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NCT Number: NCT00601939

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

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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Key information

Conditions

Battered Women Behavior Behavioral Symptoms Self-Injurious Behavior Suicide Suicide, Attempted

Age range

18 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Grady Hospital

Atlanta, Georgia, 30303, United States

Location status: Recruiting

Location contact

Nadine J. Kaslow, PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychoeducational intervention (PEI)

Behavioral

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 names: Theory of triadic influence

Enhanced Treatment as Usual (ETAU)

Behavioral

ETAU contains an adherence protocol plus access to weekly support group and a resource room.

Primary outcomes

  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 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.

  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 outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Barbara D'Orio, MD

CONTACT

[email protected]

404-616-4760

Nadine J. Kaslow, PhD

CONTACT

[email protected]

404-616-4757

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Group Interventions for Abused, Suicidal Black Women

Important dates

Study start
2008
Primary completion
2028
Study completion
2028
First posted
Jan 28, 2008
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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