Domestic ViolencePhase 1/2NCT01385553
Fathers for Change for Men With Co-occurring Domestic Violence and Substance Abuse
A Phase 1/2 study testing Fathers for Change and Individual Drug Counseling in people with Domestic Violence and Substance Abuse, run by Yale University at 1 site in United States.
Trial summary
Social service systems rarely acknowledge the status of men as fathers in the conceptualization and delivery of treatment for substance abuse or domestic violence. Although there has been extensive focus on the treatment of mothers who abuse substances, are victims of intimate partner violence (IPV) (defined as… Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Domestic Violence, Substance Abuse, Parenting
- What is being tested?
- Fathers for Change and Individual Drug Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Jun 2013
- Phase
- Phase 1/2
- 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 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- meet current DSM-IV criteria for substance abuse and who have used a substance within the 60 days prior to screening;
- have a police reported incident of IPV (pushing, slapping, kicking) within 6 months of referral;
- have at least one biological child under the age of 7 with whom they reside or have at least weekly visitation.
Who cannot join
- Have histories of severe physical violence (e.g. choking, causing hospitalization);
- Men who have an active NO CONTACT protective order pertaining to their partner or child;
- Men whose female partners indicate that they do not want the child to participate;
- If the female partner indicates that she believes her child is afraid of his/her father and will NOT want to participate;
- Men who are currently in withdrawal from substances and in need of detoxification;
- Have cognitive impairment or a lifetime history of any psychotic or bipolar disorder; or
- Are currently suicidal or homicidal.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial of Fathers for Change: An Intervention for Fathers With Co-Occuring Domestic Violence and Substance Abuse
Social service systems rarely acknowledge the status of men as fathers in the conceptualization and delivery of treatment for substance abuse or domestic violence. Although there has been extensive focus on the treatment of mothers who abuse substances, are victims of intimate partner violence (IPV) (defined as physical aggression and/or psychological abuse and control at the hands of an intimate partner), or maltreat their children there has been little consideration of the need for interventions for fathers with histories of co-morbid IPV and substance abuse. It is estimated that between 10 and 17.8 million children are witness to violence in their homes each year. National and regional samples indicate 50-70% of families impacted by IPV and the typically co-occurring substance abuse have children under the age of seven. Large percentages of these men continue to live with or have consistent contact with their young children despite aggression and substance use.
Court mandated treatments for perpetrators of domestic violence have become the norm, however the efficacy of these treatments is questionable and most do not speak to the broader needs of batterers and their families. How batterer's treatments might impact parenting and father-child relationships and the psychosocial functioning of children is vastly understudied and not currently understood. Since batterer treatments are court mandated and require tremendous financial and community resources, the efficacy of these interventions in stopping the cycle of domestic violence and improving the health and well-being of the batterer, his partner and children is crucial. There are currently NO evidence-based treatments that address co-morbid substance abuse and domestic violence perpetration with emphasis on paternal parenting and the father-child relationship. Consequently, the proposed psychotherapy development project will develop and evaluate the potential efficacy of a novel, relational parent intervention for fathers with co-morbid substance abuse and IPV who have young children. The goals of this intervention are to decrease aggression and substance abuse by increasing focus on fathering and an improved father-child relationship.
- Conditions
- Domestic Violence, Substance Abuse, Parenting
- Being tested
- Fathers for Change, Individual Drug Counseling
- 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.
Fathers for ChangeBehavioural
Also called Integrated Father Treatment for Domestic Violence
FATHERS FOR CHANGE comprises 16, 60 minute sessions of treatment utilizing components of three evidence based practices: SADV-Cognitive Behavioral Therapy, Behavioral Couple Therapy and Child-Parent Psychotherapy. The goals of the intervention are: 1) decreased substance abuse and IPV by teaching coping and anger management skills, 2) improved communication and increased problem solving around shared parenting 3) parenting education including child development and the impact of violence on children, 4) discussion of discipline practices and development of behavior modification or positive reinforcement plans, and 5) attachment focused parent-child play sessions to coach fathers in play with their children and process traumatic experiences.
Individual Drug CounselingBehavioural
Also called IDC
Individual drug counseling focuses on the symptoms of drug addiction and related areas of impaired functioning and the content and structure of the patient's ongoing recovery program. This model of counseling is time limited and emphasizes behavioral change. It gives the patient coping strategies and tools for recovery and promotes 12-step ideology and participation. The primary goal of addiction counseling is to assist the addict in achieving and maintaining abstinence from addictive chemicals and behaviors. The secondary goal is to help the addict recover from the damage the addiction has caused in his or her life.
| Study group | Role | What they receive |
|---|---|---|
| Individual Drug Counseling | Active comparator | Not described Receives: Behavioral: Individual Drug Counseling |
| Fathers for Change | Experimental | Not described Receives: Behavioral: Fathers for Change |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in Verbal and Physical Aggression
Conflict Tactics Scale and the TimeLine Follow-back calendar interview
Measured: Baseline (Start of Tx), 4 month follow-up, 7 month follow-up
Decrease in Substance Abuse
urinalysis results and self report
Measured: weekly for months 1-4, 7 month followup
Decrease in Negative Parenting Behavior
IOWA, Adult child relationship questionnaire, Parental Acceptance Rejection Questionnaire
Measured: baseline, 4 month, 7 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Carla Stover, Yale University
- Investigators
- Carla S Stover, Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01385553
- Sponsor's protocol ID
- 1003006541
- Other IDs
- 1K23DA023334-01A2
- Status last verified
- Feb 2014
- First submitted
- 14 Jun 2011
- Last updated
- 19 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Easton CJ, Mandel DL, Hunkele KA, Nich C, Rounsaville BJ, Carroll KM. A cognitive behavioral therapy for alcohol-dependent domestic violence offenders: an integrated substance abuse-domestic violence treatment approach (SADV). Am J Addict. 2007 Jan-Feb;16(1):24-31. doi: 10.1080/10550490601077809.
