Effectiveness of Empowerment Group Sessions for Treating Suicidal African American Women in Abusive Relationships
Primary Purpose
Battered Women, Suicide, Attempted
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psychoeducational intervention (PEI)
Enhanced treatment as usual (ETAU)
Sponsored by
About this trial
This is an interventional treatment trial for Battered Women focused on measuring Abused, Female, African American, Group Empowerment Psychoeducational Intervention, Enhanced Treatment as Usual
Eligibility Criteria
Inclusion Criteria:
- Identifies as an African-American female
- Abusive relationship within the 12 months prior to study entry
- Suicide attempt within the 12 months prior to study entry
- Seeks services at Grady Health System
Exclusion Criteria:
- Score of less than 22 on Mini Mental Status Exam (MMSE)
- Score of less than 18 on Rapid Estimate of Adult Literacy in Medicine (REALM)
- Acutely psychotic
Sites / Locations
- Grady HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Psychoeducational intervention (PEI)
Enhanced Treatment as Usual
Arm Description
Culturally competent group empowerment psychoeducational treatment (group intervention that is culturally informed and educational in nature)
Enhanced treatment as usual that includes an adherence protocol (regular care at the hospital plus an adherence protocol)
Outcomes
Primary Outcome Measures
Change in Beck Scale for Suicide Ideation Score
The Beck Scale for Suicide (BSS) Ideation consists of 19 items with responses rated on a scale from 0 to 2. Total scores range from 0 to 38 with higher scores indicating greater feelings of suicide ideation.
Change in Suicide Attempt Index
Created for this study, this qualitative screening measure asks if participants have engaged in the suicidal behaviors of intentionally overdosing, cutting self, tried to shoot self or jump from a high place, tried to take life, and attempting suicide.
Change in Index of Spouse Abuse Score
The Index of Spouse Abuse (ISA) is a 30-item instrument where participants report how frequently abuse situations occur where 1 = never and 5 = very frequently. Total scores range from 30 to 150 and higher scores indicate a higher degree of abuse.
Secondary Outcome Measures
Change in Beck Depression Inventory- II
The Beck Depression Inventory-II is a 21-item questionnaire where items are scored from 0 to 3, with higher scores assigned to more severe symptoms. Total scores range from 0 to 63, with higher scores indicating greater severity of depressive symptoms.
Change in Beck Hopelessness Scale
The Beck Hopelessness Scale is a 20-item instrument where each statement is answered as being true or false. Optimistic responses are scored as 0 while pessimistic responses are scored as 1. Total scores range from 0 to 20 and higher scores indicate greater feelings of hopelessness.
Change in Self-Efficacy Scale for Battered Women
The Self-Efficacy Scale for Battered Women is a 12-item instrument where participants report how confident they are about performing tasks related to asking for help and taking control of their lives. Items are scored on a scale of 0 to 100 where 0 = couldn't do it at all and 100 = completely sure I could do it. Total raw scores range from 1 to 1200, where higher scores indicate increased self efficacy.
Full Information
NCT ID
NCT00601939
First Posted
January 15, 2008
Last Updated
October 24, 2023
Sponsor
Emory University
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00601939
Brief Title
Effectiveness of Empowerment Group Sessions for Treating Suicidal African American Women in Abusive Relationships
Official Title
Group Interventions for Abused, Suicidal Black Women
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2008 (undefined)
Primary Completion Date
December 2028 (Anticipated)
Study Completion Date
December 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will evaluate the effectiveness of culturally competent psychoeducational empowerment sessions in treating suicidal African-American women who are in abusive relationships.
Detailed Description
Most suicide attempts are a sign of great distress, often originating from depression; physical and sexual abuse; substance abuse; or family history of suicide, violence, or mental disorder. Risk factors for suicidal behavior are diverse, differing with gender, age, and ethnicity. Since the mid-1980s, the number of reported suicides and suicidal thoughts among young black individuals has increased alarmingly. The higher rates may be caused by high stress living situations attributed to poverty, abuse, discrimination, racism, and difficult family life. Therefore, cultural environments, social situations, and intrapersonal influences are important considerations in developing an effective therapy to prevent suicide. This study will evaluate the effect of culturally competent psychoeducational empowerment sessions in treating suicidal African-American women who are in abusive relationships.
