- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06375876
Single Session Intervention to Promote Hope
Hope as a Path to Healing: Developing a Single-Session Intervention for Women Who Experience Intimate Partner Violence
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study aims to accomplish two primary objectives: Objective 1 (Intervention Development Stage): Develop a brief, self-guided SSI to enhance hope and in turn, self-worth, empowerment, and emotional wellbeing, and Objective 2 (Pilot Stage): Pilot test the intervention and evaluate the process of implementation and primary outcomes of feasibility, acceptability/likability, and safety; and to assess changes in hope and secondary outcomes of self-worth, empowerment, and emotional wellbeing.
The Pilot Stage will utilize micro-longitudinal methods (i.e., daily self-reports of hope, self-worth, empowerment, and emotional wellbeing for 14 days before and after the intervention) to assess changes in these constructs. Eligible participants will take part in a baseline interview with a member of the research team. Baseline measures will be based on participant self-report and used to characterize the sample and collect data on person-level control variables. Beginning the day after the baseline interview, participants will complete a brief daily survey on their smartphone. On day 15, participants will receive a link to the SSI and be asked to complete it that day; immediately following the SSI, participants will be asked to complete the post-intervention survey/process supplement to aid in the process evaluation. After completion of the SSI, survivors will participate in 14 additional days of daily data collection to establish post-intervention outcome measures.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Connecticut
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New Haven, Connecticut, United States, 06511
- The Consultation Center at Yale
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Pilot Stage:
- Self-identify as a woman (cis- or trans-gender woman)
- Currently in a relationship of at least 3 months duration in which they have experienced physical IPV by a male partner
- Have a smartphone that is compatible with the MyCap app to be able to participate in daily surveys.
Exclusion Criteria:
Pilot Stage:
- Have experienced significant psychiatric instability based on self-reported inpatient psychiatric hospitalization in the past 3 months
- Reports having a conservator of person
- Not comfortable conversing, reading, or writing in English
- Participated in a Listening Session in the development phase of this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Single-Session Intervention to Promote Hope
A 30-45 minute self-guided intervention delivered in a web browser.
|
The SSI focuses on increasing hope among women who experience IPV using facts about the brain and IPV research, stories from survivors, and writing exercises.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility assessed by percent enrolled
Time Frame: up to one month
|
The percent of women enrolled in the study who complete the SSI and individual SSI components.
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up to one month
|
|
Feasibility assessed by time to complete
Time Frame: up to one month
|
How long it took a participant to complete the intervention (in minutes), and if it was done in more than one setting.
|
up to one month
|
|
Feasibility assessed by post-intervention survey/process supplement
Time Frame: up to one month
|
Feasibility will also be assessed in the post-intervention survey/process supplement by asking women 1) where they completed the program, 2) if they listened to the program's read aloud options, and 3) an open-response question about factors that influenced where and when they completed the program since little is known about factors that participation in an intervention of this nature.
|
up to one month
|
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Acceptability/likability assessed using the Program Feeback Scale
Time Frame: up to one month
|
The Program Feedback Scale asks participant to rate seven statements regarding intervention acceptability and feasibility; it also includes open-response items that invite participants to share what they liked and/or would change about the intervention.
The seven statements are rated from 0 (Strongly Disagree) to 5 (Strongly Agree).
Total scores range from 0 to 36, with higher scores indicating a more positive evaluation.
|
up to one month
|
|
Safety assessed using end of study survey
Time Frame: up to one month
|
Participants will be asked if completing the intervention caused any problems for them and their partner that made them feel unsafe; participants responding in the affirmative will be asked to elaborate in a follow-up open-response question.
|
up to one month
|
|
Change in Hope assessed using Herth Hope Index
Time Frame: baseline (pre intervention) and up to one month (post intervention)
|
Change in hope will be assessed with daily data using 5 items from the HHI that measure 3 dimensions of hope: 2 items from the temporality and future/cognitive-temporal subscale, 1 item from the positive readiness and expectancy subscale, and 2 items from the interconnectedness subscale.
Items are rated from 0 (Strongly Disagree) to 5 (Strongly Agree) with higher values indicating more hope
|
baseline (pre intervention) and up to one month (post intervention)
|
|
Change in Hope assessed using Trait Hope Scale
Time Frame: baseline (pre intervention) and up to one month (post intervention)
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Change in hope will be assessed with daily data using 2 items from the Trait Hope Scale; 1 item from the agency subscale and 1 item from the pathway subscale.
Items are rated from 0 (Strongly Disagree) to 5 (Strongly Agree), with higher values indicating more hope
|
baseline (pre intervention) and up to one month (post intervention)
|
|
Change in Hope assessed using Beck Hopelessness Scale (single item)
Time Frame: baseline (pre intervention) and up to one month (post intervention)
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Hopelessness will be assessed with daily data using 1 item from the Beck Hopelessness Scale.
The item is rated on a scale from 0 'Strongly disagree' to 5 'Strongly agree' with higher values indicating higher levels of hopelessness.
|
baseline (pre intervention) and up to one month (post intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Self-worth
Time Frame: baseline (pre intervention) and up to one month (post intervention)
|
Change in self-worth will be assessed with daily data using 1 item from the self-esteem/self-efficacy subscale of the Making Decisions and Empowerment Measure.
The item is rated on a scale from 0 (Strongly Disagree) to 5 (Strongly Agree).
|
baseline (pre intervention) and up to one month (post intervention)
|
|
Change in Empowerment assessed using The Personal Progress Scale-Revised (PPS-R)
Time Frame: baseline (pre intervention) and up to one month (post intervention)
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Changes in empowerment will be assessed with daily data using 2 items from the Personal Progress Scale-Revised.
Items are rated on a scale from 0 (Strongly Disagree) to 5 (Strongly Agree).
The two items are summed; Scores range from 0-10 with higher scores indicating higher levels of empowerment
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baseline (pre intervention) and up to one month (post intervention)
|
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Change in Emotional wellbeing measured by the Patient Health Questionnaire-2 (PHQ-2)
Time Frame: baseline (pre intervention) and up to one month (post intervention)
|
Changes in emotional wellbeing will be assessed with daily data using the PHQ-2.
The two items are rated on a scale from 0 (Not at all) to 3 (Nearly the entire day) and summed, with scores ranging from 0-6, with higher scores indicating higher prevalence depressive symptoms.
|
baseline (pre intervention) and up to one month (post intervention)
|
|
Change in Emotional wellbeing measured by the State Joy Scale
Time Frame: baseline (pre intervention) and up to one month (post intervention)
|
Changes in emotional wellbeing will be assessed with daily data using 1 item from the State Joy Scale.
The item is rated on a on a scale from 0 (Not at all) to 3 (Nearly the entire day) with higher values indicating higher prevalence of joy.
|
baseline (pre intervention) and up to one month (post intervention)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Tami Sullivan, PhD, Department of Psychiatry, Yale School of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2000034173
- 15JOVW-22-GG-04755-STOP (Other Grant/Funding Number: Office on Violence Against Women (OVW))
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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