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Intimate Partner Violence and Fatherhood Intervention in Residential Substance Abuse Treatment

IPV and Fatherhood Intervention in Residential Substance Abuse Treatment

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02979262
Enrollment
62
Registered
2016-12-01
Start date
2016-05-31
Completion date
2018-06-30
Last updated
2019-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intimate Partner Violence, Substance Abuse/Addiction, Child Maltreatment

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.

Interventions

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
University of South Florida
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Hostile Thoughts on the Articulated Thoughts in Simulated Situations TaskBaseline and intervention completion around 16 weeksHostile 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)Baseline, intervention completion around 16 weeks, and 3 month post intervention around week 28Emotion 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

MeasureTime frameDescription
Change in Number of Domestic Violence Episodes on the Timeline Follow-Back CalendarsBaseline through 3 month follow-up after interventionDomestic 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 InventoryBaseline, intervention completion around 16 weeks, and 3 month post intervention around week 28Overall 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 ScaleBaseline, intervention completion around 16 weeks, and 3 month post intervention around week 28Brief 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 CalendarsAt intervention completion (around week 16) and 3 months post intervention (at around 28 weeks)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.

Countries

United States

Participant flow

Recruitment details

Fathers were recruited from two 6-month men's residential substance use treatment facilities. Both programs followed a 12-step facilitation therapeutic milieu approach. Information about the study was provided by facility staff to men who entered the facility, completed 30 days of treatment and had a biological child under the age of 16.

Pre-assignment details

Screening: 1) had some contact with his children via phone, letters or in person visits; 2) reported either physical or psychological aggression toward his female co-parent in the last 12 months; and 3) could complete study interviews and intervention in English. Eligible men met individually with an RA to complete baseline measures.

Participants by arm

ArmCount
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. Fathers for Change
33
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. Parent Education
29
Total62

Baseline characteristics

CharacteristicFathers for ChangeParent Education (PE)Total
Age, Continuous36.82 year
STANDARD_DEVIATION 9.07
34.76 year
STANDARD_DEVIATION 6.28
35.85 year
STANDARD_DEVIATION 7.89
Child Abuse History
Physical Abuse History
6 Participants8 Participants14 Participants
Child Abuse History
Psychological Abuse History
6 Participants8 Participants14 Participants
Child Abuse History
Sexual Abuse History
4 Participants2 Participants6 Participants
Current contact with partner28 Participants26 Participants54 Participants
Physical violence toward coparent23 Participants22 Participants45 Participants
Race/Ethnicity, Customized
Ethnic Minority
9 Participants7 Participants16 Participants
Region of Enrollment
United States
33 participants29 participants62 participants
Residence with target child before treatment11 Participants10 Participants21 Participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants
Sex: Female, Male
Male
33 Participants29 Participants62 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 330 / 29
other
Total, other adverse events
10 / 335 / 29
serious
Total, serious adverse events
2 / 330 / 29

Outcome results

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.

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

ArmMeasureValue (MEAN)Dispersion
Fathers for ChangeChange in Total Score of the Difficulties With Emotion Regulation Scale (DERS)-.31 ratio score baseline to 28 weeksStandard Error 0.13
Parent Education (PE)Change in Total Score of the Difficulties With Emotion Regulation Scale (DERS)-.21 ratio score baseline to 28 weeksStandard Error 0.12
p-value: <0.01GEE
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).

Time frame: Baseline and intervention completion around 16 weeks

Population: Participants completed this assessment at baseline and 16 weeks only. We had some participants who refused to complete this specific measure at the post assessment and therefore we have less participants for analysis.

ArmMeasureGroupValue (MEAN)Dispersion
Fathers for ChangeHostile Thoughts on the Articulated Thoughts in Simulated Situations TaskTime 1-Baseline8.00 score on a scaleStandard Error 1.9
Fathers for ChangeHostile Thoughts on the Articulated Thoughts in Simulated Situations TaskTime 2 - 16 weeks4.36 score on a scaleStandard Error 1.43
Parent Education (PE)Hostile Thoughts on the Articulated Thoughts in Simulated Situations TaskTime 1-Baseline7.62 score on a scaleStandard Error 1.38
Parent Education (PE)Hostile Thoughts on the Articulated Thoughts in Simulated Situations TaskTime 2 - 16 weeks4.23 score on a scaleStandard Error 1.05
p-value: >0.1Repeated Measures GLM
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.

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

ArmMeasureValue (MEAN)Dispersion
Fathers for ChangeChange in Coparenting Relationship Scale0.06 ratio score baseline to 28 weeksStandard Error 0.11
Parent Education (PE)Change in Coparenting Relationship Scale0.02 ratio score baseline to 28 weeksStandard Error 0.08
p-value: >0.1GEE
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.

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

ArmMeasureValue (MEAN)Dispersion
Fathers for ChangeChange in Days of Substance Use Reported on the Time Line Follow-Back Calendars.01 ratio score baseline to 28 weeksStandard Error 0.01
Parent Education (PE)Change in Days of Substance Use Reported on the Time Line Follow-Back Calendars.03 ratio score baseline to 28 weeksStandard Error 0.03
p-value: <0.01GEE
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.

Time frame: Baseline through 3 month follow-up after intervention

ArmMeasureValue (MEAN)Dispersion
Fathers for ChangeChange in Number of Domestic Violence Episodes on the Timeline Follow-Back Calendars-.002 ratio score baseline to 28 weeksStandard Deviation 0.006
Parent Education (PE)Change in Number of Domestic Violence Episodes on the Timeline Follow-Back Calendars-.01 ratio score baseline to 28 weeksStandard Deviation 0.007
p-value: >0.1GEE
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.

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

ArmMeasureValue (MEAN)Dispersion
Fathers for ChangeChange in Total Score on the Adult Adolescent Parenting Inventory.12 ratio score baseline to 28 weeksStandard Error 0.07
Parent Education (PE)Change in Total Score on the Adult Adolescent Parenting Inventory.03 ratio score baseline to 28 weeksStandard Error 0.07
p-value: >0.1GEE

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026