The participants in this single-blind study will be randomly placed in one of two treatment groups. One group will receive psychoeducational intervention (PEI) and the other will receive enhanced treatment as usual (ETAU). After screening, eligible participants will complete a 2-hour survey about life events, concerns, and feelings with a research team member. One week later, participants will complete a second 1-hour survey. Participants will then be randomly placed in the treatment groups. Participants in both groups will receive treatment at Grady Health System, but those in the PEI group will also attend 10 weekly, 90-minute group sessions. The PEI empowerment group sessions will incorporate cultural, social, and intrapersonal elements. The ETAU group will be given mental health treatment as usual plus an adherence enhancement protocol. Follow-up surveys will occur at Week 10 (after treatment completion) and at Months 6 and 12 post-treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Battered Women, Suicide, Attempted
Keywords
Abused, Female, African American, Group Empowerment Psychoeducational Intervention, Enhanced Treatment as Usual
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
397 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Psychoeducational intervention (PEI)
Arm Type
Experimental
Arm Description
Culturally competent group empowerment psychoeducational treatment (group intervention that is culturally informed and educational in nature)
Arm Title
Enhanced Treatment as Usual
Arm Type
Active Comparator
Arm Description
Enhanced treatment as usual that includes an adherence protocol (regular care at the hospital plus an adherence protocol)
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducational intervention (PEI)
Other Intervention Name(s)
Theory of triadic influence
Intervention Description
PEI consists of 10 culturally competent group empowerment psychoeducational sessions. The sessions are directed by a treatment manual and are co-led by two therapists. The sessions are guided by the theory of triadic influence (TTI) model, which incorporates cultural-environmental influences, social-situational influences, and intrapersonal influences into treatment.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced treatment as usual (ETAU)
Intervention Description
ETAU contains an adherence protocol plus access to weekly support group and a resource room.
Primary Outcome Measure Information:
Title
Change in Beck Scale for Suicide Ideation Score
Description
The Beck Scale for Suicide (BSS) Ideation consists of 19 items with responses rated on a scale from 0 to 2. Total scores range from 0 to 38 with higher scores indicating greater feelings of suicide ideation.
Time Frame
Baseline, Week 10, Post-treatment Months 6 and 12
Title
Change in Suicide Attempt Index
Description
Created for this study, this qualitative screening measure asks if participants have engaged in the suicidal behaviors of intentionally overdosing, cutting self, tried to shoot self or jump from a high place, tried to take life, and attempting suicide.
Time Frame
Baseline, Week 10, Post-treatment Months 6 and 12
Title
Change in Index of Spouse Abuse Score
Description
The Index of Spouse Abuse (ISA) is a 30-item instrument where participants report how frequently abuse situations occur where 1 = never and 5 = very frequently. Total scores range from 30 to 150 and higher scores indicate a higher degree of abuse.
Time Frame
Baseline, Week 10, Post-treatment Months 6 and 12
Secondary Outcome Measure Information:
Title
Change in Beck Depression Inventory- II
Description
The Beck Depression Inventory-II is a 21-item questionnaire where items are scored from 0 to 3, with higher scores assigned to more severe symptoms. Total scores range from 0 to 63, with higher scores indicating greater severity of depressive symptoms.
Time Frame
Baseline, Week 10, Post-treatment Months 6 and 12
Title
Change in Beck Hopelessness Scale
Description
The Beck Hopelessness Scale is a 20-item instrument where each statement is answered as being true or false. Optimistic responses are scored as 0 while pessimistic responses are scored as 1. Total scores range from 0 to 20 and higher scores indicate greater feelings of hopelessness.
Time Frame
Baseline, Week 10, Post-treatment Months 6 and 12
Title
Change in Self-Efficacy Scale for Battered Women
Description
The Self-Efficacy Scale for Battered Women is a 12-item instrument where participants report how confident they are about performing tasks related to asking for help and taking control of their lives. Items are scored on a scale of 0 to 100 where 0 = couldn't do it at all and 100 = completely sure I could do it. Total raw scores range from 1 to 1200, where higher scores indicate increased self efficacy.
Time Frame
Baseline, Week 10, Post-treatment Months 6 and 12
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Identifies as an African-American female
Abusive relationship within the 12 months prior to study entry
Suicide attempt within the 12 months prior to study entry
Seeks services at Grady Health System
Exclusion Criteria:
Score of less than 22 on Mini Mental Status Exam (MMSE)
Score of less than 18 on Rapid Estimate of Adult Literacy in Medicine (REALM)
Acutely psychotic
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nadine J. Kaslow, PhD
Phone
404-616-4757
Email
nkaslow@emory.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Barbara D'Orio, MD
Phone
404-616-4760
Email
bdorio@emory.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadine J. Kaslow, PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grady Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadine J. Kaslow, PhD
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
derived
Learn more about this trial
Effectiveness of Empowerment Group Sessions for Treating Suicidal African American Women in Abusive Relationships
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