<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <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/NCT02227160</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00073021</org_study_id>
    <nct_id>NCT02227160</nct_id>
  </id_info>
  <brief_title>Group Interventions for Suicidal African Americans</brief_title>
  <official_title>Group Interventions for Suicidal African Americans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Emory University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigator is conducting a hybrid efficacy-effectiveness randomized controlled trial&#xD;
      with low-income African American suicide attempters. Guided by the Theory of Triadic&#xD;
      Influence (TTI), this pilot randomized controlled trial aims:&#xD;
&#xD;
        1. to determine if psychosocial group intervention (PGI) is more effective than enhanced&#xD;
           treatment as usual (ETAU) in reducing suicidal behavior (ideation, attempts; primary&#xD;
           outcome) and improving its correlates (depressive symptoms, hopelessness, quality of&#xD;
           life) (secondary outcomes) in low-income African Americans with a recent attempt.&#xD;
&#xD;
        2. to determine if PGI is more effective than ETAU at bolstering intrapersonal (I),&#xD;
           social/situational (SS), and cultural/environmental (CE) risk and protective factors&#xD;
           that mediate the condition-suicidal behavior and correlates link and thus serve as&#xD;
           mechanisms of change.&#xD;
&#xD;
        3. to determine I, SS, and CE variables that moderate the condition-suicidal behavior link&#xD;
           and thus serve as predictors of intervention outcome.&#xD;
&#xD;
      Hypothesis for Aim 1: At post-intervention and follow-up, PGI participants will evidence&#xD;
      greater improvements in suicidal behavior and its correlates than those in ETAU.&#xD;
&#xD;
      Hypothesis for Aim 2: Changes in these risk and protective factors will account for condition&#xD;
      effects on outcomes: (1) psychological distress, aggression, impulsivity, substance abuse,&#xD;
      low self-esteem, and suicide acceptability (I-risk); (2) perceived burdensomeness and&#xD;
      thwarted belongingness, relationship discord, intimate partner violence perpetration and&#xD;
      victimization (SS-risk); (3) access to a weapon and barriers to service utilization&#xD;
      (CE-risk); (4) reasons for living, optimism, positive ethnic identity, effective coping, and&#xD;
      spiritual well-being (I-protective); (5) overall family health and social support from family&#xD;
      and friends (SS-protective); and (6) religious involvement and effectiveness of obtaining&#xD;
      resources (CE-protective).&#xD;
&#xD;
      Hypothesis for Aim 3: Individuals (1) having fewer Diagnostic and Statistical Manual of&#xD;
      Mental Disorders (DSM) disorders and attachment styles characterized by positivity toward the&#xD;
      self and others (I); (2) children and more limited trauma histories (SS); and (3) more daily&#xD;
      hassles and less exposure to community disorder (CE) will evidence greater reductions in&#xD;
      suicidal behavior and its correlates and greater enhancements in quality of life at&#xD;
      post-intervention and follow-up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Attention will be paid to Theory of Triadic Influence intrapersonal, social/ situational, and&#xD;
      cultural/ environmental risk and protective factors that impact outcomes. The central&#xD;
      hypothesis is that compared to enhanced treatment as usual, through targeting Theory of&#xD;
      Triadic Influence-risk and protective factors the culturally-informed, Theory of Triadic&#xD;
      Influence-driven, empowerment based psychosocial group intervention will more positively&#xD;
      alter trajectories in suicidal behaviors and its correlates. The rationale is that upon study&#xD;
      completion, if data support the psychosocial group intervention value, they will facilitate&#xD;
      our long-term goal of disseminating evidence-based culturally-relevant interventions.&#xD;
&#xD;
      In order to test the hypothesis that at post-intervention and 6 and 12-month follow-up,&#xD;
      compared to individuals in ETAU, those in the PGI will endorse less I, SS, and CE risk&#xD;
      factors, reduced suicidal ideation, depressive symptoms, and hopelessness, and greater levels&#xD;
      of I, SS, and CE protective factors as well as increased quality of life, the study&#xD;
      procedures will be as follows: Male and female participants between the ages of 18-64 will be&#xD;
      recruited in the medical and psychiatric emergency rooms at GHS. Once the individual has been&#xD;
      medically cleared and has provided informed consent, he/she will be screened for study&#xD;
      appropriateness by trained project team members (10-20 minutes). If he/she meets inclusion&#xD;
      criteria, study participation will include a 3-hour interview. All study measures will be&#xD;
      read to each participant. Measures will assess background variables, suicidal behavior,&#xD;
      depressive symptoms, hopelessness, quality of life, and I, SS, and CE risk and protective&#xD;
      factors. All measures are psychometrically sound and appropriate for use with an African&#xD;
      American population. Once the interview is over, the participant will be randomly assigned to&#xD;
