Ignite Creation Date:
2024-05-06 @ 3:11 AM
Last Modification Date:
2024-10-26 @ 11:29 AM
Study NCT ID:
NCT02227160
Status:
WITHDRAWN
Last Update Posted:
2017-12-15
First Post:
2014-08-26
Brief Title:
Group Interventions for Suicidal African Americans
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Group Interventions for Suicidal African Americans
Status:
WITHDRAWN
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study never started enrolling participants due to lack of grant funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 socialsituational SS and culturalenvironmental 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
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 socialsituational SS and culturalenvironmental 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 heshe will be screened for study appropriateness by trained project team members 10-20 minutes If heshe 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
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 heshe will be screened for study appropriateness by trained project team members 10-20 minutes If heshe 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None