Intimate Partner ViolenceNCT06071299
Impact of Family-Centered Care for Intimate Partner Violence (IPV)
A study testing FCC and CCC in people with Intimate Partner Violence, run by Yale University at 2 sites in United States.
Trial summary
The purpose of the study will be to determine how participation in Family-Centered Care (FCC) compared to Child-centered care (CCC) will affect caregiver engagement in IPV-based community services, caregiver perceptions of empowerment and survivor-defined practice, and clinical outcomes for children exposed to IPV. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intimate Partner Violence
- What is being tested?
- FCC and CCC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Jan 2024to 15 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Have a child < 5-years-old who been reported to Child Protectives Services for IPV exposure
- Parent > 18 years old who has agreed to a medical evaluation for the child at the child advocacy center
- Does not already have a connection to an IPV advocate
- Able to speak English or Spanish fluently
- Not a ward of department of children and families
Who cannot join
- Ward of the state
- Language preference other than English or Spanish
Trial locations and contacts
2 sites in 1 country.
United States2 sites
SCAN Clinic
Hartford, Connecticut, 06106
The South Central Child Advocacy Center
New Haven, Connecticut, 06520
About this study
The purpose of the study will be to determine how participation in Family-Centered Care (FCC) compared to Child-centered care (CCC) will affect caregiver engagement in IPV-based community services, caregiver perceptions of empowerment and survivor-defined practice, and clinical outcomes for children exposed to IPV.
Read the detailed description
The study population includes victims of intimate partner violence whose children < 5-years old have been referred to Child Protective Services due to exposure to IPV and who have agreed to a medical evaluation for the child(ren) in the child advocacy center or the SCAN clinic and don't already have a connection to an IPV advocate. The study population will include adults who are primarily English or Spanish Language preferring. For professionals, the target audience will be local CPS investigators in the New Haven and Hartford CPS office, IPV advocates at the New Haven Umbrella Center for Intimate Partner Violence Services and The Hartford Interval House and child abuse pediatricians at Yale University School of Medicine and at the Connecticut Childrens Medical Center.
- Conditions
- Intimate Partner Violence
- Being tested
- FCC, CCC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FCCBehavioural
Children evaluated for abusive injuries. Caregiver offered meeting with IPV advocate during visit (survivor-centered care, immediate access to services; continued engagement with advocate for ongoing needs). Referral to Child-Study center for trauma follow up. Connection to pediatrician. Use of motivational interviewing to address IPV.
CCCBehavioural
Children evaluated for abusive injuries. Medical provider offers IPV resources to caregiver. Referral to Child-Study center for trauma follow up. Connection to pediatrician. Use of motivational interviewing to address IPV.
| Study group | Role | What they receive |
|---|---|---|
| FCC model | Experimental | Participants will receive family-focused care. Receives: Behavioral: FCC |
| CCC model | Active comparator | Participants will receive the usual child-focused care. Receives: Behavioral: CCC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of caregivers with follow-up visits with an IPV advocate
Percentage of caregivers who have at least one follow-up visit with an IPV advocate by 3 months after the initial visit by self-report.
Measured: up to 3 months post visit 1
Secondary outcomes (6)
Percentage of evaluated children who complete a skeletal survey
Percentage of evaluated children <1 yr who complete a skeletal survey up to 4 weeks after the initial visit.
Measured: up to 4 weeks post visit 1
Perceptions of survivor-defined practice using the Survivor Defined Practice Scale (SDPS)
The SDPS is a nine-item measure that assesses intimate partner violence survivors' perception of the degree to which their advocates help them achieve goals they set for themselves, facilitate a spirit of partnership, and show sensitivity to their individual needs and styles. Items are scored on a scale of 1-4 (strongly disagree to strongly agree). Total score range of 9-36. Higher scores indicate a better perception of advocates help.
Measured: up to 4 weeks post visit 1
Perceptions of safety-related empowerment using the Measure of Victim Empowerment Related to Safety (MOVERS) scale.
MOVERS is a 13-item scale that measures survivor empowerment within the domain of safety. MOVERS is composed of three subscales that assess distinct domains of safety related empowerment: Internal Tools, Expectation of Support, and Trade-offs. Participants respond to each item using a five-point Likert scale (from "never true" to "always true") with the Trade-offs subscale being reversed scored. Scores on each subscale are summed to produce total scores. Higher scores indicate an increase in safety related empowerment.
Measured: up to 4 weeks post visit 1
Frequency of IPV-related episodes assessed using the Psychological Maltreatment of Women Inventory (PMWI)- Short form
The PMWI is a 14 item questionnaire that assesses psychological maltreatment. Response options on a 5-point Likert scale, ranging from never (1) to very often (5), for the last 6 months. Total score range from 14-70 with higher scores indicating more psychologically abusive experiences.
Measured: up to 1 year post visit 1, until child is 2 years of age
Frequency of IPV-related episodes assessed using the Conflict Tactic Scale 2 (CTS2) for partner's behaviors
The physical assault portion of the CTS2 is a 12 item questionnaire assessing chronicity and prevalence of IPV. Each item is scored on an 7-point Likert scale, ranging from 0 (never) to 6 (>20 times). Only items referring to the partner's behaviors will be included. Total scores range from 0-300 (for chronicity) and 0-12 (for prevalence) with higher scores denoting increased frequency of intimate partner violence.