      either the PGI (10 group therapy sessions) or the ETAU condition (participation in a support&#xD;
      group focused on suicidal behaviors plus suicidal behavior monitoring and help with accessing&#xD;
      resources). The PGI, conducted in accord with the culturally informed, TTI-guided, and&#xD;
      empowerment based group protocol, and the support group will be unstructured; both groups&#xD;
      will last 120 minutes. Following the completion of the PGI or ETAU condition, the individuals&#xD;
      will be assessed at post-intervention (3 hours), and at 6 month and 12 month follow-ups (3&#xD;
      hours each). To increase retention and reduce suicide risk, reminder phone calls will be made&#xD;
      and texts sent on Relieflink, a suicide prevention app that received 1st prize in an App&#xD;
      Challenge sponsored by Substance Abuse and Mental Health Services Administration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    This study never started enrolling participants due to lack of grant funding.&#xD;
  </why_stopped>
  <start_date>May 2016</start_date>
  <completion_date type="Actual">May 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</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>Change in scores on Beck Scale for Suicidal Ideation</measure>
    <time_frame>Baseline, post-therapy, 6 months and 12 months after therapy</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in scores on Beck Depression Inventory - II</measure>
    <time_frame>Baseline, post-therapy, 6 months and 12 months after therapy</time_frame>
    <description>Beck Depression Inventory - II is a 21-item, self-reported questionnaire used to assess characteristics of depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in scores on Beck Hopelessness Scale</measure>
    <time_frame>Baseline, post-therapy, 6 months and 12 months after therapy</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in scores on WHO Quality of Life Brief Instrument</measure>
    <time_frame>Baseline, post-therapy, 6 months and 12 months after therapy</time_frame>
    <description>The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction</measure>
    <time_frame>12 months</time_frame>
    <description>Intervention Satisfaction Survey (ISS)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in the Symptom Checklist 90-Revised (SCL 90-R) scale</measure>
    <time_frame>Baseline, post-therapy, 6 months and 12 months after therapy</time_frame>
    <description>Symptom Checklist 90-Revised (SCL 90-R) questionnaire measures overall levels of psychological and physical functioning.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in scores for Alcohol Use Disorders Identification Test</measure>
    <time_frame>Baseline, post-therapy, 6 months and 12 months after therapy</time_frame>
    <description>Alcohol Use Disorders Identification Test (AUDIT) is a 10 question test to determine if a person's alcohol consumption may be harmful</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in scores on Drug Abuse Screening Test</measure>
    <time_frame>Baseline, post-therapy, 6 months and 12 months after therapy</time_frame>
    <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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in scores on Rosenberg Self-Esteem Scale (RSE)</measure>
    <time_frame>Baseline, post-therapy, 6 months and 12 months after therapy</time_frame>
    <description>A 10-item scale that measures global self-worth by measuring both positive and negative feelings about the self.</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in scores on Short Form Buss-Perry Aggression Questionnaire</measure>
    <time_frame>Baseline, post-therapy, 6 months and 12 months after therapy</time_frame>
    <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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in scores on Barratt Impulsiveness Scale</measure>
    <time_frame>Baseline, post-therapy, 6 months and 12 months after therapy</time_frame>
    <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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in scores on Suicide Acceptability Scale</measure>
    <time_frame>Baseline, post-therapy, 6 months and 12 months after therapy</time_frame>
    <description>Suicide Acceptability Scale is an 8-item measure of suicide acceptability</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in scores on Interpersonal Needs Questionnaire (INQ)</measure>
    <time_frame>Baseline, post-therapy, 6 months and 12 months after therapy</time_frame>
    <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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in scores on Dyadic Adjustment Scale</measure>
    <time_frame>Baseline, post-therapy, 6 months and 12 months after therapy</time_frame>
    <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</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in scores on Conflict Tactics Scale-Revised</measure>
    <time_frame>Baseline, post-therapy, 6 months and 12 months after therapy</time_frame>
    <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</description>
  </other_outcome>
  <other_outcome>
    <measure>Clinical Demographic Questionnaire</measure>
    <time_frame>Baseline</time_frame>
    <description>Demographic questionnaire assesses demographic information as well as information regarding to access to weapons</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in scores on Reasons for Living Inventory</measure>
    <time_frame>Baseline, post-therapy, 6 months and 12 months after therapy</time_frame>
