Effectiveness of Empowerment Group Sessions for Treating Suicidal African American Women in Abusive Relationships

Suicide, Attempted Clinical Trial

Official title:

Group Interventions for Abused, Suicidal Black Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00601939
• Other study ID #: IRB00045774
• Secondary ID: R01MH078002
• Status: Recruiting
• Phase: N/A
• Start date: March 2008
• Est. completion date: December 2028

Study information

• Verified date: October 2023
• Source: Emory University
• Contact: Nadine J. Kaslow, PhD
• Phone: 404-616-4757
• Email: nkaslow[@]emory.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the effectiveness of culturally competent psychoeducational empowerment sessions in treating suicidal African-American women who are in abusive relationships.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 397
• Est. completion date: December 2028
• Est. primary completion date: December 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Battered Women
• Suicide
• Suicide, Attempted

Intervention

Behavioral:
• Psychoeducational intervention (PEI)
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.
• Enhanced treatment as usual (ETAU)
ETAU contains an adherence protocol plus access to weekly support group and a resource room.

Locations

Country	Name	City	State
United States	Grady Hospital	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Week 10, Post-treatment Months 6 and 12
Primary	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.	Baseline, Week 10, Post-treatment Months 6 and 12
Primary	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.	Baseline, Week 10, Post-treatment Months 6 and 12
Secondary	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.	Baseline, Week 10, Post-treatment Months 6 and 12
Secondary	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.	Baseline, Week 10, Post-treatment Months 6 and 12
Secondary	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.	Baseline, Week 10, Post-treatment Months 6 and 12