Battered WomenNCT00601939
Effectiveness of Empowerment Group Sessions for Treating Suicidal African American Women in Abusive Relationships
A study testing Psychoeducational intervention (PEI) and Enhanced treatment as usual (ETAU) in people with Battered Women and Suicide, Attempted, run by Emory University at 1 site in United States.
Trial summary
This study will evaluate the effectiveness of culturally competent psychoeducational empowerment sessions in treating suicidal African-American women who are in abusive relationships. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Battered Women, Suicide, Attempted
- What is being tested?
- Psychoeducational intervention (PEI) and Enhanced treatment as usual (ETAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Group Interventions for Abused, Suicidal Black Women
This study will evaluate the effectiveness of culturally competent psychoeducational empowerment sessions in treating suicidal African-American women who are in abusive relationships.
Read the 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.
- Conditions
- Battered Women, Suicide, Attempted
- Being tested
- Psychoeducational intervention (PEI), Enhanced treatment as usual (ETAU)
- Keywords
- Abused, Female, African American, Group Empowerment Psychoeducational Intervention, Enhanced Treatment as Usual
- Medical subject headings
- Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducational intervention (PEI)Behavioural
Also called Theory of triadic influence
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.
Enhanced treatment as usual (ETAU)Behavioural
ETAU contains an adherence protocol plus access to weekly support group and a resource room.
| Study group | Role | What they receive |
|---|---|---|
| Psychoeducational intervention (PEI) | Experimental | Culturally competent group empowerment psychoeducational treatment (group intervention that is culturally informed and educational in nature) Receives: Behavioral: Psychoeducational intervention (PEI) |
| Enhanced Treatment as Usual | Active comparator | Enhanced treatment as usual that includes an adherence protocol (regular care at the hospital plus an adherence protocol) Receives: Behavioral: Enhanced treatment as usual (ETAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Beck Scale for Suicide Ideation Score
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.
Measured: Baseline, Week 10, Post-treatment Months 6 and 12
Change in Suicide Attempt Index
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.
Measured: Baseline, Week 10, Post-treatment Months 6 and 12
Change in Index of Spouse Abuse Score
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.
Measured: Baseline, Week 10, Post-treatment Months 6 and 12
Secondary outcomes (3)
Change in Beck Depression Inventory- II
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.
Measured: Baseline, Week 10, Post-treatment Months 6 and 12
Change in Beck Hopelessness Scale
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.
Measured: Baseline, Week 10, Post-treatment Months 6 and 12
Change in Self-Efficacy Scale for Battered Women
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.
Measured: Baseline, Week 10, Post-treatment Months 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startMar 2008
- Primary completionSep 2024
- Study completionSep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Battered WomenStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Nadine Kaslow, Emory University
- Investigators
- Nadine J. Kaslow, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00601939
- Sponsor's protocol ID
- IRB00045774
- Other IDs
- R01MH078002, 2023P006313
- Status last verified
- Dec 2025
- First submitted
- 15 Jan 2008
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
PubMed 33884617
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Interventions for Abused, Suicidal Black Women
- ClinicalTrials.gov ID
- NCT00601939
- Acronym / sponsor ID
- IRB00045774
- Conditions
- Battered Women, Suicide, Attempted
- Keywords
- Abused, Female, African American, Group Empowerment Psychoeducational Intervention, Enhanced Treatment as Usual
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Mar 2008
- Primary completion
- Sep 2024 (actual)
- Study completion
- Sep 2024 (actual)
- First posted
- 28 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effectiveness of culturally competent psychoeducational empowerment sessions in treating suicidal African-American women who are in abusive relationships.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychoeducational intervention (PEI) | Experimental | Behavioral: Psychoeducational intervention (PEI)Culturally competent group empowerment psychoeducational treatment (group intervention that is culturally informed and educational in nature) |
| Enhanced Treatment as Usual | Active comparator | Behavioral: Enhanced treatment as usual (ETAU)Enhanced treatment as usual that includes an adherence protocol (regular care at the hospital plus an adherence protocol) |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychoeducational intervention (PEI)Also: Theory of triadic influencePEI 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. | Behavioural | Psychoeducational intervention (PEI) |
| Enhanced treatment as usual (ETAU)ETAU contains an adherence protocol plus access to weekly support group and a resource room. | Behavioural | Enhanced Treatment as Usual |
Primary outcome
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.
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.
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.
3 secondary outcomes
Change in Beck Depression Inventory- II
Time frame: Baseline, Week 10, Post-treatment Months 6 and 12
Change in Beck Hopelessness Scale
Time frame: Baseline, Week 10, Post-treatment Months 6 and 12
Change in Self-Efficacy Scale for Battered Women
Time frame: Baseline, Week 10, Post-treatment Months 6 and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Derived from this study: PubMed 33884617Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
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Not yet recruiting
Camouflaged WeChat-based Intervention for Abused Women
Domestic Violence, Mental Health Wellness 1
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadine J. Kaslow, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducational intervention (PEI) and Enhanced treatment as usual (ETAU) in people with Battered Women and Suicide, Attempted, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Beck Scale for Suicide Ideation Score (time frame: Baseline, Week 10, Post-treatment Months 6 and 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00601939, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.