    <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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in scores on Life Orientation Test - Revised</measure>
    <time_frame>Baseline, post-therapy, 6 months and 12 months after therapy</time_frame>
    <description>Life Orientation Test - Revised is a 10-item test assessing generalized positive outcome expectancies</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in scores on Multi-dimensional Inventory of Black Identity</measure>
    <time_frame>Baseline, post-therapy, 6 months and 12 months after therapy</time_frame>
    <description>The Multi-dimensional Inventory of Black Identity is designed to assess the three cross-situationally stable dimensions (Centrality, Regard, and Ideology)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in scores on Ways of Coping (Revised) Questionnaire</measure>
    <time_frame>Baseline, post-therapy, 6 months and 12 months after therapy</time_frame>
    <description>Ways of Coping (Revised) is self-reported questionnaire used to assess adaptive and maladaptive ways to cope with negative emotions or problematic situations</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in scores on Africultural Coping Systems Inventory</measure>
    <time_frame>Baseline, post-therapy, 6 months and 12 months after therapy</time_frame>
    <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</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in scores on Barriers to Accessing Services Scale</measure>
    <time_frame>Baseline, post-therapy, 6 months and 12 months after therapy</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in scores on Spiritual Well-Being Scale</measure>
    <time_frame>Baseline, post-therapy, 6 months and 12 months after therapy</time_frame>
    <description>Spiritual Well-Being Scale is a 20-item scale used for the assessment of both individual and congregational spiritual well-being</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in scores on Family Assessment Device</measure>
    <time_frame>Baseline, post-therapy, 6 months and 12 months after therapy</time_frame>
    <description>Family Assessment Device is a 53 item questionnaire designed to evaluate families.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in scores on Social Support Behaviors Scale</measure>
    <time_frame>Baseline, post-therapy, 6 months and 12 months after therapy</time_frame>
    <description>Social Support Behaviors Scale is designed to assess supportive behavior available from family and from friends.</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in scores on Multidimensional Measure of Religious Involvement for African Americans</measure>
    <time_frame>Baseline, post-therapy, 6 months and 12 months after therapy</time_frame>
    <description>Multidimensional Measure of Religious Involvement for African Americans is a 12-item scale measuring religious indicators.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in score on Effectiveness of Obtaining Resources questionnaire</measure>
    <time_frame>Baseline, post-therapy, 6 months and 12 months after therapy</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in evaluation on Structured Clinical Interview for DSM-5-Research Version</measure>
    <time_frame>Baseline, post-therapy, 6 months and 12 months after therapy</time_frame>
    <description>Structured Clinical Interview for DSM-5-Research Version is semi-structured interview that allows researchers to make clinical diagnoses according to DSM criteria</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in evaluation on Structured Clinical Interview for DSM-PD</measure>
    <time_frame>Baseline, post-therapy, 6 months and 12 months after therapy</time_frame>
    <description>The Structured Clinical Interview for DSM-PD is a semi-structured interview for making DSM-IV Axis II: Personality Disorder diagnoses</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in scores on Relationship Scales Questionnaire</measure>
    <time_frame>Baseline, post-therapy, 6 months and 12 months after therapy</time_frame>
    <description>Relationship Scales Questionnaire is a scale that consists of 17 items to assess attachment patterns.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in scores on Childhood Trauma Questionnaire - Short Form (CTQ-SF)</measure>
    <time_frame>Baseline, post-therapy, 6 months and 12 months after therapy</time_frame>
    <description>The CTQ-SF is a 28-item self-report instrument for adults and adolescents that assesses retrospective child abuse and neglect</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in scores on Survey of Recent Life Experiences scale</measure>
    <time_frame>Baseline, post-therapy, 6 months and 12 months after therapy</time_frame>
    <description>Survey of Recent Life Experiences is a 51-item self-report instrument that measures hassles for adults</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in scores on Community Disorder Scale</measure>
    <time_frame>Baseline, post-therapy, 6 months and 12 months after therapy</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Depression</condition>
  <condition>Mental Illness</condition>
  <condition>Suicide</condition>
  <condition>Suicidal Ideation</condition>
  <arm_group>
