跳至主要内容
临床试验/NCT06526247
NCT06526247招募中不适用

Evaluating Interventions for Intimate Partner Violence Use in Washington State

Boston University2 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2024年11月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
800
试验地点
2
主要终点
IPV assessment

研究概览

简要总结

Intimate partner violence (IPV), specifically physical and psychological aggression toward an intimate partner, represents a public health crisis that affects millions of Americans each year. There currently exists very little evidence from randomized controlled trials for the effectiveness of abuser intervention programs designed to prevent and end perpetration of IPV in the general population. This is troubling considering that approximately half a million men and women are court-mandated to these programs each year.

The investigators will conduct a randomized controlled non-inferiority trial evaluating the effectiveness of the Strength at Home (SAH) intervention in reducing intimate partner violence (IPV). The overarching aim of this study is to determine whether outcomes achieved through SAH are non-inferior to those achieved through standard IPV interventions offered in the state of Washington (treatment as usual; TAU) among court-involved men who have used IPV.

The specific aims are:

1.1: Compare the frequency of physical and psychological IPV, the primary outcomes of interest, across conditions as reported by the male participants and their intimate partners across Time 1 (baseline) and four 3-month follow ups (Times 2-5). It is expected that reductions in physical and psychological IPV perpetration observed in SAH will be non-inferior to those observed in TAU over the course of the year.

1.2: Compare symptoms of PTSD, alexithymia, and alcohol use problems across conditions and assessment time points as reported by the male participants. It is expected that reductions in PTSD symptoms, alexithymia, and alcohol use problems observed in SAH will be non-inferior to those observed in TAU over the course of the year.

1.3: Compare treatment satisfaction across conditions as reported by the male participants across the four 3-month follow ups (Times 2-5). It is expected that treatment satisfaction in SAH will be comparable to or greater than treatment satisfaction in TAU.

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
None

入排标准

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

入选标准

  • Identify as a man
  • Provide consent for the research team to contact his intimate partner(s) for data collection purposes;
  • Court-referred for IPV intervention in Washington state
  • Identify as a woman
  • Were or currently are an intimate partner involved in an incident of IPV with a court-referred participant

排除标准

  • demonstrates active psychosis that may interfere with their ability to participate in group
  • expresses prominent suicidal or homicidal ideation that requires hospitalization
  • does not possess proficiency in spoken English
  • periods of incarceration after study enrollment

研究组 & 干预措施

Treatment as Usual (TAU)

Active Comparator

Participants randomized into this arm with receive a standard IPV intervention program in the state of Washington.

干预措施: Treatment as usual for IPV (Behavioral)

Strength at Home (SAH)

Experimental

Participants randomized into this arm with receive a trauma-informed intimate partner violence (IPV) intervention program.

干预措施: Strength at Home (SAH) (Behavioral)

结局指标

主要结局

IPV assessment

时间窗: Baseline, 3 months, 6 months. 9 months, 12 months

The revised Conflict Tactics Scales (CTS2), a 20-item instrument, will be used to assess IPV. The Physical Assault (12 items) and Psychological Aggression (8 items) subscales will be administered. Each of the 20 items is scored by the frequency of occurrence of the item with 8 choices 1-7 and 0.

Psychological IPV assessment

时间窗: Baseline, 3 months, 6 months. 9 months, 12 months

The 7-item Restrictive Engulfment subscale of the Multidimensional Measure of Emotional Abuse (MMEA) will be used as an additional measure of psychological IPV. Each item has 7 potential responses from 0=never to 6= more than 20 times. Scores can range from 0 to 42, with higher scores being associated with more psychological IPV.

Post Traumatic Stress Disorder (PTSD) symptoms

时间窗: Baseline, 3 months, 6 months. 9 months, 12 months

The 20-item PTSD Checklist for DSM 5 (PCL-5) will be used to assess PTSD symptoms. It is a self-report measure. Items are rated on a 5-point Likert scale \[0 to 4\] and summed. Scores range from 0 to 80 with higher scores associated with more PTSD symptoms. A total score of 33 or higher may indicate severe PTSD.

Alcohol use

时间窗: Baseline, 3 months, 6 months. 9 months, 12 months

The 10-item Alcohol Use Disorders Identification Test (AUDIT) will be used to assess problem drinking behavior over the past six months, with higher scores reflecting greater alcohol misuse.

Alexithymia assessment

时间窗: Baseline, 3 months, 6 months. 9 months, 12 months

The 20-itemToronto Alexithymia Scale (TAS-20) will be used to assess alexithymia. The TAS-20 uses cutoff scoring, with scores of 52-60 indicating possible alexithymia, and scores above 60 indicating alexithymia.

次要结局

  • Treatment Satisfaction(3 months, 6 months. 9 months, 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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