Domestic ViolenceNCT03883932
Fatherhood Focused Family Violence Education Program
A study testing Fatherhood Focused FVEP (F3) and Family Violence Education Program (FVEP) in people with Domestic Violence, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to explore the feasibility of a novel intervention approach for fathers arrested for an initial episode of intimate partner violence (IPV) by systematically developing an alternate version of a standard, statewide, court-mandated Family Violence Education Program (FVEP) to focus… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Domestic Violence
- What is being tested?
- Fatherhood Focused FVEP (F3) and Family Violence Education Program (FVEP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 11 Feb 2021
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fathers referred to the FVEP program as a pretrial diversion following their first arrest for an incident of IPV with a female partner.
- Fathers must have at least one biological child under the age of 18.
- Fathers must have at least monthly contact with one of their biological children.
Who cannot join
- Fathers will be excluded if they are arrested for violence perpetrated against someone other than a current or former female partner.
- Fathers will be excluded if there is evidence of psychotic of suicidal symptoms on the Brief Symptom Inventory.
- Fathers will be excluded if they unable to complete questionnaires and group intervention in English.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University Child Study Center
New Haven, Connecticut, 06520
About this study
The purpose of this study is to explore the feasibility of a novel intervention approach for fathers arrested for an initial episode of intimate partner violence (IPV) by systematically developing an alternate version of a standard, statewide, court-mandated Family Violence Education Program (FVEP) to focus specifically on the importance of fathering within a cognitive-behavioral intervention to be called Fatherhood Focused FVEP (F3).
Read the detailed description
This study will aim to modify the treatment as usual FVEP framework to be father focused. Materials will be developed to accommodate the change in scope of program focus for the purposes of training and supervising group leaders. An evaluation of the fidelity to the original FVEP model will be assessed through the review of service delivery.
In addition, the acceptability of Fatherhood Focused FVEP (F3) will be compared to the treatment as usual, FVEP as it is presently implemented. To do this, fathers who participate in FVEP will be compared to men who participate in F3 around the constructs: group cohesion, motivation to change, satisfaction with the program and rates of successful completion. Tertiary outcomes will include the assessment of: aggression toward intimate partners and hostile-aggressive parenting behaviors as reported on assessment measures and subsequent arrest records.
- Conditions
- Domestic Violence
- Being tested
- Fatherhood Focused FVEP (F3), Family Violence Education Program (FVEP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fatherhood Focused FVEP (F3)Behavioural
F3 is designed to focus specifically on the importance of fathering within a cognitive-behavioral intervention.
Family Violence Education Program (FVEP)Behavioural
FVEP is a court-mandated program intended to treat those arrested for intimate partner violence (IPV).
| Study group | Role | What they receive |
|---|---|---|
| F3 Program | Experimental | The F3 group will focus on the fatherhood role each session. The topic of children and parenting will be applied to each of the standard FVEP topics. Receives: Behavioral: Fatherhood Focused FVEP (F3) |
| FVEP Program | Active comparator | A retrospective control group who received the standard FVEP will be included in this arm. Receives: Behavioral: Family Violence Education Program (FVEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recidivism Incidence
Recidivism will be determined through the review of state arrest records for additional IPV arrests.
Measured: 12 Months
Secondary outcomes (7)
Group Cohesion
Group cohesion will be assessed using Group Attitude Scale. Group Attitude scale is a self report instrument that consists of 20 items. The range of scores is from 20 to 180, where a higher score indicates WORSE cohesion.
Measured: 3, 6 and 9 weeks
Motivation to Change
Motivation to Change will be assessed using University of Rhode Island Change Assessment (URICA). URICIA is a self report instrument that consists of 32 items. The range of scores is from 32 to 160, where a higher score indicates GREATER motivation to change.
Measured: 3, 6 and 9 weeks
Intimate Partner Violence (IPV)
IPV perpetration will be assessed using the Abusive Behavior Inventory (ABI). The ABI is a 30 item inventory that uses a 5 point Likert scale for each response. The greater the score, the greater the severity.
Measured: Baseline and 9 Weeks
Substance Abuse
Substance abuse will be assessed using the Short-Michigan Alcohol Screening Test and the Drug Abuse Screening Test-10. This 10 item inventory characterizes behavior associated with alcoholism, the higher the score, the greater the severity of alcoholism in a respondent.
