- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07277816
Photo-experiencing and Reflective Listening (PEARL) to Promote Healing Engagement for Survivors of Violence
Photo-experiencing and Reflective Listening (PEARL) to Promote Healing Engagement for Survivors of Violence: A Feasibility Study
The goal of this clinical trial is to learn if a photo-elicitation intervention called PEARL (Photo-experiencing and Reflective Listening) can promote healing engagement in survivors of interpersonal violence. It will also learn about the feasibility and acceptability of PEARL. The main questions it aims to answer are:
Does PEARL reduce barriers to help-seeking for trauma? Does PEARL improve trauma coping self-efficacy? Does PEARL change post-trauma cognitions and readiness for recovery? Is PEARL feasible and acceptable to survivors of interpersonal violence?
Researchers will compare people who receive PEARL immediately to people on a waitlist (who receive PEARL three months later) to see if PEARL improves healing engagement and help-seeking behaviors.
Participants will:
- Complete baseline surveys about their trauma history, mental health, healing, and help-seeking behaviors
- Be randomly assigned to receive PEARL immediately or after a 3-month wait
- Receive a photography-focusing prompt and create photos over two weeks (those in the immediate group or after the waiting period)
- Participate in a reflective listening interview about their photos
- Complete follow-up surveys immediately after the intervention and one month later
- Participate in a one-month follow-up interview about their experience
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a randomized waitlist control feasibility study of the PEARL (Photo-experiencing and Reflective Listening) intervention for women survivors of interpersonal violence. The study will enroll 40 participants recruited through local community organizations, interpersonal violence email listservs, and social media platforms.
Randomization and Study Arms:
Interested participants will complete an online baseline questionnaire through Qualtrics and be randomly assigned (1:1) to either:
- Immediate Intervention Group (n=20): Receives PEARL within two weeks of enrollment
- Waitlist Control Group (n=20): Receives a resource referral list (standard of care) and completes PEARL three months later
Intervention Protocol:
The PEARL intervention consists of two components:
- Participants receive a photography-focusing prompt and have two weeks to create photographs
- Participants complete a reflective listening interview about their photographs
Assessment Schedule:
- Baseline: Demographics, trauma history, and outcome measures
- Post-intervention: Outcome measures completed immediately after the intervention (trauma coping self-efficacy, post trauma cognitions, healing)
- One-month follow-up: Outcome measures and qualitative interview (trauma coping self-efficacy, post trauma cognitions, healing, help-seeking actions, depression, anxiety, PTSD).
The waitlist control group completes an additional baseline survey three months after initial enrollment, which serves as their pre-intervention assessment.
Data Analysis: Feasibility will be assessed through completion rates, and research assistant evaluations. Acceptability will be evaluated through participant surveys and follow-up interviews. Preliminary impact on healing engagement and help-seeking will be analyzed using descriptive statistics and nonparametric tests. Qualitative data from open-ended survey questions, research assistant evaluations, and follow-up interviews will undergo thematic analysis. Quantitative and qualitative findings will be integrated to provide a comprehensive understanding of PEARL's feasibility, acceptability, and potential impact.
Community Engagement: The study incorporates feedback from Community Advisory Board (CAB) and Scientific Advisory Board (SAB) members throughout the research process. Purposive sampling strategies will be employed to achieve maximum diversity in participant age.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Laura M Sinko, PhD, MSHP, RN
- Phone Number: 9732140617
- Email: laura.sinko@temple.edu
Study Contact Backup
- Name: Kayleigh Izzo, BS
- Phone Number: 6105501648
- Email: kayleigh.izzo@temple.edu
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19122
- Recruiting
- Women in Transition
-
Contact:
- Melissa McDermott, MSW
- Email: MMcDermott@helpwomen.org
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18 years or older
- History of interpersonal violence (IV) - identifies as a survivor of interpersonal violence
- Able to complete an interview in English
- Able to provide informed consent
Exclusion Criteria:
- Under 18 years of age
- Does not identify as a woman (male participants excluded)
- No history of interpersonal violence
- Unable to complete an interview in English
- Unable to provide informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Immediate Intervention Group
Participants randomized to this arm receive the PEARL intervention within two weeks of enrollment.
They are given a photography-focusing prompt and two weeks to create photographs reflecting their healing journey.
After two weeks, they participate in a reflective listening interview about their photographs.
Participants complete surveys at baseline, immediately post-intervention, and at one-month follow-up, as well as a qualitative interview at one-month follow-up.
|
PEARL is a two-component behavioral intervention designed to promote healing engagement among survivors of interpersonal violence.
Participants receive a photography-focusing prompt and are given two weeks to create photographs that reflect their healing journey and experiences.
After the two-week photography period, participants engage in a one-on-one reflective listening interview where they discuss the photographs they created and co-create a healing action plan based on these discussions.
The interview provides a structured opportunity for participants to explore and articulate their healing process through photo-elicitation, allowing them to express their experiences visually and verbally.
The intervention is delivered by trained research assistants with fidelity monitoring through audio recording and independent evaluation of a random sample of sessions.
Other Names:
|
|
Active Comparator: Waitlist Control Group
Participants randomized to this arm receive a resource referral list (standard of care) and wait three months before receiving the PEARL intervention.
They complete baseline surveys at enrollment and again at three months (pre-intervention baseline).
After the three-month waiting period, they receive the same PEARL intervention as the immediate group: a photography-focusing prompt, two weeks to create photographs, and a reflective listening interview.
They complete post-intervention and one-month follow-up assessments following their intervention.
|
PEARL is a two-component behavioral intervention designed to promote healing engagement among survivors of interpersonal violence.
