Domestic ViolenceNCT05826041
Project INSPIRE: INtervention Support Groups: Peers Inspiring Resilience and Empowerment
A study testing (INSPIRE) INtervention Support groups: Peers Inspiring Resilience and Empowerment. and Traditional Domestic Violence Support Group in people with Domestic Violence, run by Yale University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Domestic Violence
- What is being tested?
- (INSPIRE) INtervention Support groups: Peers Inspiring Resilience and Empowerment. and Traditional Domestic Violence Support Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2023to 28 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Domestic Violence Service Provider client referred for support group services
Who cannot join
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Domestic Violence
- Being tested
- (INSPIRE) INtervention Support groups: Peers Inspiring Resilience and Empowerment., Traditional Domestic Violence Support Group
- Keywords
- Intimate Partner Violence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(INSPIRE) INtervention Support groups: Peers Inspiring Resilience and Empowerment.Behavioural
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 GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| INSPIRE Group | Experimental | 90-minute support group; 9 content sessions over 18 weeks; co-led by a professional facilitator and peer. Receives: 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 Receives: Behavioral: Traditional Domestic Violence Support Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 9 weeks, 18 weeks
Secondary outcomes (2)
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.
Measured: Baseline, 9 weeks, 18 weeks
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.
Measured: Baseline, 9 weeks, 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start23 Mar 2023
- Primary completion28 Nov 2023
- Study completion28 Nov 2023
Why it stopped: Site was unable to refer participants due to staffing issues post COVID
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Domestic ViolenceStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Other: INSPIRE support group Other: Intervention as usual
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tami P Sullivan, PhD, Principal investigator, Department of Psychiatry, Yale School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05826041
- Sponsor's protocol ID
- 2000024110
- Other IDs
- 2018-SI-AX-0005
- Status last verified
- Oct 2026
- First submitted
- 11 Apr 2023
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development, Implementation and Evaluation of an Integrated, Peer-Led, Group Intervention for Survivors of Domestic Violence
- ClinicalTrials.gov ID
- NCT05826041
- Acronym / sponsor ID
- 2000024110
- Conditions
- Domestic Violence
- Keywords
- Intimate Partner Violence
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Site was unable to refer participants due to staffing issues post COVID
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 23 Mar 2023 (actual)
- Primary completion
- 28 Nov 2023 (actual)
- Study completion
- 28 Nov 2023 (actual)
- First posted
- 24 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Other: INSPIRE support group Other: Intervention as usual
| Arm | Type | Receives |
|---|---|---|
| INSPIRE Group | Experimental | Behavioral: (INSPIRE) INtervention Support groups: Peers Inspiring Resilience and Empowerment.90-minute support group; 9 content sessions over 18 weeks; co-led by a professional facilitator and peer. |
| Intervention as Usual: Traditional Domestic Violence Support Group | Active comparator | Behavioral: Traditional Domestic Violence Support Group75-minute support group; 18-weeks; led by a domestic violence service provider counselor or advocate |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Domestic Violence Service Provider client referred for support group services
Key exclusion criteria (1 listed)
- Unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| (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.) | Behavioural | INSPIRE Group |
| Traditional Domestic Violence Support GroupThe 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. | Behavioural | Intervention as Usual: Traditional Domestic Violence Support Group |
Primary outcome
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.
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.
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 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.
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.
2 secondary outcomes
Change in Wellbeing assessed using the Quality of Life questionnaire
Time frame: Baseline, 9 weeks, 18 weeks
Change in Wellbeing assessed using the Rosenberg Self-Esteem Scale
Time frame: Baseline, 9 weeks, 18 weeks
Results and safety
The study was stopped early (reason given: Site was unable to refer participants due to staffing issues post COVID). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tami P Sullivan, PhD principal investigator
Department of Psychiatry, Yale School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing (INSPIRE) INtervention Support groups: Peers Inspiring Resilience and Empowerment. and Traditional Domestic Violence Support Group in people with Domestic Violence, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Site was unable to refer participants due to staffing issues post COVID). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention acceptability/likability: Participant ratings of group cohesion assessed using the Group Attitude Scale (GAS) (time frame: up to week 18). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.