Health TrialsbyHealthPanel

Substance Misuse and Family Violence Treatment Fathers

ConditionsSubstance MisuseViolence, DomesticChild Abuse
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorYale University

About this trial

This study involves a randomized controlled trial of Fathers for Change (F4C) compared to Individual Drug Counseling (IDC) with a sample of 280 fathers enrolled in substance use (SU) treatment within community or veterans (VA) healthcare settings to (a) demonstrate F4C efficacy compared to IDC in reducing SU and family violence (FV) at end of treatment, 3- and 6-month post-treatment follow-up, and (b) document improved emotion regulation as the mechanism within F4C that results in reduced SU and FV.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

meet DSM-5 criteria for an SU disorder at the time of assessment at APT or VACHS;

report FV within the last 18 months prior to screening (based on self, court, police or child protection reports);

have at least one biological child aged 1 to 12 years with whom they live or have at least twice per month in person visits;

are able to complete assessments in English; and

Disqualifiers

an active full/no contact protective order pertaining to their child;

physiological addiction to a substance that requires detoxification (such individuals may be re-evaluated following detox);

cognitive impairment (a mini mental state score <25);

current untreated psychotic/bipolar disorder;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fathers for Change (F4C)

    Behavioral

    Defining features of F4C delivered over 18 sessions: 1) focus on the fathers model of fatherhood as a motivator for change, 2) focus on understanding and identifying feelings, teaching skills to identify and change emotional dysregulation that lead to both SU and FV, 3) co-parent communication skills to reduce stress and improve problem solving, 4) restorative parenting (see Table 1 and figure 1)127. F4C focuses on reflective understanding of emotional experiences, how that impacts thoughts and behaviors related to SU, FV, co-parenting/parenting each session. Through greater self-awareness, the father is better able to apply coping, communication and parenting skills introduced to reduce SU and FV.

  • Individual Drug Counseling (IDC)

    Behavioral

    IDC is an individual evidence-based SU treatment84 that incorporates two elements: endorsement of the disease model and the spiritual dimensions of recovery. These elements differentiate the approach from F4C. IDC is influenced by 12-step recovery philosophy and participation in 12-step groups like NA are encouraged. The model places focus on the individual in recovery without a focus on fatherhood or co-parenting. IDC will be offered in an 18-session format.

Treatment groups

280 Participants
are divided into 2 treatment groups
Group A: Fathers for ChangeExperimental treatment 1 intervention
Group B: Individual Drug CounselingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Substance Misuse

Self-reported days of substance misuse reported a positive breathalyzer/urine tox screen will be used to create a sum of the number of weeks with use during treatment and at each follow-up period.

Time frame
Baseline (week 0), weekly during treatment for through 18 week, Post-Treatment at week 19, week 32 and week 45
2

Family Violence (FV)

Any instance of FV either toward a partner or child identified by any report (self-report on the Timeline Followback weekly surveys, child protection or arrest record) will be counted to allow for the best estimate of FV across reports resulting in a sum count of the number of FV incidents during the 18 weeks of treatment and from post-treatment to each follow-up timepoint

Time frame
Baseline (week 0), weekly during treatment for through 18 week, Post-Treatment at week 19, week 32 and week 45

Secondary outcomes

1

Emotion Dysregulation

The Difficulties in Emotion Regulation Scale will be used to measure self-reported emotion regulation. Sum scores range from 18 to 90 with higher scores suggesting more impaired emotion regulation.

Time frame
Baseline (week 0), Post-Treatment at week 19, week 32 and week 45
2

Articulated Thoughts in Simulated Situations (ATSS)

The participants responses to the ATSS will be coded for hostile responding and will serve as a non-self-report measure of emotion regulation. Scores range from 0 to 5 with 5 being greater hostile responding across scenarios.

Time frame
Baseline (week 0) and Post-Treatment (week 18)

Other outcomes

Sponsors and contacts

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Yale University

Lead sponsor

APT Foundation, Inc.

Collaborator

VA Connecticut Healthcare System

Collaborator

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov
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