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| Tracking Information | |||||||||
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| First Received Date † | January 15, 2008 | ||||||||
| Last Updated Date | March 12, 2009 | ||||||||
| Start Date † | March 2008 | ||||||||
| Current Primary Outcome Measures † |
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 ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures † | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00601939 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures † |
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 ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures † | Same as current | ||||||||
| Descriptive Information | |||||||||
| 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 | ||||||||
| 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. |
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| 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. |
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| Study Phase | Phase IV | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Efficacy Study | ||||||||
| Condition † |
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| Intervention † |
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| Study Arms / Comparison Groups |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Estimated Enrollment † | 190 | ||||||||
| Estimated Completion Date | September 2012 | ||||||||
| Estimated Primary Completion Date | April 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years to 64 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Expanded Access Status | |||||||||
| Administrative Information | |||||||||
| NCT ID † | NCT00601939 | ||||||||
| Responsible Party | Nadine J. Kaslow, PhD, Emory University School of Medicine | ||||||||
| Secondary IDs †† | DSIR 83-ATP | ||||||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | March 2009 | ||||||||
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† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |
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