Substance UseNCT05562557
A Regional Partnership to Improve Outcomes Through Fatherhood Engagement
A study testing Motivational Enhancement, HERO Dads Fatherhood Program and Contingency Management in people with Substance Use and Child Abuse, run by Montefiore Medical Center at 1 site in United States.
Trial summary
Montefiore will engage fathers in families at risk of substance misuse in the Bronx and neighboring communities. Families will be referred from Bronx and neighboring community-based child welfare systems, substance use disorder (SUD) treatment providers, and medical providers if identified at risk of substance use… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Substance Use, Child Abuse, Child Neglect
- What is being tested?
- Motivational Enhancement, HERO Dads Fatherhood Program and Contingency Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2023to Sep 2027
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- is a custodial or non-custodial father
- speaks English or Spanish
- has at least one child under the age of 18,
- someone in the family is identified as at-risk for substance use through: self-report of illicit substance use in the family, the presence of an SUD diagnosis in the family, a clinician/provider identified substance use risk, or the presence of a substance-related indicated child welfare allegation in the family
Who cannot join
- The placement of all children in the family in foster care
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10467
Alessandra de Marchena, LCSW, 718-401-5060, allongo@montefiore.org
Anita Jose, PhD, 7184015060, ajose@montefiore.org
About this study
Official title: A Regional Partnership for New York City to Improve Well-Being and Child Welfare Outcomes Among Families at Risk of Substance Misuse Through Fatherhood Engagement
Montefiore will engage fathers in families at risk of substance misuse in the Bronx and neighboring communities. Families will be referred from Bronx and neighboring community-based child welfare systems, substance use disorder (SUD) treatment providers, and medical providers if identified at risk of substance use concerns and will be randomly assigned to receive services as usual as part of the comparison group, or to receive enhanced services as part of the program group.
Enhanced services include: (1) Motivational Enhancement; (2) referral to Healthy, Empowered, Resilient, and Open (HERO) Dads fatherhood engagement program; (3) Contingency Management; and (4) Case Management.
- Conditions
- Substance Use, Child Abuse, Child Neglect, Fathers, Father-Child Relations
- Being tested
- Motivational Enhancement, HERO Dads Fatherhood Program, Contingency Management, Case Management
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational EnhancementBehavioural
Evidence-based adaptation of Motivational Interviewing (MI), designed to target ambivalence to change and create internal motivation to engage in substance abuse treatment
HERO Dads Fatherhood ProgramBehavioural
Use the 24/7 Dad fatherhood curriculum, delivered by Montefiore HERO Dads, with an additional 4-session employment education curriculum and 3-session parent coaching to reinforce individual skills learned in fatherhood curriculum. Curriculum designed to increase awareness, knowledge, and skills for parenting and co-parenting.
Contingency ManagementBehavioural
To improve attendance at services and abstinence outcomes.
Case ManagementBehavioural
Referrals to substance use disorder (SUD) treatment and engagement, mental health resources, public assistance resources, connection to the Office of Childhood Services and other case management needs.
| Study group | Role | What they receive |
|---|---|---|
| Services as Usual | No intervention | Randomly assigned to receive services as usual |
| Enhanced Fatherhood Services through Regional Partnership Grant Round 7 (RPG7) | Experimental | Randomly assigned to receive enhanced RPG7 services (motivational enhancement, fatherhood engagement services, contingency management, case management) Receives: Behavioral: Motivational Enhancement; Behavioral: HERO Dads Fatherhood Program; Behavioral: Contingency Management; Behavioral: Case Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child well-being
Child well-being will be assessed by the Child Behavior Checklist. This is a standardized self-report measure widely used in the measure of child behavior and child well-being. Separate forms are used for children aged 1.5-5, and 6-18. The questionnaire is completed by the caregiver using a series of Likert scales (0=absent, 1=sometimes, 2=often occurs). There are 113 questions, measuring a series of internalizing (e.g., anxious/ depressed, depressed, somatic complaints) and externalizing (e.g., attention problems, rule-breaking behavior, aggression) symptoms over the prior 6-months. Raw scores are standardized into t-scores, with elevated scores reflecting greater symptomatology when compared to a gender and aged normed population.
Measured: Baseline and 6 Month followup
Secondary outcomes (6)
Father engagement based on the Child-Parent Relationship Scale, Short form (CPRS-SF)
Father engagement will be measured by the Child-Parent Relationship Scale, Short form (CPRS-SF). The CPRS-SF is a 15-item self-report measure assessing the current relationship between parent and child. Items are rated on a 5-point Likert scale ranging from 1 ("definitely does not apply") to 5 ("definitively applies"). Ratings are averaged into groups of items corresponding to conflict items (8 items) and closeness (7 items) subscales for this study. Higher scores indicate higher levels of the specific construct (i.e., more conflict or more closeness). Higher conflict score reflects higher negativity; higher closeness score reflects warmth, affection, and open communication.
