Effectiveness of Empowerment Group Sessions for Treating Suicidal African American Women in Abusive Relationships
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|ClinicalTrials.gov Identifier: NCT00601939|
Recruitment Status : Suspended (Enrollment and study activities are temporarily suspended due to COVID-19.)
First Posted : January 28, 2008
Last Update Posted : May 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Battered Women Suicide, Attempted||Behavioral: Psychoeducational intervention (PEI) Behavioral: Enhanced treatment as usual (ETAU)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||397 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Group Interventions for Abused, Suicidal Black Women|
|Study Start Date :||March 2008|
|Estimated Primary Completion Date :||December 2028|
|Estimated Study Completion Date :||December 2028|
Experimental: Psychoeducational intervention (PEI)
Culturally competent group empowerment psychoeducational treatment (group intervention that is culturally informed and educational in nature)
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.
Other Name: Theory of triadic influence
Active Comparator: Enhanced Treatment as Usual
Enhanced treatment as usual that includes an adherence protocol (regular care at the hospital plus an adherence protocol)
Behavioral: Enhanced treatment as usual (ETAU)
ETAU contains an adherence protocol plus access to weekly support group and a resource room.
- Change in Beck Scale for Suicide Ideation Score [ Time Frame: Baseline, Week 10, Post-treatment Months 6 and 12 ]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 [ Time Frame: Baseline, Week 10, Post-treatment Months 6 and 12 ]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 [ Time Frame: Baseline, Week 10, Post-treatment Months 6 and 12 ]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.
- Change in Beck Depression Inventory- II [ Time Frame: Baseline, Week 10, Post-treatment Months 6 and 12 ]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 [ Time Frame: Baseline, Week 10, Post-treatment Months 6 and 12 ]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 [ Time Frame: Baseline, Week 10, Post-treatment Months 6 and 12 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00601939
|United States, Georgia|
|Atlanta, Georgia, United States, 30303|
|Principal Investigator:||Nadine J. Kaslow, PhD||Emory University|