跳至主要内容
临床试验/NCT06074068
NCT06074068招募中不适用

Examining Therapeutic Change Mechanisms in an Affect Regulation, Father-Focused Intervention for Reducing Family Violence and Associated Symptoms in Children

Yale University3 个研究点 分布在 1 个国家目标入组 1,080 人开始时间: 2024年1月11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
1,080
试验地点
3
主要终点
Change in Physical Intimate Partner Violence (IPV) overtime

研究概览

简要总结

The goal of this clinical trial is to test the efficacy of Fathers for Change (F4C) compared to standard Batterer Intervention for fathers with a history of Intimate Partner Violence. The main question[s] it aims to answer are:

  1. Is F4C more efficacious than standard BIP in reducing family violence and child mental health impairment?
  2. What are the trajectories of therapeutic change targets across interventions?
  3. Does father's emotion regulation and reflective functioning mediate the relationship between the two interventions and child-related outcomes? Participants will be randomized to either Fathers for Change on Batterer Intervention.

详细描述

Children's exposure to intimate partner violence (IPV), often perpetrated by fathers, has been described as a gateway to other adversity, with more than a 50% co-occurrence of direct forms of child maltreatment (CM). IPV exposure can wreak havoc on children, with risk for psychosocial impairments, including posttraumatic stress disorder (PTSD), that can emerge early and cascade across development. Lacking are interventions that adequately address the complex nature of IPV in families, including fatherhood and coparenting. This gap reflects a bias towards excluding offending fathers from child-focused work and an overreliance on batterer intervention programs (BIPs), which have shown negligible effects in meta-analyses and fail to address the roots of offending behaviors in fathers. Consequently, IPV exposed children remain at risk and fathers' personal and interpersonal functioning, including the father-child relationship, does not improve. In effect, there is an urgent need for effective interventions for fathers and their families. Fathers for Change (F4C) is a novel fatherhood-focused intervention with a dual focus on IPV and CM that focuses on identifying, understanding, and managing emotions to reduce aggression and improve partner and parent-child interactions. F4C has a growing evidence-base demonstrating significant reductions in family violence, improved father-child interactions, and in one open trial, improved child mental health. Proposed therapeutic mechanisms of F4C include reflective functioning (RF), the capacity for parents to understand their own and children's actions as a function of underlying states and motivations, and emotion regulation (ER), the capacity to exert control over emotional states and reactions to threat. Poor RF and ER have been associated with increased family violence and stress-related psychopathology, suggesting key focal points for intervention. To date, there have been no empirical examinations of ER and RF as therapeutic change mechanisms for reducing family violence and improving father-child interactions and child mental health. Proposed is a dual-site, multi-modal examination of ER and RF in fathers (of children 3 months through 12 years) randomized to F4C (N=140) or the Duluth Model (N=140), a BIP serving as active control. In-session observational coding will assess adaptive and maladaptive ER and RF across treatment. Weekly self-ratings will assess at-home ER and RF. Aims will (1) assess efficacy of F4C compared to a standard BIP in reducing family violence and child mental health impairment, (2) map and compare trajectories of therapeutic change targets across interventions, and (3) examine the mediating role of father's ER and RF on child-related outcomes. This proposal will grow the evidence-base for F4C and advance our understanding of therapeutic mechanisms through which F4C exerts its effects.

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
All
接受健康志愿者

入选标准

  • have at least one 6 month to 12-year-old biological child with whom they have contact;
  • had an incident of IPV within the last 12 months prior to screening with their child's mother (based on court/police records, coparent or self-report);
  • have a currently open or recently investigated (in the last 6 months) case with CT DCF
  • are able to complete assessments in English or Spanish;
  • agree to have their female coparents (mother of target child) contacted as collateral informants and for consent for participation of their child. If a participant has more than one child in the age range, the youngest will be selected;
  • female coparents (i.e., biological mother who need not be in a relationship with the father) consents to (at minimum) provide parent-report on child; however, may opt out of child participation. If the coparent agrees to participate by providing caregiver-report on child symptoms, but declines participation of their shared child, the father may still participate in the study if he meets eligibility criteria outlined below; thus, preventing any possible retaliation against co-parents for not consenting to child participation.

