-R) scale
Description
Symptom Checklist 90-Revised (SCL 90-R) questionnaire measures overall levels of psychological and physical functioning.
Time Frame
Baseline, post-therapy, 6 months and 12 months after therapy
Title
Change in scores for Alcohol Use Disorders Identification Test
Description
Alcohol Use Disorders Identification Test (AUDIT) is a 10 question test to determine if a person's alcohol consumption may be harmful
Time Frame
Baseline, post-therapy, 6 months and 12 months after therapy
Title
Change in scores on Drug Abuse Screening Test
Description
Drug Abuse Screening Test (DAST) is a 28-item self-report scale that is used as a screening instrument for the abuse of drugs other than alcohol.
Time Frame
Baseline, post-therapy, 6 months and 12 months after therapy
Title
Change in scores on Rosenberg Self-Esteem Scale (RSE)
Description
A 10-item scale that measures global self-worth by measuring both positive and negative feelings about the self.
Time Frame
Baseline, post-therapy, 6 months and 12 months after therapy
Title
Changes in scores on Short Form Buss-Perry Aggression Questionnaire
Description
Short Form Buss-Perry Aggression Questionnaire is a 12-item short form that assesses four aspects of aggressive behavior: physical aggression, verbal aggression, anger and hostility.
Time Frame
Baseline, post-therapy, 6 months and 12 months after therapy
Title
Changes in scores on Barratt Impulsiveness Scale
Description
Barratt Impulsiveness Scale is a 30-item self-report questionnaire designed to assess general impulsiveness taking into account the multifactorial nature of the construct.
Time Frame
Baseline, post-therapy, 6 months and 12 months after therapy
Title
Change in scores on Suicide Acceptability Scale
Description
Suicide Acceptability Scale is an 8-item measure of suicide acceptability
Time Frame
Baseline, post-therapy, 6 months and 12 months after therapy
Title
Changes in scores on Interpersonal Needs Questionnaire (INQ)
Description
Interpersonal Needs Questionnaire (INQ) is a 15-item self-report measure of the constructs of thwarted belongingness and perceived burdensomeness as defined by the Interpersonal Theory of Suicide.
Time Frame
Baseline, post-therapy, 6 months and 12 months after therapy
Title
Change in scores on Dyadic Adjustment Scale
Description
Dyadic Adjustment Scale is a 32-item self-report tool used to assess couple satisfaction and to evaluate how each partner within the couple perceives his or her relationship
Time Frame
Baseline, post-therapy, 6 months and 12 months after therapy
Title
Change in scores on Conflict Tactics Scale-Revised
Description
Conflict Tactics Scale-Revised (CTS-2) is 78-item, self-administered questionnaire that assesses both positive and negative behaviors used in response to conflict between romantic partners in the past year
Time Frame
Baseline, post-therapy, 6 months and 12 months after therapy
Title
Clinical Demographic Questionnaire
Description
Demographic questionnaire assesses demographic information as well as information regarding to access to weapons
Time Frame
Baseline
Title
Change in scores on Reasons for Living Inventory
Description
Reasons for Living Inventory contains 12 possible reasons for living, which respondents rate regarding the importance each item would be for living if suicide were contemplated.
Time Frame
Baseline, post-therapy, 6 months and 12 months after therapy
Title
Change in scores on Life Orientation Test - Revised
Description
Life Orientation Test - Revised is a 10-item test assessing generalized positive outcome expectancies
Time Frame
Baseline, post-therapy, 6 months and 12 months after therapy
Title
Change in scores on Multi-dimensional Inventory of Black Identity
Description
The Multi-dimensional Inventory of Black Identity is designed to assess the three cross-situationally stable dimensions (Centrality, Regard, and Ideology)
Time Frame
Baseline, post-therapy, 6 months and 12 months after therapy
Title
Change in scores on Ways of Coping (Revised) Questionnaire
Description
Ways of Coping (Revised) is self-reported questionnaire used to assess adaptive and maladaptive ways to cope with negative emotions or problematic situations
Time Frame
Baseline, post-therapy, 6 months and 12 months after therapy
Title
Change in scores on Africultural Coping Systems Inventory
Description
Africultural Coping Systems Inventory is a 30-item measure of the culture-specific coping strategies used by African Americans in stressful situations and is grounded in an African-centered conceptual framework
Time Frame
Baseline, post-therapy, 6 months and 12 months after therapy
Title
Change in scores on Barriers to Accessing Services Scale
Time Frame
Baseline, post-therapy, 6 months and 12 months after therapy
Title
Change in scores on Spiritual Well-Being Scale
Description
Spiritual Well-Being Scale is a 20-item scale used for the assessment of both individual and congregational spiritual well-being
Time Frame
Baseline, post-therapy, 6 months and 12 months after therapy
Title
Change in scores on Family Assessment Device
Description
Family Assessment Device is a 53 item questionnaire designed to evaluate families.
Time Frame
Baseline, post-therapy, 6 months and 12 months after therapy
Title
Change in scores on Social Support Behaviors Scale
Description
Social Support Behaviors Scale is designed to assess supportive behavior available from family and from friends.
Time Frame
Baseline, post-therapy, 6 months and 12 months after therapy
Title
Changes in scores on Multidimensional Measure of Religious Involvement for African Americans
Description
Multidimensional Measure of Religious Involvement for African Americans is a 12-item scale measuring religious indicators.
Time Frame
Baseline, post-therapy, 6 months and 12 months after therapy
Title
Change in score on Effectiveness of Obtaining Resources questionnaire
Time Frame
Baseline, post-therapy, 6 months and 12 months after therapy
Title
Change in evaluation on Structured Clinical Interview for DSM-5-Research Version
Description
Structured Clinical Interview for DSM-5-Research Version is semi-structured interview that allows researchers to make clinical diagnoses according to DSM criteria
Time Frame
Baseline, post-therapy, 6 months and 12 months after therapy
Title
Change in evaluation on Structured Clinical Interview for DSM-PD
Description
The Structured Clinical Interview for DSM-PD is a semi-structured interview for making DSM-IV Axis II: Personality Disorder diagnoses
Time Frame
Baseline, post-therapy, 6 months and 12 months after therapy
Title
Change in scores on Relationship Scales Questionnaire
Description
Relationship Scales Questionnaire is a scale that consists of 17 items to assess attachment patterns.
Time Frame
Baseline, post-therapy, 6 months and 12 months after therapy
Title
Change in scores on Childhood Trauma Questionnaire - Short Form (CTQ-SF)
Description
The CTQ-SF is a 28-item self-report instrument for adults and adolescents that assesses retrospective child abuse and neglect
Time Frame
Baseline, post-therapy, 6 months and 12 months after therapy
Title
Change in scores on Survey of Recent Life Experiences scale
Description
Survey of Recent Life Experiences is a 51-item self-report instrument that measures hassles for adults
Time Frame
Baseline, post-therapy, 6 months and 12 months after therapy
Title
Change in scores on Community Disorder Scale
Time Frame
Baseline, post-therapy, 6 months and 12 months after therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 - 64 yrs old patients who seek treatment at Grady Health System (GHS) after a suicide attempt African American speak English Exclusion Criteria: cognitive impairments medical instability
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadine Kaslow, PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grady Memorial Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33884617
Citation
Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
Results Reference
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Group Interventions for Suicidal African Americans

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