Project INSPIRE: INtervention Support Groups: Peers Inspiring Resilience and Empowerment

NCT05826041 | Terminated

• 2 other identifiers: 20000241102018-SI-AX-0005
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Domestic Violence

Keywords

Intimate Partner Violence

Outcome Measures

Primary Outcomes (8)

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

  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.

  up to week 18

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

  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.

  9 weeks

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

  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.

  18 weeks

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

  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

  up to week 18

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

  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.

  Baseline, 9 weeks, 18 weeks

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

  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.

  Baseline, 9 weeks, 18 weeks

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

  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.

  Baseline, 9 weeks, 18 weeks

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

  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.

  Baseline, 9 weeks, 18 weeks

Secondary Outcomes (2)

• Change in Wellbeing assessed using the Quality of Life questionnaire

  Baseline, 9 weeks, 18 weeks

• Change in Wellbeing assessed using the Rosenberg Self-Esteem Scale

  Baseline, 9 weeks, 18 weeks

Study Arms (2)

INSPIRE Group

EXPERIMENTAL

90-minute support group; 9 content sessions over 18 weeks; co-led by a professional facilitator and peer.

Behavioral: (INSPIRE) INtervention Support groups: Peers Inspiring Resilience and Empowerment.

Intervention as Usual: Traditional Domestic Violence Support Group

ACTIVE COMPARATOR

75-minute support group; 18-weeks; led by a domestic violence service provider counselor or advocate

Behavioral: Traditional Domestic Violence Support Group

Interventions

(INSPIRE) INtervention Support groups: Peers Inspiring Resilience and Empowerment. BEHAVIORAL

The support group contains both structured components, which are psychoeducational and focused on skill-building, and an unstructured component where discussion is open and determined by the needs and interests of the clients present (e.g., support and process-oriented.)

INSPIRE Group

Traditional Domestic Violence Support Group BEHAVIORAL

The activities of the group are determined by agency staff from week to week and may be open group discussion, psychoeducation, or a combination of both.

Intervention as Usual: Traditional Domestic Violence Support Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Domestic Violence Service Provider client referred for support group services

You may not qualify if:

• Unable to provide informed consent

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale University

New Haven, Connecticut, 06511, United States

Location

Study Officials

• Tami P Sullivan, PhD

  Department of Psychiatry, Yale School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Other: INSPIRE support group Other: Intervention as usual

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: April 24, 2023
• Study Start: March 23, 2023
• Primary Completion: November 28, 2023
• Study Completion: November 28, 2023
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)