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NCT01385553 · ClinicalTrials.gov registry record · Phase 1

Fathers for Change for Men With Co-occurring Domestic Violence and Substance Abuse

A Phase 1 study, sponsored by Yale University.

Completed
Registry status
Phase 1
Development phase
20
Enrollment target

NCT01385553: Completed Phase 1 study, sponsored by Yale University.

NCT01385553 is a Phase 1 study that has completed, run by Yale University. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01385553, a Phase 1 study, has completed, sponsored by Yale University.

COMPLETED
Registry status
Phase 1
Development phase
20 participants
Enrollment target

Study Summary

Social service systems rarely acknowledge the status of men as fathers in the conceptualization and delivery of treatment for substance abuse or domestic violence. Although there has been extensive focus on the treatment of mothers who abuse substances, are victims of intimate partner violence (IPV) (defined as physical aggression and/or psychological abuse and control at the hands of an intimate partner), or maltreat their children there has been little consideration of the need for interventions for fathers with histories of co-morbid IPV and substance abuse. It is estimated that between 10 and 17.8 million children are witness to violence in their homes each year. National and regional samples indicate 50-70% of families impacted by IPV and the typically co-occurring substance abuse have children under the age of seven. Large percentages of these men continue to live with or have consistent contact with their young children despite aggression and substance use. Court mandated treatments for perpetrators of domestic violence have become the norm, however the efficacy of these treatments is questionable and most do not speak to the broader needs of batterers and their families. How batterer's treatments might impact parenting and father-child relationships and the psychosocial functioning of children is vastly understudied and not currently understood. Since batterer treatments are court mandated and require tremendous financial and community resources, the efficacy of these interventions in stopping the cycle of domestic violence and improving the health and well-being of the batterer, his partner and children is crucial. There are currently NO evidence-based treatments that address co-morbid substance abuse and domestic violence perpetration with emphasis on paternal parenting and the father-child relationship. Consequently, the proposed psychotherapy development project will develop and evaluate the potential efficacy of a novel, relational parent intervention

Primary Outcome

Conflict Tactics Scale and the TimeLine Follow-back calendar interview

Interventions

  • BEHAVIORAL Fathers for Change
  • BEHAVIORAL Individual Drug Counseling

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2011-06
Est. Completion 2013-06
Phase Phase 1
Yale University

1,492 total trials

What the finished NCT01385553 record still lists

NCT01385553 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).

The record links to 0 conditions, and to 2 interventions - of which Fathers for Change is the first listed.

NCT01385553 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01385553 about?

NCT01385553 is a clinical study titled "Fathers for Change for Men With Co-occurring Domestic Violence and Substance Abuse". Social service systems rarely acknowledge the status of men as fathers in the conceptualization and delivery of treatment for substance abuse or domestic violence. Although there has been extensive focus on the treatment of mothers who abuse substances, are victims of intimate partner violence (IPV)...

What is the current status of trial NCT01385553?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2011-06. Estimated completion is 2013-06.

What interventions are being tested in trial NCT01385553?

The interventions under investigation include: Fathers for Change (BEHAVIORAL), Individual Drug Counseling (BEHAVIORAL).

Who is sponsoring clinical trial NCT01385553?

This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01385553's enrollment target sits among peer trials

20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01385553, the US trial registry maintained by the National Library of Medicine. NCT01385553 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.