Clinical trial NCT06375876: Single Session Intervention to Promote Hope
Official title: Hope as a Path to Healing: Developing a Single-Session Intervention for Women Who Experience Intimate Partner Violence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Domestic Violence
Keywords: Intimate Partner Violence (IPV)
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Office on Violence Against Women (OVW)
name: Center for Family Justice
name: Connecticut Coalition Against Domestic Violence
First posted: 2024-04-19
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to develop a brief, self-guided single-session intervention (SSI) that targets the development of, or increase in, hope, and pilot test it for the primary outcomes of feasibility, acceptability/likeability, safety, and changes in hope, and the secondary outcomes of self-worth, empowerment, and emotional wellbeing among women experiencing intimate partner violence (IPV). The study will be conducted in 2 stages: intervention development (Intervention Development Stage), and pilot testing the intervention (Pilot Stage). The focus of this registration is the Pilot Stage.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility assessed by percent enrolled
timeFrame: up to one month
measure: Feasibility assessed by time to complete
timeFrame: up to one month
measure: Feasibility assessed by post-intervention survey/process supplement
timeFrame: up to one month
measure: Acceptability/likability assessed using the Program Feeback Scale
timeFrame: up to one month
measure: Safety assessed using end of study survey
timeFrame: up to one month
measure: Change in Hope assessed using Herth Hope Index
timeFrame: baseline (pre intervention) and up to one month (post intervention)
measure: Change in Hope assessed using Trait Hope Scale
timeFrame: baseline (pre intervention) and up to one month (post intervention)
measure: Change in Hope assessed using Beck Hopelessness Scale (single item)
timeFrame: baseline (pre intervention) and up to one month (post intervention)
Secondary outcomes:
measure: Change in Self-worth
timeFrame: baseline (pre intervention) and up to one month (post intervention)
measure: Change in Empowerment assessed using The Personal Progress Scale-Revised (PPS-R)
timeFrame: baseline (pre intervention) and up to one month (post intervention)
measure: Change in Emotional wellbeing measured by the Patient Health Questionnaire-2 (PHQ-2)
timeFrame: baseline (pre intervention) and up to one month (post intervention)
measure: Change in Emotional wellbeing measured by the State Joy Scale
timeFrame: baseline (pre intervention) and up to one month (post intervention)
Other outcomes:
Locations:
city: New Haven
country: United States
facility: The Consultation Center at Yale
state: Connecticut
Study officials:
affiliation: Department of Psychiatry, Yale School of Medicine
name: Tami Sullivan, PhD
role: PRINCIPAL_INVESTIGATOR
References: