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The BSHAPE Intervention Program for Safety and Health of Survivors of Cumulative Trauma (BSHAPE)

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ClinicalTrials.gov Identifier: NCT03664362
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief 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.

Condition or disease Intervention/treatment Phase
Violence Cumulative Trauma HIV Risk Stress Mental Health Reproductive Health Empowerment Behavioral: The BSHAPE Intervention Not Applicable

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:

  1. Conduct a feasibility and acceptability evaluation of the BSHAPE intervention.
  2. 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Cumulative Victimization and Women's Health Risks: Development of an Intervention
Actual Study Start Date : October 10, 2018
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2020

Arm Intervention/treatment
Experimental: The BSHAPE Intervention
Participants in the BSHAPE intervention attend a 9 sessions program post-assessments which is a combination of individualized and group-based sessions.
Behavioral: The BSHAPE Intervention
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

No Intervention: Usual care or no treatment control
Participants in the control arm either are receiving no services or are engaged in usual care provided by community-based/health care organizations



Primary Outcome Measures :
  1. 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).

  2. 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

  3. 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.

  4. 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) ]
    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).

  5. 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

  6. Change in physiological stress responses [ Time Frame: Assessment time points, Baseline, 3 months and 6 months ]
    Saliva samples are used to measure change in physiological stress response


Secondary Outcome Measures :
  1. 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) ]
    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.

  2. 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.

  3. 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)] ]
    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.

  4. 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) ]
    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.

  5. 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) ]
    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.

  6. 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) ]
    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.

  7. 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) ]
    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.

  8. 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) ]
    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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   If identify as biologically female or transgender female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-50 years of age
  • Self-identify as a female
  • Born in Africa
  • 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

Exclusion Criteria:

  • Less than 18 years of age or more than age 50
  • Self-identify as a male
  • Not African-born immigrant
  • Is not a survivor of intimate partner violence
  • 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

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): NCT03664362


Contacts
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Contact: Bushra Sabri, MSW, PhD 410-955-7105 bsabri1@jhu.edu

Locations
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United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21205
Contact: Bushra Sabri, MSW, PhD         
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Bushra Sabri, PhD Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03664362     History of Changes
Other Study ID Numbers: IRB00101882
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will only be available to the research team members of the project
Time Frame: Data will only be available for the duration of the project and one year after completion
Access Criteria: The de-identified data will only be shared on a secure encrypted website that is managed by Johns Hopkins University

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No