排除标准

  • Fathers will be excluded based on the following exclusion criteria:
  • an active full/no contact protective order pertaining to their child because this will preclude participation in the father-child play assessment (many men will have protective orders pertaining to their partners, but it is more common for men to still be allowed contact with their children);
  • physiological addiction to a substance that requires detoxification. Fathers will be evaluated using the Drug Abuse Screening Test and AUDIT. If fathers report significant difficulties with physiological withdrawal (e.g., alcohol tremors or dope sickness) they will be referred for detox services. They can be re-evaluated following a detox program with documentation from the detox center of successful completion and clean urine screen;
  • cognitive impairment that will not allow for understanding of the study interventions (a mini mental state score <25);
  • current untreated psychotic disorder;
  • currently suicidal or homicidal ideation based on screening using the BSI; or
  • previously participated in F4C or a BIP.

研究组 & 干预措施

Fathers for Change

Experimental

Defining features of F4C include: 1) focus on the fathering role to facilitate engagement, 2) focus on RF to understand self, partner and children and emotion regulation skills to reduce IPV and child maltreatment. F4C focuses on understanding of emotional experiences, how they impact thinking and behaviors related to partners, co-parents and children. F4C clients will meet individually with their F4C therapist for 60 minutes per week over 18 weeks.

干预措施: Fathers for Change (Behavioral)

Duluth BIP

Active Comparator

The BIP is a psychoeducational intervention that will be delivered in 60- minute individual weekly sessions over 18 weeks. The intervention focuses on the impact of violence on victims, power and control tactics, and societal influences supporting men's violence toward women. The intervention includes didactics and experiential exercises including video vignettes and role plays to teach anger management skills.

干预措施: Duluth BIP (Behavioral)

结局指标

主要结局

Change in Physical Intimate Partner Violence (IPV) overtime

时间窗: Baseline, 19 weeks, 43 weeks and 70 weeks

The Physical Intimate Partner Violence Subscale of the Family Socialization Interview-Revised will be used to assess physical IPV. Items are coded on a 4-point scale for severity from 0 (none) to 4 (severe). Scores are averaged to achieve a total score with a range of 0 to 4. Higher scores indicate greater frequency and severity of Physical IPV.

Change in Verbal Intimate Partner Violence (IPV) overtime

时间窗: Baseline, 19 weeks, 43 weeks and 70 weeks

The Verbal Intimate Partner Violence Subscale of the Family Socialization Interview-Revised will be used to assess verbal IPV. Items are coded on a 4-point scale for severity from 0 (none) to 4 (severe). Scores are averaged to achieve a final score with a range of 0 to 4. Higher scores indicate greater frequency and severity of verbal IPV.

Change in Physical Child Maltreatment overtime

时间窗: Baseline, 19 weeks, 43 weeks and 70 weeks

Family Socialization Interview-Revised will be used to assess physical child maltreatment. The Physical scale will be used for this outcome. Items are ranked on 0-4 point scale from 0 (none) to 4 (severe) and averaged for a final score with a range of 0 to 4 with higher scores indicating greater frequency and severity of physical child maltreatment risk.

Change in Verbal Child Maltreatment overtime

时间窗: Baseline, 19 weeks, 43 weeks and 70 weeks

Family Socialization Interview-Revised will be used to assess physical child maltreatment. The verbal scale will be used for this outcome. Items are ranked on 0-4 point scale from 0 (none) to 4 (severe) and averaged for a final score with a range of 0 to 4 with higher scores indicating greater frequency and severity of verbal child maltreatment risk.

次要结局

  • Change in Father-child interactions overtime(Baseline, 19 weeks, and 70 weeks)
  • Change in Coercive Controlling Intimate Partner Violence (IPV) overtime(Baseline, 19 weeks, 43 weeks and 70 weeks)
  • Change in Child Depression Symptoms(Baseline, 19 weeks, 43 weeks and 70 weeks)
  • Change in Child Anxiety Symptoms(Baseline, 19 weeks, 43 weeks and 70 weeks)
  • Change in Child Posttraumatic Stress Symptoms overtime(Baseline, 19 weeks, 43 weeks and 70 weeks)
  • Change in Child Aggression Symptoms(Baseline, 19 weeks, 43 weeks and 70 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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