Measured: Baseline and 6 Month followup
Father engagement based on the Inventory of Father Involvement, Short form (IFI-SF)
Father engagement will also be measured by the Inventory of Father Involvement, Short Form (IFI-SF). The IFI-SF is a 26-item measure of father involvement, focusing on the following subscales: discipline and teaching responsibility, school encouragement, providing, time and talking together, praise and affection, developing talents, reading/homework, supporting the coparent, and attentiveness. Items are rated using a 7-point Likert scale ranging from 0 ("Very Poor") to 6 ("Excellent"). For this study, scores are averaged, yielding a score of 0-6 overall. Higher scores indicate higher levels of perceived father involvement.
Measured: Baseline and 6 Month followup
Father engagement based on the Parenting Alliance Inventory (PAI)
Father engagement will also be measured by the Parenting Alliance Inventory (PAI). The PAI is a 20-item scale that assesses the co-parenting relationship between parents. Items are rated using a 5-point Likert scale ranging from 1 ("Strongly Disagree") to 5 ("Strongly Agree"); for this study, scores are averaged for a range of 1-5. Higher scores indicate a stronger, more positive, and cooperative partnership.
Measured: Baseline and 6 Month followup
Father behavioral health based on the Addiction Severity Index (ASI, adapted)
Father behavioral health will be measured by the Addiction Severity Index (ASI, adapted). The ASI is a self-report measure addressing potential problems associated with substance use. This study will use only the drug and alcohol section. The drug and alcohol section of the ASI consists of a severity assessment where the participant is asked to rate the severity of their drug and alcohol addiction, over the past 30 days, using a numeric computation with many components. This measure summarizes the patient's need for treatment. Results for each component will be summarized by study arm.
Measured: Baseline and 6 Month followup
Father behavioral health based on the Center for Epidemiological Studies Depression Scale (CESD, adapted)
Father behavioral health will also be measured by the Center for Epidemiological Studies Depression Scale (CESD, adapted). This study uses a 12-item short form of this self-report scale is designed to measure depressive symptomatology in adult populations. Items are rated using a 4-point Likert scale ranging from 0 ("Rarely or none of the time (i.e., <1 day)") to 3 ("Most or all of the time (i.e., 5-7 days)"), yielding an overall possible score of 0-36 for this adaptation. Higher scores indicate more clinically significant depressive symptoms.
Measured: Baseline and 6 Month followup
Father behavioral health based on the Trauma Symptom Checklist-40 (TSC-40)
Father behavioral health will also be measured by the Trauma Symptom Checklist-40 (TSC-40). The TSC-40 evaluates symptomatology in adults associated with childhood or adult traumatic experiences. It measures aspects of posttraumatic stress and other symptom clusters found in some traumatized individuals. In this study, the parent will respond based on their own behavioral symptoms. The TSC-40 consists of 40 items across six domains (anxiety, depression, dissociation, sexual abuse trauma index, sexual problems, and sleep disturbance) wherein parents self-report trauma-related symptoms on a 4-point frequency scale ranging from 0 ("Never") to 3 ("Often"), yielding a total score of 0-120, such that higher scores are indicative of higher distress.
Measured: Baseline and 6 Month followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start9 May 2023
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance UseStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A 2:1 treatment:comparison randomization scheme is planned. Statistical Analysis System (SAS) will be used to generate the scheme and block randomization will be used to ensure the ratio. Randomization will not be stratified. The rationale for this is that it is believed participant characteristics would be similar across different enrollment resources (i.e., different enrollment sites). The evaluator and statistician, who do not have access to the participants or their records, will be generate the randomization scheme.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Albert Einstein College of Medicine, Mathematica Policy Research, Inc., New York State Office of Children and Family Services, New York State Office of Addiction Services and Supports, New York City Human Resources Administration (HRA), Children's Bureau - Administration for Children and Families, New York City Administration for Children's Services
- Responsible party
- Sponsor
- Investigators
- Scott Wetzler, PhD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562557
- Sponsor's protocol ID
- 2022-14401
- Other IDs
- 90-CU-0116
- Status last verified
- Mar 2026
- First submitted
- 26 Sep 2022
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No current plan. May be possible to provide individual data (de-identified) for secondary data analysis.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Regional Partnership for New York City to Improve Well-Being and Child Welfare Outcomes Among Families at Risk of Substance Misuse Through Fatherhood Engagement
- ClinicalTrials.gov ID
- NCT05562557
- Acronym / sponsor ID
- 2022-14401
- Conditions
- Substance Use, Child Abuse, Child Neglect, Fathers, Father-Child Relations
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- Albert Einstein College of Medicine, Mathematica Policy Research, Inc., New York State Office of Children and Family Services, New York State Office of Addiction Services and Supports, New York City Human Resources Administration (HRA), Children's Bureau - Administration for Children and Families, New York City Administration for Children's Services
- Study start
- 9 May 2023 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 30 Sep 2022 (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.
Montefiore will engage fathers in families at risk of substance misuse in the Bronx and neighboring communities. Families will be referred from Bronx and neighboring community-based child welfare systems, substance use disorder (SUD) treatment providers, and medical providers if identified at risk of substance use concerns and will be randomly assigned to receive services as usual as part of the comparison group, or to receive enhanced services as part of the program group.
