- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02979262
Intimate Partner Violence and Fatherhood Intervention in Residential Substance Abuse Treatment
November 12, 2019 updated by: University of South Florida
IPV and Fatherhood Intervention in Residential Substance Abuse Treatment
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
62
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Saint Petersburg, Florida, United States
- Westcare Inc. Davis Bradley Building
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hostile Thoughts on the Articulated Thoughts in Simulated Situations Task
Time Frame: Baseline and intervention completion around 16 weeks
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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).
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Baseline and intervention completion around 16 weeks
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Change in Total Score of the Difficulties With Emotion Regulation Scale (DERS)
Time Frame: Baseline, intervention completion around 16 weeks, and 3 month post intervention around week 28
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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.
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Baseline, intervention completion around 16 weeks, and 3 month post intervention around week 28
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Number of Domestic Violence Episodes on the Timeline Follow-Back Calendars
Time Frame: Baseline through 3 month follow-up after intervention
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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.
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Baseline through 3 month follow-up after intervention
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Change in Total Score on the Adult Adolescent Parenting Inventory
Time Frame: Baseline, intervention completion around 16 weeks, and 3 month post intervention around week 28
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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.
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Baseline, intervention completion around 16 weeks, and 3 month post intervention around week 28
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Change in Coparenting Relationship Scale
Time Frame: Baseline, intervention completion around 16 weeks, and 3 month post intervention around week 28
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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.
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Baseline, intervention completion around 16 weeks, and 3 month post intervention around week 28
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Change in Days of Substance Use Reported on the Time Line Follow-Back Calendars
Time Frame: At intervention completion (around week 16) and 3 months post intervention (at around 28 weeks)
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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.
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At intervention completion (around week 16) and 3 months post intervention (at around 28 weeks)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 1, 2016
Primary Completion (ACTUAL)
June 1, 2018
Study Completion (ACTUAL)
June 1, 2018
Study Registration Dates
First Submitted
October 4, 2016
First Submitted That Met QC Criteria
November 28, 2016
First Posted (ESTIMATE)
December 1, 2016
Study Record Updates
Last Update Posted (ACTUAL)
December 2, 2019
Last Update Submitted That Met QC Criteria
November 12, 2019
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R34DA038763-01A1 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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