ViolenceBSHAPENCT03664362
The BSHAPE Intervention Program for Safety and Health of Survivors of Cumulative Trauma
A study testing The BSHAPE Intervention in people with Violence and Cumulative Trauma, run by Johns Hopkins University at 1 site in United States.
Trial summary
The goal of the BSHAPE study is to test a trauma informed, culturally tailored, multicomponent program entitled BSHAPE (Being Safe, Healthy, And Positively Empowered) for immigrant survivors of cumulative trauma. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Violence, Cumulative Trauma, HIV Risk
- What is being tested?
- The BSHAPE Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2018to 19 Feb 2022
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-55 years of age
- Self-identify as a female
- Born in Africa or foreign born from African descent
- Must have a current or past abusive romantic relationship
- Must be a survivor of cumulative trauma
- Clinically significant symptoms of PTSD and/or depression
- At least one sexual HIV risk behavior
Who cannot join
- Less than 18 years of age or more than age 55
- Self-identify as a male
- Not African-born immigrant or born outside the US
- Is not a survivor of cumulative trauma
- Does not meet clinically significant criteria of PTSD and/or depression
- Does not report at least one sexual HIV risk behavior
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cumulative Victimization and Women's Health Risks: Development of an Intervention
The goal of the BSHAPE study is to test a trauma informed, culturally tailored, multicomponent program entitled BSHAPE (Being Safe, Healthy, And Positively Empowered) for immigrant survivors of cumulative trauma.
Read the detailed description
The central hypothesis is that the BSHAPE intervention will promote immigrant women's safety and health (e.g..,improved mental health, reduced physiological impact of stress and health inequities (especially reproductive-sexual health and HIV)), thus leading to overall empowerment.
The study will:
- Conduct a feasibility and acceptability evaluation of the BSHAPE intervention.
- Test the BSHAPE intervention for large scale implementation in community-based clinics and programs serving immigrant women.
The impact of BSHAPE will be evaluated in comparison to usual care in promoting safety and health outcomes among immigrant women with cumulative trauma experiences at post-intervention and at 6 and 12 months follow up.
- Conditions
- Violence, Cumulative Trauma, HIV Risk, Stress, Mental Health, Reproductive Health
- Being tested
- The BSHAPE Intervention
- Medical subject headings
- Psychological Well-Being, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The BSHAPE InterventionBehavioural
The BSHAPE intervention program key elements include strengths based assessments, individualized plans and support based on priorities and needs, motivational interviewing strategies, psychoeducation (education with skill building exercises), mindfulness activities, danger assessment, safety planning, behavioral activation and linkage to community resources
| Study group | Role | What they receive |
|---|---|---|
| The BSHAPE Intervention | Experimental | Participants in the BSHAPE intervention attend a 9 sessions program post-assessments which is a combination of individualized and group-based sessions. Receives: Behavioral: The BSHAPE Intervention |
| Usual care or no treatment control | No intervention | Participants in the control arm either are receiving no services or are engaged in usual care provided by community-based/health care organizations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depressive symptoms
The Patient Health Questionnaire (PHQ-9) is a 9 item measure to assess depression symptoms based on the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual (DSM-IV). Each of the 9 items scores from 0 (not at all) to 3 (nearly every day).
Measured: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
Change in symptoms of post-traumatic stress disorder (PTSD)
Harvard Trauma Questionnaire (16 items) is used to measure symptoms of PTSD derived from the DSM-IIR/DSM-IV criteria for PTSD. The scale for each question includes four categories of response: "Not at all," "A little," "Quite a bit," "Extremely," rated 1 to 4, respectively
Measured: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
Change in perceived stress
The Perceived stress scale is a 10 item self-report measure of stress. It is designed to assess how stressed one feels in the past month. Item responses are rated on a 5-point scale ranging from 0 (Never) to 4 (Very often). Higher scores indicate higher perceived stress. This scale is scored by summing the answers to all items, for a highest score of 40. Scores 0-13 indicate low stress, 14-26 is moderate stress and 27-40 is considered high stress.
