- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05826041
Project INSPIRE: INtervention Support Groups: Peers Inspiring Resilience and Empowerment
February 21, 2024 updated by: Yale University
Development, Implementation and Evaluation of an Integrated, Peer-Led, Group Intervention for Survivors of Domestic Violence
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 Overview
Status
Terminated
Conditions
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Connecticut
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New Haven, Connecticut, United States, 06511
- Yale University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Domestic Violence Service Provider client referred for support group services
Exclusion Criteria:
- Unable to provide informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: INSPIRE Group
90-minute support group; 9 content sessions over 18 weeks; co-led by a professional facilitator and peer.
|
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.)
|
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Active Comparator: Intervention as Usual: Traditional Domestic Violence Support Group
75-minute support group; 18-weeks; led by a domestic violence service provider counselor or advocate
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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up to week 18
|
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Intervention acceptability/likability: Participant ratings of acceptability assessed using the Trauma-Informed Practices Scale (TIPS)
Time Frame: 9 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.
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9 weeks
|
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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.
|
18 weeks
|
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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
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up to week 18
|
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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.
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Baseline, 9 weeks, 18 weeks
|
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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.
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Baseline, 9 weeks, 18 weeks
|
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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.
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Baseline, 9 weeks, 18 weeks
|
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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.
|
Baseline, 9 weeks, 18 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Wellbeing assessed using the Quality of Life questionnaire
Time Frame: Baseline, 9 weeks, 18 weeks
|
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
|
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Change in Wellbeing assessed using the Rosenberg Self-Esteem Scale
Time Frame: Baseline, 9 weeks, 18 weeks
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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.
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Baseline, 9 weeks, 18 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tami P Sullivan, PhD, Department of Psychiatry, Yale School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 23, 2023
Primary Completion (Actual)
November 28, 2023
Study Completion (Actual)
November 28, 2023
Study Registration Dates
First Submitted
April 11, 2023
First Submitted That Met QC Criteria
April 11, 2023
First Posted (Actual)
April 24, 2023
Study Record Updates
Last Update Posted (Actual)
February 23, 2024
Last Update Submitted That Met QC Criteria
February 21, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2000024110
- 2018-SI-AX-0005 (Other Grant/Funding Number: Office on Violence Against Women (OVW))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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