Expired Study
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New Haven, Connecticut 06510


Purpose:

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.


Criteria:

Inclusion Criteria: 1. meet current DSM-IV criteria for substance abuse and who have used a substance within the 60 days prior to screening; 2. have a police reported incident of IPV (pushing, slapping, kicking) within 6 months of referral; 3. have at least one biological child under the age of 7 with whom they reside or have at least weekly visitation. Exclusion Criteria: 1. Have histories of severe physical violence (e.g. choking, causing hospitalization); 2. Men who have an active NO CONTACT protective order pertaining to their partner or child; 3. Men whose female partners indicate that they do not want the child to participate; 4. If the female partner indicates that she believes her child is afraid of his/her father and will NOT want to participate; 5. Men who are currently in withdrawal from substances and in need of detoxification; 6. Have cognitive impairment or a lifetime history of any psychotic or bipolar disorder; or 7. Are currently suicidal or homicidal.


Study is Available At:


Original ID:

1003006541


NCT ID:

NCT01385553


Secondary ID:

1K23DA023334-01A2


Study Acronym:


Brief Title:

Fathers for Change for Men With Co-occurring Domestic Violence and Substance Abuse


Official Title:

Randomized Trial of Fathers for Change: An Intervention for Fathers With Co-Occuring Domestic Violence and Substance Abuse


Overall Status:

Completed


Study Phase:

Phase 1/Phase 2


Genders:

Male


Minimum Age:

18 Years


Maximum Age:

60 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Yale University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Parall


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

20


Enrollment Type:

Actual


Overall Contact Information

Official Name:Carla S Stover, Ph.D.
Principal Investigator
Yale University

Study Dates

Start Date:June 2011
Completion Date:June 2013
Completion Type:Actual
Primary Completion Date:June 2013
Primary Completion Type:Actual
Verification Date:February 2014
Last Changed Date:February 18, 2014
First Received Date:June 14, 2011

Study Outcomes

Outcome Type:Primary Outcome
Measure:Decrease in Verbal and Physical Aggression
Time Frame:Baseline (Start of Tx), 4 month follow-up, 7 month follow-up
Safety Issues:True
Description:Conflict Tactics Scale and the TimeLine Follow-back calendar interview
Outcome Type:Primary Outcome
Measure:Decrease in Substance Abuse
Time Frame:weekly for months 1-4, 7 month followup
Safety Issues:True
Description:urinalysis results and self report
Outcome Type:Primary Outcome
Measure:Decrease in Negative Parenting Behavior
Time Frame:baseline, 4 month, 7 month follow-up
Safety Issues:True
Description:IOWA, Adult child relationship questionnaire, Parental Acceptance Rejection Questionnaire

Study Interventions

Intervention Type:Behavioral
Name:Fathers for Change
Description: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
Arm Name:Fathers for Change
Other Name:Integrated Father Treatment for Domestic Violence
Intervention Type:Behavioral
Name:Individual Drug Counseling
Description: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
Arm Name:Individual Drug Counseling
Other Name:IDC

Study Arms

Study Arm Type:Active Comparator
Arm Name:Individual Drug Counseling
Study Arm Type:Experimental
Arm Name:Fathers for Change

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Yale University
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute on Drug Abuse (NIDA)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation: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.
PMID:17364418

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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