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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00601939 |
This study will evaluate the effectiveness of culturally competent psychoeducational empowerment sessions in treating suicidal African-American women who are in abusive relationships.
Condition | Intervention | Phase |
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Battered Women Suicide, Attempted |
Behavioral: Psychoeducational intervention (PEI) Behavioral: Enhanced treatment as usual (ETAU) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Group Interventions for Abused, Suicidal Black Women |
Estimated Enrollment: | 190 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | September 2012 |
Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Culturally competent group empowerment psychoeducational treatment
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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.
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2: Active Comparator
Enhanced treatment as usual that includes an adherence protocol
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Behavioral: Enhanced treatment as usual (ETAU)
ETAU contains an adherence protocol plus access to weekly support group and a resource room.
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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.
Ages Eligible for Study: | 18 Years to 64 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Nadine J. Kaslow, PhD | 404-616-4757 | nkaslow@emory.edu |
Contact: Barbara D'Orio, MD | 404-616-4760 | bdorio@emory.edu |
United States, Georgia | |
Grady Hospital | Recruiting |
Atlanta, Georgia, United States, 30303 | |
Principal Investigator: Nadine J. Kaslow, PhD |
Principal Investigator: | Nadine J. Kaslow, PhD | Emory University |
Responsible Party: | Emory University School of Medicine ( Nadine J. Kaslow, PhD ) |
Study ID Numbers: | R01 MH078002, DSIR 83-ATP |
Study First Received: | January 15, 2008 |
Last Updated: | March 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00601939 History of Changes |
Health Authority: | United States: Federal Government |
Abused Female African American Group Empowerment Psychoeducational Intervention Enhanced Treatment as Usual |
Suicide, Attempted Suicide Behavioral Symptoms Self-Injurious Behavior |
Suicide, Attempted Suicide Behavioral Symptoms Self-Injurious Behavior |