Measured: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
Change in sexual risk behaviors
The Safe Sex Behavior Questionnaire is a 27-item self-report measure that describes sexual behaviors such as condom usage, sexual communication, and high-risk sexual behaviors. Item responses are rated on a 4-point scale ranging from 1 (Never) to 4 (Always). There are no subscales, and all items are summed to create a total score. Higher scores indicate engagement in safer sexual behaviors
Measured: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)]
Change in empowerment related to safety as assessed by the MOVERS scale
The MOVERS is a 13 item scale that measures empowerment within the domain of safety. Participants respond to each item using a five-point scale from 1- "never true" to 5 - "always true". A maximum total of 65 and minimum of 13. Higher scores indicate higher level of empowerment related to safety.
Measured: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
Secondary outcomes (9)
Change in overall empowerment as assessed by the Personal Progress Scale-Revised
The Personal Progress Scale-Revised is a 28 item self-report measure of empowerment designed to assess multiple areas associated with empowerment such as positive self-evaluation, self-esteem, ability to regulate emotional distress, gender-role and cultural identity awareness, self-efficacy, self-care, problem-solving, assertiveness skills, and access to resources. Item responses are rated on a 7-point scale ranging from 1 (Almost Never) to 7 (Almost Always). A total maximum composite score of 196 and a minimum of 28. Higher scores indicate higher level of empowerment.
Measured: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
Change in self-efficacy related to coping with trauma as assessed by the Trauma Coping Self-Efficacy scale
The Trauma Coping Self-Efficacy scale is a 9-item self-report scale aimed at assessing the belief in one's ability to cope with trauma. Items are rated in a 7-point scale ranging from 1 (Not at all capable) to 7 (Totally capable). All items are averaged, for a high score of seven. Higher scores indicate greater trauma coping self-efficacy.
Measured: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)]
Change in self-efficacy for HIV/Sexually Transmitted Infection (STI) prevention as assessed by the Self-Efficacy for STI-HIV Scale
The Self-Efficacy for STI-HIV Scale measures an individual's perceived ability to practice STD and HIV prevention strategies. The measure consists of 10 self-report items which are rated on a 5-point scale ranging from 1 (Not Sure) to 5 (Completely sure). All items are summed for a total score that can range from 10-50 with higher scores indicating higher self-efficacy.
Measured: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
Change in HIV knowledge using the HIV Knowledge Questionnaire
The HIV Knowledge Questionnaire is a 18-item self report measure designed to measure ones understanding of HIV transmission and prevention. Items are scored in a true-false format where one point is awarded for a correct answer. Incorrect answers and "don't know" is scored as zero. Items are summed for a total possible score of 18. Higher scores indicate greater knowledge about how HIV is transmitted and how it can be prevented.
Measured: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
Change in Sexually Transmitted Disease (STD) knowledge using the STD Knowledge Questionnaire
The STD Knowledge Questionnaire is a 27-item self-report measure designed to assess knowledge of transmission and prevention of common STDs such as Gonorrhea, Chlamydia, Hepatitis B, Human Papilloma Virus (HPV), and Genital Warts. Items are scored on a true-false scale where one point is awarded for each correct response. No points are given for incorrect responses or "Don't know". Items are summed to create a highest possible score of 27, with higher scores indicating high knowledge of how to prevent and transmit STDs.
Measured: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
Change in attitudes for stress management as assessed by the Inventory of Positive Psychological Attitudes
The Inventory of Positive Psychological Attitudes measures attitudes in different domains that can act as buffers to prevent stress and stress-related disorders. The 15 items measuring confidence during stress is used which measures one's ability to handle difficult times will be used. Item responses are scored on a 7-point scale ranging from 1 to 7 with a maximum total of 105 and a minimum of 7. Higher scores indicate greater resiliency.
Measured: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
Change in utilization of healthcare services
The Health Care Utilization measure was adapted from the Women's Health Care Experiences Survey. This measure was created as a self-report measure to capture women's use of different health care related services such as physical checkups, HIV screening, family planning services, abortion services, and other healthcare needs. For each different category of service, the measure asks if the service was used, where the service was received, if the service is available and why it was not used (if applicable). Each service is treated as a separate question, providing unique data; no scores are summed or averaged.
