Intimate Partner Violence and Fatherhood Intervention in Residential Substance Abuse Treatment

• Sponsor: University of South Florida (Other)
• Overall Status: Completed
• CT.gov ID: NCT02979262
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 62
• Location: 1
• Arms: 2
• Actual Duration (Months): 25
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intimate Partner Violence; Substance Abuse/Addiction; Child Maltreatment	Behavioral: Fathers for Change; Behavioral: Parent Education	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 62 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: IPV and Fatherhood Intervention in Residential Substance Abuse Treatment
• Actual Study Start Date: May 1, 2016
• Actual Primary Completion Date: Jun 1, 2018
• Actual Study Completion Date: Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
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.	Behavioral: Fathers for Change
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.	Behavioral: Parent Education

Outcome Measures

Primary Outcome Measures

1. Hostile Thoughts on the Articulated Thoughts in Simulated Situations Task [Baseline and intervention completion around 16 weeks]

   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).

2. 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 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.

Secondary Outcome Measures

1. Change in Number of Domestic Violence Episodes on the Timeline Follow-Back Calendars [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.

2. Change in Total Score on the Adult Adolescent Parenting Inventory [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.

3. Change in Coparenting Relationship Scale [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.

4. 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)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Westcare Inc. Davis Bradley Building	Saint Petersburg	Florida	United States

Sponsors and Collaborators

• University of South Florida
• National Institute on Drug Abuse (NIDA)

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Aug 14, 2017
• Statistical Analysis Plan - Mar 25, 2019

More Information

Publications

None provided.

• Responsible Party: University of South Florida
• ClinicalTrials.gov Identifier: NCT02979262
• Other Study ID Numbers: 1R34DA038763-01A1; 1R34DA038763-01A1
• First Posted: Dec 1, 2016
• Last Update Posted: Dec 2, 2019
• Last Verified: Nov 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Substance-Related Disorders

Study Results

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 Detail	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.

Arm/Group Title	Fathers for Change	Parent Education (PE)
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	33	29
Received Allocated Intervention	30	27
COMPLETED	21	20
NOT COMPLETED	12	9

Baseline Characteristics

Arm/Group Title	Fathers for Change	Parent Education (PE)	Total
Arm/Group Description	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	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 of all reporting groups
Overall Participants	33	29	62
Age (year) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [year]	36.82 (9.07)	34.76 (6.28)	35.85 (7.89)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	33 100%	29 100%	62 100%
Race/Ethnicity, Customized (Count of Participants)
Ethnic Minority	9 27.3%	7 24.1%	16 25.8%
Region of Enrollment (participants) [Number]
United States	33 100%	29 100%	62 100%
Child Abuse History (Count of Participants)
Physical Abuse History	6 18.2%	8 27.6%	14 22.6%
Sexual Abuse History	4 12.1%	2 6.9%	6 9.7%
Psychological Abuse History	6 18.2%	8 27.6%	14 22.6%
Current contact with partner (Count of Participants)
Count of Participants [Participants]	28 84.8%	26 89.7%	54 87.1%
Residence with target child before treatment (Count of Participants)
Count of Participants [Participants]	11 33.3%	10 34.5%	21 33.9%
Physical violence toward coparent (Count of Participants)
Count of Participants [Participants]	23 69.7%	22 75.9%	45 72.6%

Outcome Measures

1. Primary Outcome

Title	Hostile Thoughts on the Articulated Thoughts in Simulated Situations Task
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Fathers for Change	Parent Education (PE)
Arm/Group Description	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	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
Measure Participants	11	21
Time 1-Baseline	8.00 (1.90)	7.62 (1.38)
Time 2 - 16 weeks	4.36 (1.43)	4.23 (1.05)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fathers for Change, Parent Education (PE)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>.10
	Comments
	Method	Repeated Measures GLM
	Comments	Time 2 at 16 weeks

2. Primary Outcome

Title	Change in Total Score of the Difficulties With Emotion Regulation Scale (DERS)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fathers for Change	Parent Education (PE)
Arm/Group Description	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	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
Measure Participants	33	29
Mean (Standard Error) [ratio score baseline to 28 weeks]	-.31 (.13)	-.21 (.12)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fathers for Change, Parent Education (PE)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<.01
	Comments
	Method	GEE
	Comments

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fathers for Change	Parent Education (PE)
Arm/Group Description	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	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
Measure Participants	33	29
Mean (Standard Deviation) [ratio score baseline to 28 weeks]	-.002 (.006)	-.01 (.007)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fathers for Change, Parent Education (PE)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>.10
	Comments
	Method	GEE
	Comments

4. Secondary Outcome

Title	Change in Total Score on the Adult Adolescent Parenting Inventory
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fathers for Change	Parent Education (PE)
Arm/Group Description	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	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
Measure Participants	33	29
Mean (Standard Error) [ratio score baseline to 28 weeks]	.12 (.07)	.03 (.07)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fathers for Change, Parent Education (PE)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>.10
	Comments
	Method	GEE
	Comments

5. Secondary Outcome

Title	Change in Coparenting Relationship Scale
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fathers for Change	Parent Education (PE)
Arm/Group Description	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	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
Measure Participants	33	29
Mean (Standard Error) [ratio score baseline to 28 weeks]	0.06 (.11)	0.02 (.08)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fathers for Change, Parent Education (PE)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>.10
	Comments
	Method	GEE
	Comments

6. Secondary Outcome

Title	Change in Days of Substance Use Reported on the Time Line Follow-Back Calendars
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fathers for Change	Parent Education (PE)
Arm/Group Description	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	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
Measure Participants	33	29
Mean (Standard Error) [ratio score baseline to 28 weeks]	.01 (.01)	.03 (.03)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fathers for Change, Parent Education (PE)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<.01
	Comments
	Method	GEE
	Comments

Adverse Events

Time Frame	Approximately 8 months
Arm/Group Title	Fathers for Change		Parent Education (PE)
Arm/Group Description	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		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
All Cause Mortality
	Fathers for Change		Parent Education (PE)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/29 (0%)
Serious Adverse Events
	Fathers for Change		Parent Education (PE)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/33 (6.1%)		0/29 (0%)
Investigations
Child Protective Services Report	1/33 (3%)	1	0/29 (0%)	0
Psychiatric disorders
Psychiatric hospitalization of child associated with study	1/33 (3%)	1	0/29 (0%)	0
Other (Not Including Serious) Adverse Events
	Fathers for Change		Parent Education (PE)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/33 (30.3%)		5/29 (17.2%)
Social circumstances
Participant Arrested and Jailed	10/33 (30.3%)	10	5/29 (17.2%)	5

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.