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Clinical Trials/NCT05826041
NCT05826041TerminatedNot Applicable

Development, Implementation and Evaluation of an Integrated, Peer-Led, Group Intervention for Survivors of Domestic Violence

Yale University2 sites in 1 country9 target enrollmentStarted: March 23, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
9
Locations
2
Primary Endpoint
Intervention acceptability/likability: Participant ratings of acceptability assessed using the Trauma-Informed Practices Scale (TIPS)

Study Overview

Brief Summary

The investigators will develop a new, integrated, group intervention to enhance safety, support, and empowerment for survivors of intimate partner violence in the community. The intervention will consist of 9 weekly, 90-minute group sessions that will teach specific skills for identifying various forms of trauma and abuse, developing mutually supportive relationships, safety planning and self-care, goal-oriented communication, empowerment and self-efficacy, goal setting, coping, and connecting to resources. The investigators will pilot test the intervention, including evaluating the process of implementation, including feasibility, acceptability/likeability, and safety, as well as evaluating outcomes of safety, support, and empowerment. Outcomes from the intervention will be compared to outcomes from a traditional domestic violence support group.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Domestic Violence Service Provider client referred for support group services

Exclusion Criteria

  • Unable to provide informed consent

Outcomes

Primary Outcomes

Intervention acceptability/likability: Participant ratings of acceptability assessed using the Trauma-Informed Practices Scale (TIPS)

Time Frame: 18 weeks

Acceptability will be assessed using the Trauma-Informed Practices Scale (TIPS). TIPS is a 33-item self-report measure comprised of 6 subscales. This study will use 28 of the original 33 items representing 5 of the 6 subscales: agency, information, connection, strengths, and cultural responsiveness and inclusivity; the support for parenting subscale was excluded as the intervention is not designed specifically to support parents. Items are rated on a 0-3 Likert scale, and mean scores are computed for each subscale and overall scale. Scores range from 0-3, with higher scores representing perceived receipt of more trauma-informed services.

Intervention acceptability/likability: Participant ratings of group cohesion assessed using the Group Attitude Scale (GAS)

Time Frame: up to week 18

Group cohesion will be assessed weekly by a modified version of the GAS. The 20 items are rated on a 1-5 Likert scale. A total score is computed by averaging the items. Scores range from 1-5, with higher scores indicating more group cohesion.

Change in support assessed using the Domestic Violence Resource Utilization (DVR) questionnaire

Time Frame: Baseline, 9 weeks, 18 weeks

Change in support will be assessed using the DVR questionnaire. The 24 items represent various types of services/resources used, and a count variable (0-24) is computed to indicate the total number of different kinds of services/resources an individual use.

Change in social support assessed using the Medical Outcomes Study Social Support (MOS-SS) Survey

Time Frame: Baseline, 9 weeks, 18 weeks

Change in support will be assessed using the MOS-SS Survey. The 19 items are rated on a 5-point Likert scale. Mean scores are computed for each of the four subscales (emotional/informational support, tangible support, affectionate support, and positive social interaction), and a total summary score. Scores range from 1-5, with higher scores indicating greater levels of support.

Change in empowerment assessed using the Personal Progress Scale - Revised (PPS-R)

Time Frame: Baseline, 9 weeks, 18 weeks

Change in empowerment will be assessed using the PPS-R. The 28 items are rated on a 7-point Likert scale, and a total score is computed by averaging the items; total scores range from 1-7, with higher scores indicating higher levels of empowerment.

Intervention acceptability/likability: Participant ratings of Working alliance assessed using the Session Rating Scale (SRS)

Time Frame: up to week 18

Working alliance will be measured using an adapted version of the SRS. The SRS is a 4-item visual analog instrument. Each item is assessed using a 0-10 point scale. This measure will be modified for the participant to rate the working alliance with the peer co-facilitator and professional co-facilitator separately, for a total of 6 questions. A total score is computed by summing each item. Scores will range from 0-60, with an overall score of less than 56, or 9 on any item, indicating potential concerns in working alliance

Change in safety-related empowerment assessed using the Measure of Victim Empowerment Related to Safety (MOVERS) Scale

Time Frame: Baseline, 9 weeks, 18 weeks

Change in safety-related empowerment will be assessed using the Expectation of Support and Internal Tools subscales of the MOVERS Scale. Items are rated on a 1-5 Likert scale. Items corresponding to each subscale are averaged. Scores range from 1-5, with higher scores indicating higher levels of safety-related empowerment.

Secondary Outcomes

  • Change in Wellbeing assessed using the Rosenberg Self-Esteem Scale(Baseline, 9 weeks, 18 weeks)
  • Change in Wellbeing assessed using the Quality of Life questionnaire(Baseline, 9 weeks, 18 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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