Measured: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
Change in severity and frequency of violence
The adapted version of the revised Conflict Tactics Scale (CTS) will be used to measure change in exposure to violence. The items on the CTS-2 are scored using the severity-times-frequency weighted score, as recommended by Straus (2004).
Measured: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
Change in physiological stress responses
Saliva samples are used to measure change in physiological stress response
Measured: Assessment time points, Baseline, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start10 Oct 2018
- Primary completion19 Feb 2022
- Study completion19 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ViolenceStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Bushra Sabri, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03664362
- Sponsor's protocol ID
- IRB00101882
- Other IDs
- K99HD082350, R00HD082350
- Acronym
- BSHAPE
- Status last verified
- May 2023
- First submitted
- 4 Sep 2018
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will only be available to the research team members of the project
Publications
Sabri B, Perrin N, Hagos M. The being safe, health and positively empowered pilot randomized controlled trial: A digital multicomponent intervention for immigrant women with cumulative exposures to violence. Cultur Divers Ethnic Minor Psychol. 2025 Apr;31(2):271-284. doi: 10.1037/cdp0000635. Epub 2024 Feb 8.
PubMed 38330368Sabri B, Vroegindewey A, Hagos M. Development, feasibility, acceptability and preliminary evaluation of the internet and mobile phone-based BSHAPE intervention for Immigrant survivors of cumulative trauma. Contemp Clin Trials. 2021 Nov;110:106591. doi: 10.1016/j.cct.2021.106591. Epub 2021 Oct 7.
PubMed 34626840
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cumulative Victimization and Women's Health Risks: Development of an Intervention
- ClinicalTrials.gov ID
- NCT03664362
- Acronym / sponsor ID
- BSHAPE / IRB00101882
- Conditions
- Violence, Cumulative Trauma, HIV Risk, Stress, Mental Health, Reproductive Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 19 Feb 2022 (actual)
- Study completion
- 19 Feb 2022 (actual)
- First posted
- 10 Sep 2018 (actual)
- 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.
The goal of the BSHAPE study is to test a trauma informed, culturally tailored, multicomponent program entitled BSHAPE (Being Safe, Healthy, And Positively Empowered) for immigrant survivors of cumulative trauma.
Detailed description
The central hypothesis is that the BSHAPE intervention will promote immigrant women's safety and health (e.g..,improved mental health, reduced physiological impact of stress and health inequities (especially reproductive-sexual health and HIV)), thus leading to overall empowerment.
The study will:
- Conduct a feasibility and acceptability evaluation of the BSHAPE intervention.
- Test the BSHAPE intervention for large scale implementation in community-based clinics and programs serving immigrant women.
The impact of BSHAPE will be evaluated in comparison to usual care in promoting safety and health outcomes among immigrant women with cumulative trauma experiences at post-intervention and at 6 and 12 months follow up.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The BSHAPE Intervention | Experimental | Behavioral: The BSHAPE InterventionParticipants in the BSHAPE intervention attend a 9 sessions program post-assessments which is a combination of individualized and group-based sessions. |
| Usual care or no treatment control | No intervention | –Participants in the control arm either are receiving no services or are engaged in usual care provided by community-based/health care organizations |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 18-55 years of age
- Self-identify as a female
- Born in Africa or foreign born from African descent
- Must have a current or past abusive romantic relationship
- Must be a survivor of cumulative trauma
Key exclusion criteria (6 listed)
- Less than 18 years of age or more than age 55
- Self-identify as a male
- Not African-born immigrant or born outside the US
- Is not a survivor of cumulative trauma
- Does not meet clinically significant criteria of PTSD and/or depression
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 |
|---|---|---|
| The BSHAPE InterventionThe BSHAPE intervention program key elements include strengths based assessments, individualized plans and support based on priorities and needs, motivational interviewing strategies, psychoeducation (education with skill building exercises), mindfulness activities, danger assessment, safety planning, behavioral activation and linkage to community resources | Behavioural | The BSHAPE Intervention |
Primary outcome
Change in depressive symptoms
Time frame: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
The Patient Health Questionnaire (PHQ-9) is a 9 item measure to assess depression symptoms based on the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual (DSM-IV). Each of the 9 items scores from 0 (not at all) to 3 (nearly every day).
