Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2016-05-31
2017-05-31
Brief Summary
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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
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Psychosocial group intervention
Subjects will seek outpatient counseling, support groups, in addition to 10 weekly group meetings
10 weekly group meetings
10 weekly group meetings with up to five other men and women at Grady Health System
Outpatient counseling and support groups
Usual mental health care
Control
Subjects will seek outpatient counseling and support groups only
Outpatient counseling and support groups
Usual mental health care
Interventions
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10 weekly group meetings
10 weekly group meetings with up to five other men and women at Grady Health System
Outpatient counseling and support groups
Usual mental health care
Eligibility Criteria
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Inclusion Criteria
* patients who seek treatment at Grady Health System (GHS) after a suicide attempt
* African American
* speak English
Exclusion Criteria
* medical instability
18 Years
64 Years
ALL
No
Sponsors
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Emory University
OTHER
Responsible Party
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Nadine Kaslow, PhD
Nadine Kaslow PhD
Principal Investigators
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Nadine Kaslow, PhD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Grady Memorial Hospital
Atlanta, Georgia, United States
Countries
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References
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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.
Other Identifiers
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IRB00073021
Identifier Type: -
Identifier Source: org_study_id