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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Yale University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: INSPIRE Group
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.
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.)
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
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
up to week 18
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.
9 weeks
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
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
up to week 18
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.
Baseline, 9 weeks, 18 weeks
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.
Baseline, 9 weeks, 18 weeks
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.
Baseline, 9 weeks, 18 weeks
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Change in Wellbeing assessed using the Rosenberg Self-Esteem Scale
Time Frame: Baseline, 9 weeks, 18 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 23, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 28, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 28, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 11, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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