Measured: up to 1 year post visit 1, until child is 2 years of age
Number of reports to Child Protective Services (CPS) for IPV
Number of reports called in to Child Protective Services (CPS) for IPV that identified child as a victim within one year of visit.
Measured: up to 1 year post visit 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start10 Jan 2024
- Primary completion15 Feb 2026
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intimate Partner 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An anticipated 100 caregivers and 100-150 children of these caregivers, and 85 professionals. Participants will be randomized (1:1) child-caregiver dyads who are reported to the New Haven, Milford and Hartford child protective services (CPS) offices after identified exposure to IPV to either the FCC model or usual child-focused care.
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Gunjan Tiyyagura, MD, MHS, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06071299
- Sponsor's protocol ID
- 2000035185
- Other IDs
- 1K23HD107178-01A1
- Status last verified
- May 2026
- First submitted
- 29 Sep 2023
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Family-Centered Care for Intimate Partner Violence (IPV)
- ClinicalTrials.gov ID
- NCT06071299
- Acronym / sponsor ID
- 2000035185
- Conditions
- Intimate Partner Violence
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 15 Feb 2026 (actual)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 6 Oct 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 purpose of the study will be to determine how participation in Family-Centered Care (FCC) compared to Child-centered care (CCC) will affect caregiver engagement in IPV-based community services, caregiver perceptions of empowerment and survivor-defined practice, and clinical outcomes for children exposed to IPV.
Detailed description
The study population includes victims of intimate partner violence whose children < 5-years old have been referred to Child Protective Services due to exposure to IPV and who have agreed to a medical evaluation for the child(ren) in the child advocacy center or the SCAN clinic and don't already have a connection to an IPV advocate. The study population will include adults who are primarily English or Spanish Language preferring. For professionals, the target audience will be local CPS investigators in the New Haven and Hartford CPS office, IPV advocates at the New Haven Umbrella Center for Intimate Partner Violence Services and The Hartford Interval House and child abuse pediatricians at Yale University School of Medicine and at the Connecticut Childrens Medical Center.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- An anticipated 100 caregivers and 100-150 children of these caregivers, and 85 professionals. Participants will be randomized (1:1) child-caregiver dyads who are reported to the New Haven, Milford and Hartford child protective services (CPS) offices after identified exposure to IPV to either the FCC model or usual child-focused care.
| Arm | Type | Receives |
|---|---|---|
| FCC model | Experimental | Behavioral: FCCParticipants will receive family-focused care. |
| CCC model | Active comparator | Behavioral: CCCParticipants will receive the usual child-focused care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Have a child < 5-years-old who been reported to Child Protectives Services for IPV exposure
- Parent > 18 years old who has agreed to a medical evaluation for the child at the child advocacy center
- Does not already have a connection to an IPV advocate
- Able to speak English or Spanish fluently
- Not a ward of department of children and families
Key exclusion criteria (2 listed)
- Ward of the state
- Language preference other than English or Spanish
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 |
|---|---|---|
| FCCChildren evaluated for abusive injuries. Caregiver offered meeting with IPV advocate during visit (survivor-centered care, immediate access to services; continued engagement with advocate for ongoing needs). Referral to Child-Study center for trauma follow up. Connection to pediatrician. Use of motivational interviewing to address IPV. | Behavioural | FCC model |
| CCCChildren evaluated for abusive injuries. Medical provider offers IPV resources to caregiver. Referral to Child-Study center for trauma follow up. Connection to pediatrician. Use of motivational interviewing to address IPV. | Behavioural | CCC model |
Primary outcome
Percentage of caregivers with follow-up visits with an IPV advocate
Time frame: up to 3 months post visit 1
Percentage of caregivers who have at least one follow-up visit with an IPV advocate by 3 months after the initial visit by self-report.
6 secondary outcomes
Percentage of evaluated children who complete a skeletal survey
Time frame: up to 4 weeks post visit 1
Perceptions of survivor-defined practice using the Survivor Defined Practice Scale (SDPS)
Time frame: up to 4 weeks post visit 1
Perceptions of safety-related empowerment using the Measure of Victim Empowerment Related to Safety (MOVERS) scale.
Time frame: up to 4 weeks post visit 1
Frequency of IPV-related episodes assessed using the Psychological Maltreatment of Women Inventory (PMWI)- Short form
Time frame: up to 1 year post visit 1, until child is 2 years of age
Frequency of IPV-related episodes assessed using the Conflict Tactic Scale 2 (CTS2) for partner's behaviors
Time frame: up to 1 year post visit 1, until child is 2 years of age
Number of reports to Child Protective Services (CPS) for IPV
Time frame: up to 1 year post visit 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: No
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SER Familia: A Family-Based Intervention Addressing Syndemic Conditions Among Latino Families
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RISE Versus Advocacy-based Enhanced Care as Usual for Patients Experiencing IPV
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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.
Gunjan Tiyyagura, MD, MHS principal investigator
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FCC and CCC in people with Intimate Partner Violence, run by Yale University at 2 sites 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 5 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Percentage of caregivers with follow-up visits with an IPV advocate (time frame: up to 3 months post visit 1). 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 27 May 2026.