Trial Outcomes & Findings for Intimate Partner Violence and Fatherhood Intervention in Residential Substance Abuse Treatment (NCT NCT02979262)

NCT ID: NCT02979262

Last Updated: 2019-12-02

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 62 participants
• Primary outcome timeframe: Baseline and intervention completion around 16 weeks
• Results posted on: 2019-12-02

Participant Flow

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.

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.

Participant milestones

Measure	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	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
Overall Study STARTED	33	29
Overall Study Received Allocated Intervention	30	27
Overall Study COMPLETED	21	20
Overall Study NOT COMPLETED	12	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intimate Partner Violence and Fatherhood Intervention in Residential Substance Abuse Treatment

Baseline characteristics by cohort

Measure	Fathers for Change n=33 Participants 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	Parent Education (PE) n=29 Participants 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	Total n=62 Participants Total of all reporting groups
Age, Continuous	36.82 year STANDARD_DEVIATION 9.07 • n=5 Participants	34.76 year STANDARD_DEVIATION 6.28 • n=7 Participants	35.85 year STANDARD_DEVIATION 7.89 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	29 Participants n=7 Participants	62 Participants n=5 Participants
Race/Ethnicity, Customized Ethnic Minority	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants	29 participants n=7 Participants	62 participants n=5 Participants
Child Abuse History Physical Abuse History	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Child Abuse History Sexual Abuse History	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Child Abuse History Psychological Abuse History	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Current contact with partner	28 Participants n=5 Participants	26 Participants n=7 Participants	54 Participants n=5 Participants
Residence with target child before treatment	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Physical violence toward coparent	23 Participants n=5 Participants	22 Participants n=7 Participants	45 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Measure	Fathers for Change n=11 Participants 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	Parent Education (PE) n=21 Participants 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
Hostile Thoughts on the Articulated Thoughts in Simulated Situations Task Time 1-Baseline	8.00 score on a scale Standard Error 1.90	7.62 score on a scale Standard Error 1.38
Hostile Thoughts on the Articulated Thoughts in Simulated Situations Task Time 2 - 16 weeks	4.36 score on a scale Standard Error 1.43	4.23 score on a scale Standard Error 1.05

PRIMARY outcome

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

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.

Outcome measures

Measure	Fathers for Change n=33 Participants 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	Parent Education (PE) n=29 Participants 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
Change in Total Score of the Difficulties With Emotion Regulation Scale (DERS)	-.31 ratio score baseline to 28 weeks Standard Error .13	-.21 ratio score baseline to 28 weeks Standard Error .12

SECONDARY outcome

Timeframe: Baseline through 3 month follow-up after intervention

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.

Outcome measures

Measure	Fathers for Change n=33 Participants 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	Parent Education (PE) n=29 Participants 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
Change in Number of Domestic Violence Episodes on the Timeline Follow-Back Calendars	-.002 ratio score baseline to 28 weeks Standard Deviation .006	-.01 ratio score baseline to 28 weeks Standard Deviation .007

SECONDARY outcome

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

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.

Outcome measures

Measure	Fathers for Change n=33 Participants 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	Parent Education (PE) n=29 Participants 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
Change in Total Score on the Adult Adolescent Parenting Inventory	.12 ratio score baseline to 28 weeks Standard Error .07	.03 ratio score baseline to 28 weeks Standard Error .07

SECONDARY outcome

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

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.

Outcome measures

Measure	Fathers for Change n=33 Participants 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	Parent Education (PE) n=29 Participants 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
Change in Coparenting Relationship Scale	0.06 ratio score baseline to 28 weeks Standard Error .11	0.02 ratio score baseline to 28 weeks Standard Error .08

SECONDARY outcome

Timeframe: At 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.

Outcome measures

Measure	Fathers for Change n=33 Participants 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	Parent Education (PE) n=29 Participants 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
Change in Days of Substance Use Reported on the Time Line Follow-Back Calendars	.01 ratio score baseline to 28 weeks Standard Error .01	.03 ratio score baseline to 28 weeks Standard Error .03

Adverse Events

Fathers for Change

Serious events: 2 serious events

Other events: 10 other events

Deaths: 0 deaths

Parent Education (PE)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Fathers for Change n=33 participants at risk 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	Parent Education (PE) n=29 participants at risk 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
Psychiatric disorders Psychiatric hospitalization of child associated with study	3.0% 1/33 • Number of events 1 • Approximately 8 months	0.00% 0/29 • Approximately 8 months
Investigations Child Protective Services Report	3.0% 1/33 • Number of events 1 • Approximately 8 months	0.00% 0/29 • Approximately 8 months

Other adverse events

Measure	Fathers for Change n=33 participants at risk 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	Parent Education (PE) n=29 participants at risk 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
Social circumstances Participant Arrested and Jailed	30.3% 10/33 • Number of events 10 • Approximately 8 months	17.2% 5/29 • Number of events 5 • Approximately 8 months

Additional Information

Dr. Carla Stover

Yale University Child Study Center

Phone: 2037853486

Email: carla.stover@yale.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place