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

NCT03664362 | Completed DMC

• 3 other identifiers: IRB00101882K99HD082350R00HD082350
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Violence; Cumulative Trauma; HIV Risk; Stress; Mental Health; Reproductive Health; Empowerment

Outcome Measures

Primary Outcomes (5)

• 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).

  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

  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.

  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

  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.

  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

  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

  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

  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

  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

  Through study completion, an average of 1 year (Assessment time points: Baseline, 3 months, 6 months, 12 months)

Study Arms (2)

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.

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

Interventions

The BSHAPE Intervention BEHAVIORAL

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

The BSHAPE Intervention

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: If identify as biologically female or transgender female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Related Publications (2)

• 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.

  PMID: 38330368 DERIVED

• Sabri 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.

  PMID: 34626840 DERIVED

MeSH Terms

Conditions

Psychological Well-Being; Empowerment

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Social Behavior

Study Officials

• Bushra Sabri, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 10, 2018
• Study Start: October 10, 2018
• Primary Completion: February 19, 2022
• Study Completion: February 19, 2022
• Last Updated: May 26, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• 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

Locations

US (1)