Effectiveness of Empowerment Group Sessions for Treating Suicidal African American Women in Abusive Relationships
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00601939|
Recruitment Status : Recruiting
First Posted : January 28, 2008
Last Update Posted : August 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Battered Women Suicide, Attempted||Behavioral: Psychoeducational intervention (PEI) Behavioral: Enhanced treatment as usual (ETAU)||Phase 4|
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 :||190 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Group Interventions for Abused, Suicidal Black Women|
|Study Start Date :||March 2008|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Culturally competent group empowerment psychoeducational treatment
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: 2
Enhanced treatment as usual that includes an adherence protocol
Behavioral: Enhanced treatment as usual (ETAU)
ETAU contains an adherence protocol plus access to weekly support group and a resource room.
- Beck Scale for Suicidal Ideation; Suicide Attempt Index; Index of Spouse Abuse [ Time Frame: Measured at Week 10 and Months 6 and 12 post-treatment ]
- Beck Depression Inventory - II; Beck Hopelessness Scale; Self Efficacy Scale for Battered Women [ Time Frame: Measured at Week 10 and Months 6 and 12 post-treatment ]
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
|Contact: Nadine J. Kaslow, PhDfirstname.lastname@example.org|
|Contact: Barbara D'Orio, MDemail@example.com|
|United States, Georgia|
|Atlanta, Georgia, United States, 30303|
|Principal Investigator: Nadine J. Kaslow, PhD|
|Principal Investigator:||Nadine J. Kaslow, PhD||Emory University|