NCT02979262

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 1, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

December 2, 2019

Completed
Last Updated

December 2, 2019

Status Verified

November 1, 2016

Enrollment Period

2.1 years

First QC Date

October 4, 2016

Results QC Date

March 26, 2019

Last Update Submit

November 12, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

  • Change in Number of Domestic Violence Episodes on the Timeline Follow-Back Calendars

    Baseline through 3 month follow-up after intervention

  • Change in Total Score on the Adult Adolescent Parenting Inventory

    Baseline, intervention completion around 16 weeks, and 3 month post intervention around week 28

  • Change in Coparenting Relationship Scale

    Baseline, intervention completion around 16 weeks, and 3 month post intervention around week 28

  • Change in Days of Substance Use Reported on the Time Line Follow-Back Calendars

    At intervention completion (around week 16) and 3 months post intervention (at around 28 weeks)

Study Arms (2)

Fathers for Change

EXPERIMENTAL

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

Parent Education (PE)

ACTIVE COMPARATOR

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

Interventions

Fathers for Change
Parent Education (PE)

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Westcare Inc. Davis Bradley Building

St. Petersburg, Florida, United States

Location

MeSH Terms

Conditions

Substance-Related DisordersBehavior, Addictive

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersCompulsive BehaviorImpulsive BehaviorBehavior

Results Point of Contact

Title
Dr. Carla Stover
Organization
Yale University Child Study Center

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2016

First Posted

December 1, 2016

Study Start

May 1, 2016

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

December 2, 2019

Results First Posted

December 2, 2019

Record last verified: 2016-11

Locations