Intimate Partner Violence and Fatherhood Intervention in Residential Substance Abuse Treatment

Intimate Partner Violence Clinical Trial

Official title:

IPV and Fatherhood Intervention in Residential Substance Abuse Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02979262
• Other study ID #: 1R34DA038763-01A1
• Secondary ID: 1R34DA038763-01A
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: June 2018

Study information

• Verified date: November 2016
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Child Maltreatment
• Intimate Partner Violence
• Substance Abuse/Addiction
• Substance-Related Disorders

Intervention

Behavioral:
• Fathers for Change

• Parent Education

Locations

Country	Name	City	State
United States	Westcare Inc. Davis Bradley Building	Saint Petersburg	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of South Florida	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline and intervention completion around 16 weeks
Primary	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.	Baseline, intervention completion around 16 weeks, and 3 month post intervention around week 28
Secondary	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.	Baseline through 3 month follow-up after intervention
Secondary	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.	Baseline, intervention completion around 16 weeks, and 3 month post intervention around week 28
Secondary	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.	Baseline, intervention completion around 16 weeks, and 3 month post intervention around week 28
Secondary	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.	At intervention completion (around week 16) and 3 months post intervention (at around 28 weeks)