Measured: Baseline and 9 Weeks
Parenting Behaviors
Parenting behaviors will be assessed with Parental Acceptance Rejection Questionnaire which includes 24 items on a 4 point likert scale. Higher scores mean greater negative parenting behaviors.
Measured: Baseline and 9 Weeks
Co-Parenting Behaviors
Co-parenting behaviors will be assessed using the Coparenting Relationship Scale.
Measured: Baseline and 9 Weeks
Perspective Taking
The Perspective Taking Questionnaire is a 7 item questionnaire measured on a 5 point likert scale. Higher scores mean better perspective taking
Measured: Baseline and 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start1 Sep 2018
- Primary completion30 Sep 2019
- Study completion11 Feb 2021
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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883932
- Sponsor's protocol ID
- 2000022823
- Status last verified
- Apr 2021
- First submitted
- 18 Mar 2019
- Last updated
- 22 Apr 2021
- 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 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatherhood Focused Family Violence Education Program
- ClinicalTrials.gov ID
- NCT03883932
- Acronym / sponsor ID
- 2000022823
- Conditions
- Domestic Violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 11 Feb 2021 (actual)
- First posted
- 21 Mar 2019 (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 this study is to explore the feasibility of a novel intervention approach for fathers arrested for an initial episode of intimate partner violence (IPV) by systematically developing an alternate version of a standard, statewide, court-mandated Family Violence Education Program (FVEP) to focus specifically on the importance of fathering within a cognitive-behavioral intervention to be called Fatherhood Focused FVEP (F3).
Detailed description
This study will aim to modify the treatment as usual FVEP framework to be father focused. Materials will be developed to accommodate the change in scope of program focus for the purposes of training and supervising group leaders. An evaluation of the fidelity to the original FVEP model will be assessed through the review of service delivery.
In addition, the acceptability of Fatherhood Focused FVEP (F3) will be compared to the treatment as usual, FVEP as it is presently implemented. To do this, fathers who participate in FVEP will be compared to men who participate in F3 around the constructs: group cohesion, motivation to change, satisfaction with the program and rates of successful completion. Tertiary outcomes will include the assessment of: aggression toward intimate partners and hostile-aggressive parenting behaviors as reported on assessment measures and subsequent arrest records.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| F3 Program | Experimental | Behavioral: Fatherhood Focused FVEP (F3)The F3 group will focus on the fatherhood role each session. The topic of children and parenting will be applied to each of the standard FVEP topics. |
| FVEP Program | Active comparator | Behavioral: Family Violence Education Program (FVEP)A retrospective control group who received the standard FVEP will be included in this arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Fathers referred to the FVEP program as a pretrial diversion following their first arrest for an incident of IPV with a female partner.
- Fathers must have at least one biological child under the age of 18.
- Fathers must have at least monthly contact with one of their biological children.
Key exclusion criteria (3 listed)
- Fathers will be excluded if they are arrested for violence perpetrated against someone other than a current or former female partner.
- Fathers will be excluded if there is evidence of psychotic of suicidal symptoms on the Brief Symptom Inventory.
- Fathers will be excluded if they unable to complete questionnaires and group intervention in English.
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 |
|---|---|---|
| Fatherhood Focused FVEP (F3)F3 is designed to focus specifically on the importance of fathering within a cognitive-behavioral intervention. | Behavioural | F3 Program |
| Family Violence Education Program (FVEP)FVEP is a court-mandated program intended to treat those arrested for intimate partner violence (IPV). | Behavioural | FVEP Program |
Primary outcome
Recidivism Incidence
Time frame: 12 Months
Recidivism will be determined through the review of state arrest records for additional IPV arrests.
7 secondary outcomes
Group Cohesion
Time frame: 3, 6 and 9 weeks
Motivation to Change
Time frame: 3, 6 and 9 weeks
Intimate Partner Violence (IPV)
Time frame: Baseline and 9 Weeks
Substance Abuse
Time frame: Baseline and 9 Weeks
Parenting Behaviors
Time frame: Baseline and 9 Weeks
Co-Parenting Behaviors
Time frame: Baseline and 9 Weeks
Perspective Taking
Time frame: Baseline and 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fatherhood Focused FVEP (F3) and Family Violence Education Program (FVEP) 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 22 Apr 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Recidivism Incidence (time frame: 12 Months). 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 22 Apr 2021.