    <arm_group_label>Psychosocial group intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will seek outpatient counseling, support groups, in addition to 10 weekly group meetings</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will seek outpatient counseling and support groups only</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>10 weekly group meetings</intervention_name>
    <description>10 weekly group meetings with up to five other men and women at Grady Health System</description>
    <arm_group_label>Psychosocial group intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Outpatient counseling and support groups</intervention_name>
    <description>Usual mental health care</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Psychosocial group intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 - 64 yrs old&#xD;
&#xD;
          -  patients who seek treatment at Grady Health System (GHS) after a suicide attempt&#xD;
&#xD;
          -  African American&#xD;
&#xD;
          -  speak English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cognitive impairments&#xD;
&#xD;
          -  medical instability&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nadine Kaslow, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Grady Memorial Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>December 13, 2017</last_update_submitted>
  <last_update_submitted_qc>December 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Nadine Kaslow, PhD</investigator_full_name>
    <investigator_title>Nadine Kaslow PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Suicide</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
    <mesh_term>Suicidal Ideation</mesh_term>
  </condition_browse>
  <!-- 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/NCT02227160
org study id: IRB00073021
nct id: NCT02227160
lead sponsor: 
has dmc: Yes
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:

        1. 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.

        2. 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.

        3. 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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in scores on Beck Scale for Suicidal Ideation
time frame: Baseline, post-therapy, 6 months and 12 months after therapy
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.
measure: Change in scores on Beck Depression Inventory - II
time frame: Baseline, post-therapy, 6 months and 12 months after therapy
description: Beck Depression Inventory - II is a 21-item, self-reported questionnaire used to assess characteristics of depression.
measure: Change in scores on Beck Hopelessness Scale
time frame: Baseline, post-therapy, 6 months and 12 months after therapy
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
measure: Change in scores on WHO Quality of Life Brief Instrument
time frame: Baseline, post-therapy, 6 months and 12 months after therapy
description: The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment.
measure: Patient Satisfaction
time frame: 12 months
description: Intervention Satisfaction Survey (ISS)
measure: Change in the Symptom Checklist 90-Revised (SCL 90-R) scale
time frame: Baseline, post-therapy, 6 months and 12 months after therapy
description: Symptom Checklist 90-Revised (SCL 90-R) questionnaire measures overall levels of psychological and physical functioning.
measure: Change in scores for Alcohol Use Disorders Identification Test
time frame: Baseline, post-therapy, 6 months and 12 months after therapy
description: Alcohol Use Disorders Identification Test (AUDIT) is a 10 question test to determine if a person's alcohol consumption may be harmful
measure: Change in scores on Drug Abuse Screening Test
time frame: Baseline, post-therapy, 6 months and 12 months after therapy
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.
measure: Change in scores on Rosenberg Self-Esteem Scale (RSE)
time frame: Baseline, post-therapy, 6 months and 12 months after therapy
description: A 10-item scale that measures global self-worth by measuring both positive and negative feelings about the self.
measure: Changes in scores on Short Form Buss-Perry Aggression Questionnaire
time frame: Baseline, post-therapy, 6 months and 12 months after therapy
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.
measure: Changes in scores on Barratt Impulsiveness Scale
time frame: Baseline, post-therapy, 6 months and 12 months after therapy
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.
measure: Change in scores on Suicide Acceptability Scale
time frame: Baseline, post-therapy, 6 months and 12 months after therapy
description: Suicide Acceptability Scale is an 8-item measure of suicide acceptability
measure: Changes in scores on Interpersonal Needs Questionnaire (INQ)
time frame: Baseline, post-therapy, 6 months and 12 months after therapy
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.
measure: Change in scores on Dyadic Adjustment Scale
time frame: Baseline, post-therapy, 6 months and 12 months after therapy
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
measure: Change in scores on Conflict Tactics Scale-Revised
time frame: Baseline, post-therapy, 6 months and 12 months after therapy
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
measure: Clinical Demographic Questionnaire
time frame: Baseline
description: Demographic questionnaire assesses demographic information as well as information regarding to access to weapons
measure: Change in scores on Reasons for Living Inventory
time frame: Baseline, post-therapy, 6 months and 12 months after therapy
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.