Participants receive a photography-focusing prompt and are given two weeks to create photographs that reflect their healing journey and experiences.
After the two-week photography period, participants engage in a one-on-one reflective listening interview where they discuss the photographs they created and co-create a healing action plan based on these discussions.
The interview provides a structured opportunity for participants to explore and articulate their healing process through photo-elicitation, allowing them to express their experiences visually and verbally.
The intervention is delivered by trained research assistants with fidelity monitoring through audio recording and independent evaluation of a random sample of sessions.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Healing after Gender-based Violence Scale
Time Frame: Baseline, immediately post-intervention (approximately 2-4 weeks after baseline), and 1-month follow-up (approximately 6-8 weeks after baseline)
|
This 18-item scale measures holistic healing after trauma.
Items are rated on a 5-point Likert scale from 1 ('Not at all') to 5 ('To a great extent').
Respondents are asked to evaluate each statement in reference to their perceived lowest point and their current feelings.
This measure captures holistic healing outcomes beyond symptom reduction.
Higher scores indicate greater levels of healing.
|
Baseline, immediately post-intervention (approximately 2-4 weeks after baseline), and 1-month follow-up (approximately 6-8 weeks after baseline)
|
|
Post-trauma Cognitions Inventory (PTCI)
Time Frame: Baseline, immediately post-intervention (approximately 2-4 weeks after baseline), and 1-month follow-up (approximately 6-8 weeks after baseline)
|
The PTCI is a self-report measure used to assess posttraumatic cognitions.
It is composed of three subscales: Negative Cognitions about the Self, Negative Cognitions about the World, and Self-Blame.
Higher scores indicate more negative trauma-related cognitions.
The minimum score one can receive is 33 and the maximum score is 231.
|
Baseline, immediately post-intervention (approximately 2-4 weeks after baseline), and 1-month follow-up (approximately 6-8 weeks after baseline)
|
|
Trauma Coping Self-efficacy Scale
Time Frame: Baseline, immediately post-intervention (approximately 2-4 weeks after baseline), and 1-month follow-up (approximately 6-8 weeks after baseline)
|
The Trauma Coping Self-efficacy Scale is a 7-item measure that covers trauma-related coping self-efficacy including: dealing with reminders of the event, dealing with emotions associated with the event, employing active coping strategies, and resuming normal functioning.
Higher scores indicate greater confidence in ability to cope with trauma.
The minimum score one can receive is 0 and the maximum score is 63.
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Baseline, immediately post-intervention (approximately 2-4 weeks after baseline), and 1-month follow-up (approximately 6-8 weeks after baseline)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PTSD Checklist for DSM-5 (PCL-5)
Time Frame: Baseline and 1-month follow-up (approximately 6-8 weeks after baseline)
|
The PCL-5 is a 20-item self-report measure that assesses the presence and severity of PTSD symptoms according to DSM-5 criteria.
Response options are on a 5-point Likert scale with anchors: 0 = not at all, 4 = extremely.
Items assess intrusion symptoms, avoidance, negative alterations in cognitions and mood, and alterations in arousal and reactivity.
A total symptom severity score (range 0-80) can be obtained by summing the scores for each of the 20 items.
A score of 33 is the current clinical cut-off for probable PTSD.
|
Baseline and 1-month follow-up (approximately 6-8 weeks after baseline)
|
|
Patient Health Questionnaire-8 (PHQ-8)
Time Frame: Baseline and 1-month follow-up (approximately 6-8 weeks after baseline)
|
The PHQ-8 is an eight-item, self-administered scale based on DSM-IV diagnostic criteria for major depression, identical to the PHQ-9 but without the suicide item.
Each item is scored on a four-point scale with responses ranging from 0 (not at all) to 3 (nearly every day), assessing depression symptom frequency over the past two weeks.
Total scores range from 0-24.
A PHQ-8 score of 10 or more has been found to have 88% sensitivity and 88% specificity for diagnosis of major depression based on clinical interview.
This measure captures depression as a healing outcome related to symptom reduction.
|
Baseline and 1-month follow-up (approximately 6-8 weeks after baseline)
|
|
Generalized Anxiety Disorder-7 (GAD-7)
Time Frame: Baseline and 1-month follow-up (approximately 6-8 weeks after baseline)
|
The GAD-7 is a 7-item self-report questionnaire for screening and measuring the severity of generalized anxiety disorder.
Response options are identical to the PHQ-8, with items scored from 0 (not at all) to 3 (nearly every day), assessing anxiety symptom frequency over the past two weeks.
Total scores range from 0 to 21, with scores of ≥5, ≥10, and ≥15 representing mild, moderate, and severe anxiety symptom levels, respectively.
This measure captures anxiety as a healing outcome related to symptom reduction.
|
Baseline and 1-month follow-up (approximately 6-8 weeks after baseline)
|
|
Trauma Recovery Actions Checklist (TRAC)
Time Frame: Baseline and 1-month follow-up (approximately 6-8 weeks after baseline)
|
The TRAC is a 35-item checklist of recovery actions that participants are currently using, want to use, or do not want to use.
The checklist provides a comprehensive assessment of various recovery strategies and actions.
Subscales include: building positive emotions, sharing and connecting with others, reflecting and creating healing spaces, establishing security, and futuring (planning for the future).
This measure captures the range of recovery actions participants are taking or considering to support their healing journey.
|
Baseline and 1-month follow-up (approximately 6-8 weeks after baseline)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Laura Sinko, PhD, MSHP, RN, Temple University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 272926
- 5K01NR021275-02 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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