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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34DA038763-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fathers for Change | Behavioral |
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| Parent Education |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline through 3 month follow-up after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Westcare Inc. Davis Bradley Building | St. Petersburg | Florida | United States |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 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. | Posted | Mean | Standard Error | score on a scale | Baseline and intervention completion around 16 weeks |
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Approximately 8 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psychiatric hospitalization of child associated with study | Psychiatric disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Participant Arrested and Jailed | Social circumstances | Systematic Assessment | Arrest due to probation violation, new drug charge or other reason resulting in jail time. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carla Stover | Yale University Child Study Center | 2037853486 | carla.stover@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 14, 2017 | Apr 29, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 25, 2019 | Apr 29, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D016739 | Behavior, Addictive |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
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| 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. | Baseline, intervention completion around 16 weeks, and 3 month post intervention around week 28 |
| 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. | 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 | 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. | At intervention completion (around week 16) and 3 months post intervention (at around 28 weeks) |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| year |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Child Abuse History | Count of Participants | Participants |
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| Current contact with partner | Count of Participants | Participants |
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| Residence with target child before treatment | Count of Participants | Participants |
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| Physical violence toward coparent | Count of Participants | Participants |
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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
| OG001 | 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 |
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| 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. | Posted | Mean | Standard Error | ratio score baseline to 28 weeks | Baseline, intervention completion around 16 weeks, and 3 month post intervention around week 28 |
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| 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. | Posted | Mean | Standard Deviation | ratio score baseline to 28 weeks | Baseline through 3 month follow-up after intervention |
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| 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. | Posted | Mean | Standard Error | ratio score baseline to 28 weeks | Baseline, intervention completion around 16 weeks, and 3 month post intervention around week 28 |
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| 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. | Posted | Mean | Standard Error | ratio score baseline to 28 weeks | Baseline, intervention completion around 16 weeks, and 3 month post intervention around week 28 |
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| 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. | Posted | Mean | Standard Error | ratio score baseline to 28 weeks | At intervention completion (around week 16) and 3 months post intervention (at around 28 weeks) |
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| 0 |
| 33 |
| 2 |
| 33 |
| 10 |
| 33 |
| EG001 | 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 | 0 | 29 | 0 | 29 | 5 | 29 |
| Child Protective Services Report | Investigations | Non-systematic Assessment | Father in the study reported child neglect of his children who were in the care of his step-father prompting a child protective services report. |
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| D001519 |
| Behavior |