measure: Change in scores on Life Orientation Test - Revised
time frame: Baseline, post-therapy, 6 months and 12 months after therapy
description: Life Orientation Test - Revised is a 10-item test assessing generalized positive outcome expectancies
measure: Change in scores on Multi-dimensional Inventory of Black Identity
time frame: Baseline, post-therapy, 6 months and 12 months after therapy
description: The Multi-dimensional Inventory of Black Identity is designed to assess the three cross-situationally stable dimensions (Centrality, Regard, and Ideology)
measure: Change in scores on Ways of Coping (Revised) Questionnaire
time frame: Baseline, post-therapy, 6 months and 12 months after therapy
description: Ways of Coping (Revised) is self-reported questionnaire used to assess adaptive and maladaptive ways to cope with negative emotions or problematic situations
measure: Change in scores on Africultural Coping Systems Inventory
time frame: Baseline, post-therapy, 6 months and 12 months after therapy
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
measure: Change in scores on Barriers to Accessing Services Scale
time frame: Baseline, post-therapy, 6 months and 12 months after therapy
measure: Change in scores on Spiritual Well-Being Scale
time frame: Baseline, post-therapy, 6 months and 12 months after therapy
description: Spiritual Well-Being Scale is a 20-item scale used for the assessment of both individual and congregational spiritual well-being
measure: Change in scores on Family Assessment Device
time frame: Baseline, post-therapy, 6 months and 12 months after therapy
description: Family Assessment Device is a 53 item questionnaire designed to evaluate families.
measure: Change in scores on Social Support Behaviors Scale
time frame: Baseline, post-therapy, 6 months and 12 months after therapy
description: Social Support Behaviors Scale is designed to assess supportive behavior available from family and from friends.
measure: Changes in scores on Multidimensional Measure of Religious Involvement for African Americans
time frame: Baseline, post-therapy, 6 months and 12 months after therapy
description: Multidimensional Measure of Religious Involvement for African Americans is a 12-item scale measuring religious indicators.
measure: Change in score on Effectiveness of Obtaining Resources questionnaire
time frame: Baseline, post-therapy, 6 months and 12 months after therapy
measure: Change in evaluation on Structured Clinical Interview for DSM-5-Research Version
time frame: Baseline, post-therapy, 6 months and 12 months after therapy
description: Structured Clinical Interview for DSM-5-Research Version is semi-structured interview that allows researchers to make clinical diagnoses according to DSM criteria
measure: Change in evaluation on Structured Clinical Interview for DSM-PD
time frame: Baseline, post-therapy, 6 months and 12 months after therapy
description: The Structured Clinical Interview for DSM-PD is a semi-structured interview for making DSM-IV Axis II: Personality Disorder diagnoses
measure: Change in scores on Relationship Scales Questionnaire
time frame: Baseline, post-therapy, 6 months and 12 months after therapy
description: Relationship Scales Questionnaire is a scale that consists of 17 items to assess attachment patterns.
measure: Change in scores on Childhood Trauma Questionnaire - Short Form (CTQ-SF)
time frame: Baseline, post-therapy, 6 months and 12 months after therapy
description: The CTQ-SF is a 28-item self-report instrument for adults and adolescents that assesses retrospective child abuse and neglect
measure: Change in scores on Survey of Recent Life Experiences scale
time frame: Baseline, post-therapy, 6 months and 12 months after therapy
description: Survey of Recent Life Experiences is a 51-item self-report instrument that measures hassles for adults
measure: Change in scores on Community Disorder Scale
time frame: Baseline, post-therapy, 6 months and 12 months after therapy
arm group label: Psychosocial group intervention
arm group type: Experimental
description: Subjects will seek outpatient counseling, support groups, in addition to 10 weekly group meetings
arm group label: Control
arm group type: Active Comparator
description: Subjects will seek outpatient counseling and support groups only
intervention type: Behavioral
intervention name: 10 weekly group meetings
description: 10 weekly group meetings with up to five other men and women at Grady Health System
arm group label: Psychosocial group intervention
intervention type: Behavioral
intervention name: Outpatient counseling and support groups
description: Usual mental health care
arm group label: Control
arm group label: Psychosocial group intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: No
last name: Nadine Kaslow, PhD
role: Principal Investigator
affiliation: Emory University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: Nadine Kaslow, PhD
investigator title: Nadine Kaslow PhD
mesh term: Suicide
mesh term: Mental Disorders
mesh term: Suicidal Ideation