ClinicalTrials.gov
ClinicalTrials.gov Menu

Intimate Partner Violence and Fatherhood Intervention in Residential Substance Abuse Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02979262
Recruitment Status : Unknown
Verified November 2016 by University of South Florida.
Recruitment status was:  Recruiting
First Posted : December 1, 2016
Last Update Posted : December 1, 2016
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of South Florida

Brief Summary:
The proposed stage 1 intervention development study is designed to address two significant co-occurring issues for fathers with substance abuse (SA) problems: Intimate partner violence (IPV) and child maltreatment (CM). SA treatment programs are an important avenue to reduce family violence because SA treatment alone does not result in an end to these behaviors. Currently available interventions have had little success in reducing male IPV. Fathers for Change, an integrated outpatient intervention, shows promise as an intervention model targeting the intersection of SA, IPV, and CM. The intervention uses men's roles as fathers as a motivation for change and targets factors that are known to trigger SA, IPV and CM: hostile cognitions and poor emotion regulation. An intervention of this sort has not been integrated and tested as part of a residential substance abuse program for men. This project is a pilot study of 60 fathers randomly assigned to Fathers for Change or a Parent Education Program (PE) comparison. The initial feasibility of the Fathers for Change will be assessed by comparing it to PE in the areas of: participant completion rates, hostile cognitions, emotion regulation, SA relapse, IPV, and CM risk behaviors (negative parenting). Change in hostile cognitions and emotion regulation will be examined as the mechanisms through which Fathers for Change reduces relapse, IPV and CM risk behaviors.

Condition or disease Intervention/treatment Phase
Intimate Partner Violence Substance Abuse/Addiction Child Maltreatment Behavioral: Fathers for Change Behavioral: Parent Education Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: IPV and Fatherhood Intervention in Residential Substance Abuse Treatment
Study Start Date : May 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Arm Intervention/treatment
Experimental: Fathers for Change
Fathers for Change treatment begins with individual-focused sessions followed by co-parenting focused sessions and ending with restorative parenting sessions. The areas of focus for each of the three phases of Fathers for Change are: 1) abstinence from SA and violence; 2) co-parenting; 3) parenting/father-child relationship. Treatment begins with motivational enhancement by focusing the role of men as fathers to their young children, child development and the impact of violence and SA on parenting, and the father's own childhood experiences of SA and violence to highlight the multigenerational nature of these problems. The program then focuses on skills training in the following areas: reducing automatic hostile cognitions and increasing emotion regulation skills, 2) communication and problem solving around co-parenting, and 3) restorative parenting.
Behavioral: Fathers for Change
Active Comparator: Parent Education (PE)
PE is an individual intervention.PE was developed to represent parent education and support that is typically available to parents with substance use problems who are at high risk for neglecting their children. Fathers enrolled in PE will meet weekly for one hour with a PE counselor who will provide assistance in solving problems related to family basic needs (e.g., health care, child care, housing and education). The PE counselor will provide a choice of pamphlets on age-related parenting topics each week from a series of pamphlets designed for work with substance abusing parents. Sample pamphlet topics include routines and rituals, ages and milestones, alternatives to spanking, and nutrition and fitness.
Behavioral: Parent Education



Primary Outcome Measures :
  1. Change in Total Hostile Thoughts on the Articulated Thoughts in Simulated Situations Task [ Time Frame: Baseline and intervention completion around 16 weeks ]
    Hostile Thinking coded from audio recorded transcripts. Participants are presented with 4 scenarios in which they are asked to respond verbally their thoughts about a given situation. The scenarios present incidents that could induce feelings of jealousy, anger, abandonment, or disrespect.

  2. Change in the total score on the Total Score of the Difficulties with Emotion Regulation Scale [ Time Frame: Baseline, intervention completion around 16 weeks, and 3 month post intervention around week 38 ]
    Emotion regulation difficulties are measured using this standardized self-report measure and a total score is calculated


Secondary Outcome Measures :
  1. Total days of domestic violence on the Timeline Follow Back interview [ Time Frame: Baseline, intervention completion around 16 weeks, and 3 month post intervention around week 38 ]
    Domestic Violence reported via a calendar interview to assess total days of physical, verbal or psychological aggression.

  2. Subscales of the Adult Adolescent Parenting Inventory [ Time Frame: Baseline, intervention completion around 16 weeks, and 3 month post intervention around week 38 ]
    4 subscales that assess risk factors for child maltreatment

  3. Coparenting Relationship Scale [ Time Frame: Baseline, intervention completion around 16 weeks, and 3 month post intervention around week 38 ]
  4. Urinalysis Panel-9 Drug urine screen for positive drug use [ Time Frame: At intervention completion (around week 16) and 3 months post intervention (at around 38 weeks) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. meet current DSM-5 criteria for substance use disorder of alcohol, cocaine, marijuana, amphetamines, or opiates at the time of admission to Westcare; (2) report physical violence in an intimate relationship (pushing, slapping, kicking) within 6 months of admission to the program (based on court/police records or self- report); and (3) have at least one biological child under the age of 12 with whom they lived or had at least once per month visitation prior to admission to Westcare. Each will agree to have their female co-parents contacted for participation as collateral informants and will provide the contact information. If a participant has more than one child in the age range, the youngest child will be the target of assessment. Female co-parents (the target children's mothers) will be invited to participate as collateral informants on research assessments and to participate in a portion (2 -4) of the intervention sessions. If a female co-parent does not consent to participate, a male participant will still be allowed to enroll in the study if he meets eligibility criteria

Exclusion Criteria:

  • Individuals will be excluded who: 1) Have histories of severe physical violence (e.g. strangulation, causing hospitalization) based on police records, self or partner reports; 2) Men who have an active FULL/NO CONTACT protective order pertaining to their partner or child (Westcare has access to criminal record/court information for all of it's residential clients. Participants will sign releases of information during informed consent to allow the study team to access this information to determine eligibility); 3) Have cognitive impairment (a mini mental state score <25); 4) Have major medical complications such as a head injury or HIV dementia that may also be a confound in the study interventions; 5) Have current untreated psychotic or bipolar disorder (reported by history, as part of the Westcare record, or self-report); or 6) Are currently suicidal or homicidal. If potential participants have a prior diagnosis of bipolar or psychotic disorder that is currently treated and symptoms are well managed based on initial study interview and after collateral contact with the Westcare treatment team, they may participate in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02979262


Contacts
Contact: Carla S Stover, Ph.D. 813-974-6019 carlastover@usf.edu

Locations
United States, Florida
Westcare Inc. Davis Bradley Building Recruiting
St. Petersburg, Florida, United States
Contact: Carla S Stover, Ph.D.    813-974-6019    carlastover@usf.edu   
Contact: Melissa Barongi, B.S.    813-974-4269      
Sponsors and Collaborators
University of South Florida
National Institute on Drug Abuse (NIDA)

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT02979262     History of Changes
Other Study ID Numbers: 1R34DA038763-01A1 ( U.S. NIH Grant/Contract )
First Posted: December 1, 2016    Key Record Dates
Last Update Posted: December 1, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders