Clinical trial NCT02227160: Group Interventions for Suicidal African Americans
Official title: Group Interventions for Suicidal African Americans
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Depression
Mental Illness
Suicide
Suicidal Ideation
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2014-08-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.

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.

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

Primary outcomes:
measure: Change in scores on Beck Scale for Suicidal Ideation
timeFrame: Baseline, post-therapy, 6 months and 12 months after therapy
Secondary outcomes:
measure: Change in scores on Beck Depression Inventory - II
timeFrame: Baseline, post-therapy, 6 months and 12 months after therapy
measure: Change in scores on Beck Hopelessness Scale
timeFrame: Baseline, post-therapy, 6 months and 12 months after therapy
measure: Change in scores on WHO Quality of Life Brief Instrument
timeFrame: Baseline, post-therapy, 6 months and 12 months after therapy
measure: Patient Satisfaction
timeFrame: 12 months
Other outcomes:
measure: Change in the Symptom Checklist 90-Revised (SCL 90-R) scale
timeFrame: Baseline, post-therapy, 6 months and 12 months after therapy
measure: Change in scores for Alcohol Use Disorders Identification Test
timeFrame: Baseline, post-therapy, 6 months and 12 months after therapy
measure: Change in scores on Drug Abuse Screening Test
timeFrame: Baseline, post-therapy, 6 months and 12 months after therapy
measure: Change in scores on Rosenberg Self-Esteem Scale (RSE)
timeFrame: Baseline, post-therapy, 6 months and 12 months after therapy
measure: Changes in scores on Short Form Buss-Perry Aggression Questionnaire
timeFrame: Baseline, post-therapy, 6 months and 12 months after therapy
measure: Changes in scores on Barratt Impulsiveness Scale
timeFrame: Baseline, post-therapy, 6 months and 12 months after therapy
measure: Change in scores on Suicide Acceptability Scale
timeFrame: Baseline, post-therapy, 6 months and 12 months after therapy
measure: Changes in scores on Interpersonal Needs Questionnaire (INQ)
timeFrame: Baseline, post-therapy, 6 months and 12 months after therapy
measure: Change in scores on Dyadic Adjustment Scale
timeFrame: Baseline, post-therapy, 6 months and 12 months after therapy
measure: Change in scores on Conflict Tactics Scale-Revised
timeFrame: Baseline, post-therapy, 6 months and 12 months after therapy
measure: Clinical Demographic Questionnaire
timeFrame: Baseline
measure: Change in scores on Reasons for Living Inventory
timeFrame: Baseline, post-therapy, 6 months and 12 months after therapy
measure: Change in scores on Life Orientation Test - Revised
timeFrame: Baseline, post-therapy, 6 months and 12 months after therapy
measure: Change in scores on Multi-dimensional Inventory of Black Identity
timeFrame: Baseline, post-therapy, 6 months and 12 months after therapy
measure: Change in scores on Ways of Coping (Revised) Questionnaire
timeFrame: Baseline, post-therapy, 6 months and 12 months after therapy
measure: Change in scores on Africultural Coping Systems Inventory
timeFrame: Baseline, post-therapy, 6 months and 12 months after therapy
measure: Change in scores on Barriers to Accessing Services Scale
timeFrame: Baseline, post-therapy, 6 months and 12 months after therapy
measure: Change in scores on Spiritual Well-Being Scale
timeFrame: Baseline, post-therapy, 6 months and 12 months after therapy
measure: Change in scores on Family Assessment Device
timeFrame: Baseline, post-therapy, 6 months and 12 months after therapy
measure: Change in scores on Social Support Behaviors Scale
timeFrame: Baseline, post-therapy, 6 months and 12 months after therapy
measure: Changes in scores on Multidimensional Measure of Religious Involvement for African Americans
timeFrame: Baseline, post-therapy, 6 months and 12 months after therapy
measure: Change in score on Effectiveness of Obtaining Resources questionnaire
timeFrame: Baseline, post-therapy, 6 months and 12 months after therapy
measure: Change in evaluation on Structured Clinical Interview for DSM-5-Research Version
timeFrame: Baseline, post-therapy, 6 months and 12 months after therapy
measure: Change in evaluation on Structured Clinical Interview for DSM-PD
timeFrame: Baseline, post-therapy, 6 months and 12 months after therapy
measure: Change in scores on Relationship Scales Questionnaire
timeFrame: Baseline, post-therapy, 6 months and 12 months after therapy
measure: Change in scores on Childhood Trauma Questionnaire - Short Form (CTQ-SF)
timeFrame: Baseline, post-therapy, 6 months and 12 months after therapy
measure: Change in scores on Survey of Recent Life Experiences scale
timeFrame: Baseline, post-therapy, 6 months and 12 months after therapy
measure: Change in scores on Community Disorder Scale
timeFrame: Baseline, post-therapy, 6 months and 12 months after therapy
Locations:
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Nadine Kaslow, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.