Enhanced services include: (1) Motivational Enhancement; (2) referral to Healthy, Empowered, Resilient, and Open (HERO) Dads fatherhood engagement program; (3) Contingency Management; and (4) Case Management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A 2:1 treatment:comparison randomization scheme is planned. Statistical Analysis System (SAS) will be used to generate the scheme and block randomization will be used to ensure the ratio. Randomization will not be stratified. The rationale for this is that it is believed participant characteristics would be similar across different enrollment resources (i.e., different enrollment sites). The evaluator and statistician, who do not have access to the participants or their records, will be generate the randomization scheme.
| Arm | Type | Receives |
|---|---|---|
| Services as Usual | No intervention | –Randomly assigned to receive services as usual |
| Enhanced Fatherhood Services through Regional Partnership Grant Round 7 (RPG7) | Experimental | Behavioral: Motivational Enhancement, Behavioral: HERO Dads Fatherhood Program, Behavioral: Contingency Management, Behavioral: Case ManagementRandomly assigned to receive enhanced RPG7 services (motivational enhancement, fatherhood engagement services, contingency management, case management) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- is a custodial or non-custodial father
- speaks English or Spanish
- has at least one child under the age of 18,
- someone in the family is identified as at-risk for substance use through: self-report of illicit substance use in the family, the presence of an SUD diagnosis in the family, a clinician/provider identified substance use risk, or the presence of a substance-related indicated child welfare allegation in the family
Key exclusion criteria (1 listed)
- The placement of all children in the family in foster care
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 |
|---|---|---|
| Motivational EnhancementEvidence-based adaptation of Motivational Interviewing (MI), designed to target ambivalence to change and create internal motivation to engage in substance abuse treatment | Behavioural | Enhanced Fatherhood Services through Regional Partnership Grant Round 7 (RPG7) |
| HERO Dads Fatherhood ProgramUse the 24/7 Dad fatherhood curriculum, delivered by Montefiore HERO Dads, with an additional 4-session employment education curriculum and 3-session parent coaching to reinforce individual skills learned in fatherhood curriculum. Curriculum designed to increase awareness, knowledge, and skills for parenting and co-parenting. | Behavioural | Enhanced Fatherhood Services through Regional Partnership Grant Round 7 (RPG7) |
| Contingency ManagementTo improve attendance at services and abstinence outcomes. | Behavioural | Enhanced Fatherhood Services through Regional Partnership Grant Round 7 (RPG7) |
| Case ManagementReferrals to substance use disorder (SUD) treatment and engagement, mental health resources, public assistance resources, connection to the Office of Childhood Services and other case management needs. | Behavioural | Enhanced Fatherhood Services through Regional Partnership Grant Round 7 (RPG7) |
Primary outcome
Child well-being
Time frame: Baseline and 6 Month followup
Child well-being will be assessed by the Child Behavior Checklist. This is a standardized self-report measure widely used in the measure of child behavior and child well-being. Separate forms are used for children aged 1.5-5, and 6-18. The questionnaire is completed by the caregiver using a series of Likert scales (0=absent, 1=sometimes, 2=often occurs). There are 113 questions, measuring a series of internalizing (e.g., anxious/ depressed, depressed, somatic complaints) and externalizing (e.g., attention problems, rule-breaking behavior, aggression) symptoms over the prior 6-months. Raw scores are standardized into t-scores, with elevated scores reflecting greater symptomatology when compared to a gender and aged normed population.
6 secondary outcomes
Father engagement based on the Child-Parent Relationship Scale, Short form (CPRS-SF)
Time frame: Baseline and 6 Month followup
Father engagement based on the Inventory of Father Involvement, Short form (IFI-SF)
Time frame: Baseline and 6 Month followup
Father engagement based on the Parenting Alliance Inventory (PAI)
Time frame: Baseline and 6 Month followup
Father behavioral health based on the Addiction Severity Index (ASI, adapted)
Time frame: Baseline and 6 Month followup
Father behavioral health based on the Center for Epidemiological Studies Depression Scale (CESD, adapted)
Time frame: Baseline and 6 Month followup
Father behavioral health based on the Trauma Symptom Checklist-40 (TSC-40)
Time frame: Baseline and 6 Month followup
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 24 Mar 2026.
- Individual participant dataSharing planned: Undecided. No current plan. May be possible to provide individual data (de-identified) for secondary data analysis.
Related trials for Substance Use
RecruitingObservational study
Structural Stressors, Reward Related Decision Making and Substance Use Risk
Substance Use Risk, Structural Stressors
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Scott Wetzler, PhD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Enhancement, HERO Dads Fatherhood Program and Contingency Management in people with Substance Use and Child Abuse, run by Montefiore Medical Center 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 4 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: looking for participants now, as of the sponsor's last update on 24 Mar 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?
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 Anita Jose, PhD (718-401-5060, ajose@montefiore.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child well-being (time frame: Baseline and 6 Month followup). 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 24 Mar 2026.