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临床试验/NCT06650267
NCT06650267招募中2 期

Substance Misuse and Family Violence Treatment for Fathers

Yale University4 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2025年2月17日最近更新:
干预措施

试验速览

阶段
2 期
状态
招募中
入组人数
280
试验地点
4
主要终点
Substance Misuse

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 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
  • agree to have their female coparents (mother of the youngest child) contacted for participation of their youngest child. If a participant has more than one child in the age range, the youngest will be the target of assessment and treatment.

排除标准

  • 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;
  • currently suicidal or homicidal based on Brief Symptom Inventory Screening and follow-up on positive responses; or
  • are currently receiving weekly individual therapy for Substance misuse or family violence

研究组 & 干预措施

Fathers for Change

Experimental

干预措施: Fathers for Change (F4C) (Behavioral)

Individual Drug Counseling

Active Comparator

干预措施: Individual Drug Counseling (IDC) (Behavioral)

结局指标

主要结局

Substance Misuse

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

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.

Family Violence (FV)

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

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

次要结局

  • Emotion Dysregulation(Baseline (week 0), Post-Treatment at week 19, week 32 and week 45)
  • Articulated Thoughts in Simulated Situations (ATSS)(Baseline (week 0) and Post-Treatment (week 18))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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