PubMed 17364418
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Fathers for Change: An Intervention for Fathers With Co-Occuring Domestic Violence and Substance Abuse
- ClinicalTrials.gov ID
- NCT01385553
- Acronym / sponsor ID
- 1003006541
- Conditions
- Domestic Violence, Substance Abuse, Parenting
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jun 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 30 Jun 2011 (estimated)
- 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.
Social service systems rarely acknowledge the status of men as fathers in the conceptualization and delivery of treatment for substance abuse or domestic violence. Although there has been extensive focus on the treatment of mothers who abuse substances, are victims of intimate partner violence (IPV) (defined as physical aggression and/or psychological abuse and control at the hands of an intimate partner), or maltreat their children there has been little consideration of the need for interventions for fathers with histories of co-morbid IPV and substance abuse. It is estimated that between 10 and 17.8 million children are witness to violence in their homes each year. National and regional samples indicate 50-70% of families impacted by IPV and the typically co-occurring substance abuse have children under the age of seven. Large percentages of these men continue to live with or have consistent contact with their young children despite aggression and substance use.
Court mandated treatments for perpetrators of domestic violence have become the norm, however the efficacy of these treatments is questionable and most do not speak to the broader needs of batterers and their families. How batterer's treatments might impact parenting and father-child relationships and the psychosocial functioning of children is vastly understudied and not currently understood. Since batterer treatments are court mandated and require tremendous financial and community resources, the efficacy of these interventions in stopping the cycle of domestic violence and improving the health and well-being of the batterer, his partner and children is crucial. There are currently NO evidence-based treatments that address co-morbid substance abuse and domestic violence perpetration with emphasis on paternal parenting and the father-child relationship. Consequently, the proposed psychotherapy development project will develop and evaluate the potential efficacy of a novel, relational parent intervention for fathers with co-morbid substance abuse and IPV who have young children. The goals of this intervention are to decrease aggression and substance abuse by increasing focus on fathering and an improved father-child relationship.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individual Drug Counseling | Active comparator | Behavioral: Individual Drug Counseling |
| Fathers for Change | Experimental | Behavioral: Fathers for Change |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- meet current DSM-IV criteria for substance abuse and who have used a substance within the 60 days prior to screening;
- have a police reported incident of IPV (pushing, slapping, kicking) within 6 months of referral;
- have at least one biological child under the age of 7 with whom they reside or have at least weekly visitation.
Key exclusion criteria (7 listed)
- Have histories of severe physical violence (e.g. choking, causing hospitalization);
- Men who have an active NO CONTACT protective order pertaining to their partner or child;
- Men whose female partners indicate that they do not want the child to participate;
- If the female partner indicates that she believes her child is afraid of his/her father and will NOT want to participate;
- Men who are currently in withdrawal from substances and in need of detoxification;
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 ChangeAlso: Integrated Father Treatment for Domestic ViolenceFATHERS FOR CHANGE comprises 16, 60 minute sessions of treatment utilizing components of three evidence based practices: SADV-Cognitive Behavioral Therapy, Behavioral Couple Therapy and Child-Parent Psychotherapy. The goals of the intervention are: 1) decreased substance abuse and IPV by teaching coping and anger management skills, 2) improved communication and increased problem solving around shared parenting 3) parenting education including child development and the impact of violence on children, 4) discussion of discipline practices and development of behavior modification or positive reinforcement plans, and 5) attachment focused parent-child play sessions to coach fathers in play with their children and process traumatic experiences. | Behavioural | Fathers for Change |
| Individual Drug CounselingAlso: IDCIndividual drug counseling focuses on the symptoms of drug addiction and related areas of impaired functioning and the content and structure of the patient's ongoing recovery program. This model of counseling is time limited and emphasizes behavioral change. It gives the patient coping strategies and tools for recovery and promotes 12-step ideology and participation. The primary goal of addiction counseling is to assist the addict in achieving and maintaining abstinence from addictive chemicals and behaviors. The secondary goal is to help the addict recover from the damage the addiction has caused in his or her life. | Behavioural | Individual Drug Counseling |
Primary outcome
Decrease in Verbal and Physical Aggression
Time frame: Baseline (Start of Tx), 4 month follow-up, 7 month follow-up
Conflict Tactics Scale and the TimeLine Follow-back calendar interview
Decrease in Substance Abuse
Time frame: weekly for months 1-4, 7 month followup
urinalysis results and self report
Decrease in Negative Parenting Behavior
Time frame: baseline, 4 month, 7 month follow-up
IOWA, Adult child relationship questionnaire, Parental Acceptance Rejection Questionnaire
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 19 Feb 2014.
- Background: PubMed 17364418Easton CJ, Mandel DL, Hunkele KA, Nich C, Rounsaville BJ, Carroll KM. A cognitive behavioral therapy for alcohol-dependent domestic violence offenders: an integrated substance abuse-domestic violence treatment approach (SADV). Am J Addict. 2007 Jan-Feb;16(1):24-31. doi: 10.1080/10550490601077809.
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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.
Carla S Stover, Ph.D. principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Fathers for Change and Individual Drug Counseling in people with Domestic Violence and Substance Abuse, 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 7 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 19 Feb 2014. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
Decrease in Verbal and Physical Aggression (time frame: Baseline (Start of Tx), 4 month follow-up, 7 month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01385553, which also lists 1 linked publication.
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 19 Feb 2014.