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

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ClinicalTrials.gov Identifier: NCT00601939
Recruitment Status : Recruiting
First Posted : January 28, 2008
Last Update Posted : September 23, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Nadine Kaslow, PhD, Emory University

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.

Condition or disease Intervention/treatment Phase
Battered Women Suicide, Attempted Behavioral: Psychoeducational intervention (PEI) Behavioral: Enhanced treatment as usual (ETAU) Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 397 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
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: 2
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.




Primary Outcome Measures :
  1. 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.

  2. Change in Suicide Attempt Index [ Time Frame: Baseline, Week 10, Post-treatment Months 6 and 12 ]
    Created for this study, this screening measure asks 5 questions regarding suicidal behavior: intentionally overdosed, cut self, tried to shoot self or jump from a high place, tried to take life, attempted suicide

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Nadine J. Kaslow, PhD 404-616-4757 nkaslow@emory.edu
Contact: Barbara D'Orio, MD 404-616-4760 bdorio@emory.edu

Locations
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United States, Georgia
Grady Hospital Recruiting
Atlanta, Georgia, United States, 30303
Principal Investigator: Nadine J. Kaslow, PhD         
Sponsors and Collaborators
Emory University
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Nadine J. Kaslow, PhD Emory University

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Responsible Party: Nadine Kaslow, PhD, Professor, Emory University
ClinicalTrials.gov Identifier: NCT00601939     History of Changes
Other Study ID Numbers: IRB00045774
R01MH078002 ( U.S. NIH Grant/Contract )
First Posted: January 28, 2008    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nadine Kaslow, PhD, Emory University:
Abused
Female
African American
Group Empowerment Psychoeducational Intervention
Enhanced Treatment as Usual
Additional relevant MeSH terms:
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Suicide
Suicide, Attempted
Self-Injurious Behavior
Behavioral Symptoms