Back to resultsIntimate Partner Violence and Fatherhood Intervention in Residential Substance Abuse Treatment
Primary Purpose
Intimate Partner Violence, Substance Abuse/Addiction, Child Maltreatment
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fathers for Change
Parent Education
Sponsored by
About this trial
This is an interventional treatment trial for Intimate Partner Violence
Eligibility Criteria
Inclusion Criteria:
- 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.
Sites / Locations
- Westcare Inc. Davis Bradley Building
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Fathers for Change
Parent Education (PE)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Hostile Thoughts on the Articulated Thoughts in Simulated Situations Task
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. These are coded for number of hostile cognitions by trained blind coders and summed for a total score. The range of scores is 0 to 28 . Higher scores mean greater hostile cognitions (worse outcome).
Change in Total Score of the Difficulties With Emotion Regulation Scale (DERS)
Emotion regulation difficulties are measured using this standardized self-report measure and a total score is calculated by summing the items. Score range is 0 to 180 with higher scores meaning worse outcome. Change over time is reported as the slope.
Secondary Outcome Measures
Change in Number of Domestic Violence Episodes on the Timeline Follow-Back Calendars
Domestic Violence including physical and psychological aggression episodes across the length of followup. Higher scores mean more violence. Scores can range from 0 to 210 days. Change over time is reported as the slope.
Change in Total Score on the Adult Adolescent Parenting Inventory
Overall score is indicator of maltreatment risk. A total score is calculated by summing the 5 scales with lower scores indicating greater risk for maltreatment. The range of scores is from 40 to 200. Change over time is reported as the slope.
Change in Coparenting Relationship Scale
Brief Coparenting score which is calculated from a sum of 14 scale items. Scores range from 0 to 84 with higher scores indicating better coparenting. Change over time is reported as the slope.
Change in Days of Substance Use Reported on the Time Line Follow-Back Calendars
Number of days of substance use over the course of the study. Higher scores equal more days of substance use. Possible range of scores was from 0 to 210 days. Change over time is reported as the slope.
Full Information
NCT ID
NCT02979262
First Posted
October 4, 2016
Last Updated
November 12, 2019
Sponsor
University of South Florida
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT02979262
Brief Title
Intimate Partner Violence and Fatherhood Intervention in Residential Substance Abuse Treatment
Official Title
IPV and Fatherhood Intervention in Residential Substance Abuse Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Florida
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intimate Partner Violence, Substance Abuse/Addiction, Child Maltreatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fathers for Change
Arm Type
Experimental
Arm Description
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.
Arm Title
Parent Education (PE)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Fathers for Change
Intervention Type
Behavioral
Intervention Name(s)
Parent Education
Primary Outcome Measure Information:
Title
Hostile Thoughts on the Articulated Thoughts in Simulated Situations Task
Description
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. These are coded for number of hostile cognitions by trained blind coders and summed for a total score. The range of scores is 0 to 28 . Higher scores mean greater hostile cognitions (worse outcome).
Time Frame
Baseline and intervention completion around 16 weeks
Title
Change in Total Score of the Difficulties With Emotion Regulation Scale (DERS)
Description
Emotion regulation difficulties are measured using this standardized self-report measure and a total score is calculated by summing the items. Score range is 0 to 180 with higher scores meaning worse outcome. Change over time is reported as the slope.
Time Frame
Baseline, intervention completion around 16 weeks, and 3 month post intervention around week 28
Secondary Outcome Measure Information:
Title
Change in Number of Domestic Violence Episodes on the Timeline Follow-Back Calendars
Description
Domestic Violence including physical and psychological aggression episodes across the length of followup. Higher scores mean more violence. Scores can range from 0 to 210 days. Change over time is reported as the slope.
Time Frame
Baseline through 3 month follow-up after intervention
Title
Change in Total Score on the Adult Adolescent Parenting Inventory
Description
Overall score is indicator of maltreatment risk. A total score is calculated by summing the 5 scales with lower scores indicating greater risk for maltreatment. The range of scores is from 40 to 200. Change over time is reported as the slope.
Time Frame
Baseline, intervention completion around 16 weeks, and 3 month post intervention around week 28
Title
Change in Coparenting Relationship Scale
Description
Brief Coparenting score which is calculated from a sum of 14 scale items. Scores range from 0 to 84 with higher scores indicating better coparenting. Change over time is reported as the slope.
Time Frame
Baseline, intervention completion around 16 weeks, and 3 month post intervention around week 28
Title
Change in Days of Substance Use Reported on the Time Line Follow-Back Calendars
Description
Number of days of substance use over the course of the study. Higher scores equal more days of substance use. Possible range of scores was from 0 to 210 days. Change over time is reported as the slope.
Time Frame
At intervention completion (around week 16) and 3 months post intervention (at around 28 weeks)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Facility Information:
Facility Name
Westcare Inc. Davis Bradley Building
City
Saint Petersburg
State/Province
Florida
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Intimate Partner Violence and Fatherhood Intervention in Residential Substance Abuse Treatment
We'll reach out to this number within 24 hrs