Substance MisusePhase 2NCT06650267
Substance Misuse and Family Violence Treatment Fathers
A Phase 2 study testing Fathers for Change (F4C) and Individual Drug Counseling (IDC) in people with Substance Misuse and Violence, Domestic, run by Yale University at 2 sites in United States.
Trial summary
This study involves a randomized controlled trial of Fathers for Change (F4C) compared to Individual Drug Counseling (IDC) with a sample of 280 fathers enrolled in substance use (SU) treatment within community or veterans (VA) healthcare settings to (a) demonstrate F4C efficacy compared to IDC in reducing SU and… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Substance Misuse, Violence, Domestic, Child Abuse
- What is being tested?
- Fathers for Change (F4C) and Individual Drug Counseling (IDC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Feb 2025to 31 Dec 2030
- Phase
- Phase 2
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- meet DSM-5 criteria for an SU disorder at the time of assessment at APT or VACHS;
- report FV within the last 18 months prior to screening (based on self, court, police or child protection reports);
- have at least one biological child aged 1 to 12 years with whom they live or have at least twice per month in person visits;
- are able to complete assessments in English; and
- agree to have their female coparents (mother of the youngest child) contacted for participation of their youngest child. If a participant has more than one child in the age range, the youngest will be the target of assessment and treatment.
Who cannot join
- an active full/no contact protective order pertaining to their child;
- physiological addiction to a substance that requires detoxification (such individuals may be re-evaluated following detox);
- cognitive impairment (a mini mental state score <25);
- current untreated psychotic/bipolar disorder;
- currently suicidal or homicidal based on Brief Symptom Inventory Screening and follow-up on positive responses; or
- are currently receiving weekly individual therapy for Substance misuse or family violence
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Yale University Child Study Center
New Haven, Connecticut, 06520
Quyen Do, PhD, 2037847707, quyen.do@yale.edu
- Recruiting
APT Foundation
West Haven, Connecticut, 06516
Diana Potwardowski
About this study
Official title: Substance Misuse and Family Violence Treatment for Fathers
This study involves a randomized controlled trial of Fathers for Change (F4C) compared to Individual Drug Counseling (IDC) with a sample of 280 fathers enrolled in substance use (SU) treatment within community or veterans (VA) healthcare settings to (a) demonstrate F4C efficacy compared to IDC in reducing SU and family violence (FV) at end of treatment, 3- and 6-month post-treatment follow-up, and (b) document improved emotion regulation as the mechanism within F4C that results in reduced SU and FV.
- Conditions
- Substance Misuse, Violence, Domestic, Child Abuse
- Being tested
- Fathers for Change (F4C), Individual Drug Counseling (IDC)
- Keywords
- substance misuse, intimate partner violence, domestic violence, treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fathers for Change (F4C)Behavioural
Defining features of F4C delivered over 18 sessions: 1) focus on the fathers model of fatherhood as a motivator for change, 2) focus on understanding and identifying feelings, teaching skills to identify and change emotional dysregulation that lead to both SU and FV, 3) co-parent communication skills to reduce stress and improve problem solving, 4) restorative parenting (see Table 1 and figure 1)127. F4C focuses on reflective understanding of emotional experiences, how that impacts thoughts and behaviors related to SU, FV, co-parenting/parenting each session. Through greater self-awareness, the father is better able to apply coping, communication and parenting skills introduced to reduce SU and FV.
Individual Drug Counseling (IDC)Behavioural
IDC is an individual evidence-based SU treatment84 that incorporates two elements: endorsement of the disease model and the spiritual dimensions of recovery. These elements differentiate the approach from F4C. IDC is influenced by 12-step recovery philosophy and participation in 12-step groups like NA are encouraged. The model places focus on the individual in recovery without a focus on fatherhood or co-parenting. IDC will be offered in an 18-session format.
| Study group | Role | What they receive |
|---|---|---|
| Fathers for Change | Experimental | Not described Receives: Behavioral: Fathers for Change (F4C) |
| Individual Drug Counseling | Active comparator | Not described Receives: Behavioral: Individual Drug Counseling (IDC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Substance Misuse
Self-reported days of substance misuse reported a positive breathalyzer/urine tox screen will be used to create a sum of the number of weeks with use during treatment and at each follow-up period.
Measured: Baseline (week 0), weekly during treatment for through 18 week, Post-Treatment at week 19, week 32 and week 45
Family Violence (FV)
Any instance of FV either toward a partner or child identified by any report (self-report on the Timeline Followback weekly surveys, child protection or arrest record) will be counted to allow for the best estimate of FV across reports resulting in a sum count of the number of FV incidents during the 18 weeks of treatment and from post-treatment to each follow-up timepoint
Measured: Baseline (week 0), weekly during treatment for through 18 week, Post-Treatment at week 19, week 32 and week 45
Secondary outcomes (2)
Emotion Dysregulation
The Difficulties in Emotion Regulation Scale will be used to measure self-reported emotion regulation. Sum scores range from 18 to 90 with higher scores suggesting more impaired emotion regulation.
Measured: Baseline (week 0), Post-Treatment at week 19, week 32 and week 45
Articulated Thoughts in Simulated Situations (ATSS)
The participants responses to the ATSS will be coded for hostile responding and will serve as a non-self-report measure of emotion regulation. Scores range from 0 to 5 with 5 being greater hostile responding across scenarios.
Measured: Baseline (week 0) and Post-Treatment (week 18)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start17 Feb 2025
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance MisuseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- APT Foundation, Inc., VA Connecticut Healthcare System, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Carla S Stover, Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06650267
- Sponsor's protocol ID
- 2000038147
- Other IDs
- 1R01DA059914-01A1
- Status last verified
- May 2026
- First submitted
- 16 Oct 2024
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Clinical/assessment data will be deposited into Harvard Dataverse at the conclusion of study data collection and publication of primary study specific aims.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substance Misuse and Family Violence Treatment for Fathers
- ClinicalTrials.gov ID
- NCT06650267
- Acronym / sponsor ID
- 2000038147
- Conditions
- Substance Misuse, Violence, Domestic, Child Abuse
- Keywords
- substance misuse, intimate partner violence, domestic violence, treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- APT Foundation, Inc., VA Connecticut Healthcare System, National Institute on Drug Abuse (NIDA)
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 21 Oct 2024 (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.
This study involves a randomized controlled trial of Fathers for Change (F4C) compared to Individual Drug Counseling (IDC) with a sample of 280 fathers enrolled in substance use (SU) treatment within community or veterans (VA) healthcare settings to (a) demonstrate F4C efficacy compared to IDC in reducing SU and family violence (FV) at end of treatment, 3- and 6-month post-treatment follow-up, and (b) document improved emotion regulation as the mechanism within F4C that results in reduced SU and FV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fathers for Change | Experimental | Behavioral: Fathers for Change (F4C) |
| Individual Drug Counseling | Active comparator | Behavioral: Individual Drug Counseling (IDC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- meet DSM-5 criteria for an SU disorder at the time of assessment at APT or VACHS;
- report FV within the last 18 months prior to screening (based on self, court, police or child protection reports);
- have at least one biological child aged 1 to 12 years with whom they live or have at least twice per month in person visits;
- are able to complete assessments in English; and
- agree to have their female coparents (mother of the youngest child) contacted for participation of their youngest child. If a participant has more than one child in the age range, the youngest will be the target of assessment and treatment.
Key exclusion criteria (6 listed)
- an active full/no contact protective order pertaining to their child;
- physiological addiction to a substance that requires detoxification (such individuals may be re-evaluated following detox);
- cognitive impairment (a mini mental state score <25);
- current untreated psychotic/bipolar disorder;
- currently suicidal or homicidal based on Brief Symptom Inventory Screening and follow-up on positive responses; or
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 |
|---|---|---|
| Fathers for Change (F4C)Defining features of F4C delivered over 18 sessions: 1) focus on the fathers model of fatherhood as a motivator for change, 2) focus on understanding and identifying feelings, teaching skills to identify and change emotional dysregulation that lead to both SU and FV, 3) co-parent communication skills to reduce stress and improve problem solving, 4) restorative parenting (see Table 1 and figure 1)127. F4C focuses on reflective understanding of emotional experiences, how that impacts thoughts and behaviors related to SU, FV, co-parenting/parenting each session. Through greater self-awareness, the father is better able to apply coping, communication and parenting skills introduced to reduce SU and FV. | Behavioural | Fathers for Change |
| Individual Drug Counseling (IDC)IDC is an individual evidence-based SU treatment84 that incorporates two elements: endorsement of the disease model and the spiritual dimensions of recovery. These elements differentiate the approach from F4C. IDC is influenced by 12-step recovery philosophy and participation in 12-step groups like NA are encouraged. The model places focus on the individual in recovery without a focus on fatherhood or co-parenting. IDC will be offered in an 18-session format. | Behavioural | Individual Drug Counseling |
Primary outcome
Substance Misuse
Time frame: Baseline (week 0), weekly during treatment for through 18 week, Post-Treatment at week 19, week 32 and week 45
Self-reported days of substance misuse reported a positive breathalyzer/urine tox screen will be used to create a sum of the number of weeks with use during treatment and at each follow-up period.
Family Violence (FV)
Time frame: Baseline (week 0), weekly during treatment for through 18 week, Post-Treatment at week 19, week 32 and week 45
Any instance of FV either toward a partner or child identified by any report (self-report on the Timeline Followback weekly surveys, child protection or arrest record) will be counted to allow for the best estimate of FV across reports resulting in a sum count of the number of FV incidents during the 18 weeks of treatment and from post-treatment to each follow-up timepoint
2 secondary outcomes
Emotion Dysregulation
Time frame: Baseline (week 0), Post-Treatment at week 19, week 32 and week 45
Articulated Thoughts in Simulated Situations (ATSS)
Time frame: Baseline (week 0) and Post-Treatment (week 18)
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 22 May 2026.
- Individual participant dataSharing planned: Yes. Clinical/assessment data will be deposited into Harvard Dataverse at the conclusion of study data collection and publication of primary study specific aims.
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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.
Carla S Stover, Ph.D. 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 Phase 2 study testing Fathers for Change (F4C) and Individual Drug Counseling (IDC) in people with Substance Misuse and Violence, Domestic, 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 6 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: looking for participants now, as of the sponsor's last update on 22 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Carla S Stover, Ph.D. (2037853486, carla.stover@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Substance Misuse (time frame: Baseline (week 0), weekly during treatment for through 18 week, Post-Treatment at week 19, week 32 and week 45). The study lists 2 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 22 May 2026.