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

Domestic Violence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05826041
• Other study ID #: 2000024110
• Secondary ID: 2018-SI-AX-0005
• Status: Terminated
• Phase: N/A
• Start date: March 23, 2023
• Est. completion date: November 28, 2023

Study information

• Verified date: February 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: November 28, 2023
• Est. primary completion date: November 28, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Domestic Violence Service Provider client referred for support group services

Exclusion Criteria:

• Unable to provide informed consent

Related Conditions & MeSH terms

• Domestic Violence

Intervention

Behavioral:
• (INSPIRE) INtervention Support groups: Peers Inspiring Resilience and Empowerment.
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.)
• Traditional Domestic Violence Support Group
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.

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Change in Wellbeing assessed using the Quality of Life questionnaire	Change in Wellbeing will be assessed using the Quality of Life questionnaire. The 9 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 wellbeing.	Baseline, 9 weeks, 18 weeks
Secondary	Change in Wellbeing assessed using the Rosenberg Self-Esteem Scale	Change in Wellbeing will be assessed using the Rosenberg Self-Esteem Scale. The 10-item scale ranges from 0-30. Scores between 15 and 25 are within normal range; scores below 15 suggest low self-esteem.	Baseline, 9 weeks, 18 weeks