Change in symptoms of post-traumatic stress disorder (PTSD)
Time frame: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
Harvard Trauma Questionnaire (16 items) is used to measure symptoms of PTSD derived from the DSM-IIR/DSM-IV criteria for PTSD. The scale for each question includes four categories of response: "Not at all," "A little," "Quite a bit," "Extremely," rated 1 to 4, respectively
Change in perceived stress
Time frame: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
The Perceived stress scale is a 10 item self-report measure of stress. It is designed to assess how stressed one feels in the past month. Item responses are rated on a 5-point scale ranging from 0 (Never) to 4 (Very often). Higher scores indicate higher perceived stress. This scale is scored by summing the answers to all items, for a highest score of 40. Scores 0-13 indicate low stress, 14-26 is moderate stress and 27-40 is considered high stress.
Change in sexual risk behaviors
Time frame: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)]
The Safe Sex Behavior Questionnaire is a 27-item self-report measure that describes sexual behaviors such as condom usage, sexual communication, and high-risk sexual behaviors. Item responses are rated on a 4-point scale ranging from 1 (Never) to 4 (Always). There are no subscales, and all items are summed to create a total score. Higher scores indicate engagement in safer sexual behaviors
Change in empowerment related to safety as assessed by the MOVERS scale
Time frame: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
The MOVERS is a 13 item scale that measures empowerment within the domain of safety. Participants respond to each item using a five-point scale from 1- "never true" to 5 - "always true". A maximum total of 65 and minimum of 13. Higher scores indicate higher level of empowerment related to safety.
9 secondary outcomes
Change in overall empowerment as assessed by the Personal Progress Scale-Revised
Time frame: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
Change in self-efficacy related to coping with trauma as assessed by the Trauma Coping Self-Efficacy scale
Time frame: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)]
Change in self-efficacy for HIV/Sexually Transmitted Infection (STI) prevention as assessed by the Self-Efficacy for STI-HIV Scale
Time frame: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
Change in HIV knowledge using the HIV Knowledge Questionnaire
Time frame: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
Change in Sexually Transmitted Disease (STD) knowledge using the STD Knowledge Questionnaire
Time frame: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
Change in attitudes for stress management as assessed by the Inventory of Positive Psychological Attitudes
Time frame: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
Change in utilization of healthcare services
Time frame: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
Change in severity and frequency of violence
Time frame: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)
Change in physiological stress responses
Time frame: Assessment time points, Baseline, 3 months and 6 months
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 26 May 2023.
- Derived from this study: PubMed 38330368Sabri B, Perrin N, Hagos M. The being safe, health and positively empowered pilot randomized controlled trial: A digital multicomponent intervention for immigrant women with cumulative exposures to violence. Cultur Divers Ethnic Minor Psychol. 2025 Apr;31(2):271-284. doi: 10.1037/cdp0000635. Epub 2024 Feb 8.
- Derived from this study: PubMed 34626840Sabri B, Vroegindewey A, Hagos M. Development, feasibility, acceptability and preliminary evaluation of the internet and mobile phone-based BSHAPE intervention for Immigrant survivors of cumulative trauma. Contemp Clin Trials. 2021 Nov;110:106591. doi: 10.1016/j.cct.2021.106591. Epub 2021 Oct 7.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will only be available to the research team members of the project
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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.
Bushra Sabri, PhD principal investigator
Johns Hopkins 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 The BSHAPE Intervention in people with Violence and Cumulative Trauma, run by Johns Hopkins 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 7 inclusion and 6 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 26 May 2023. 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 depressive symptoms (time frame: Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)). The study lists 5 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 NCT03664362, which also lists 2 linked publications.
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 26 May 2023; AzTrials last refreshed its copy on 8 Nov 2026.