Randomized Controlled Trial of a Multi-pronged Intervention to Address Prevention of Violence in Zambia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 626
- 试验地点
- 1
- 主要终点
- Change in violence against women as measured by Severity of Violence Against Women Scale (SVAWS)
研究概览
简要总结
This study evaluates the effectiveness of a multi-pronged intervention in reducing and preventing violence against women and children compared to a treatment as usual control group among families living in Lusaka, Zambia.
详细描述
Aims:
- To test the effectiveness of a multi-pronged intervention in reducing and preventing violence against women and children compared to a treatment as usual control group among families living in Lusaka, Zambia.
- To test the effectiveness of a multi-pronged intervention compared to a treatment as usual control group in reducing identified risk factors of violence including alcohol use, mental health problems, poor parenting skills, and family communication and behavior patterns.
Design Overview:
This is a randomized controlled trial to evaluate the effectiveness of a multipronged intervention in reducing violence against women and girls/youth (VAWG) by addressing a number of identified risk factors (e.g., childhood abuse, domestic violence, alcohol use). 168 families from compounds (i.e. communities) in the city of Lusaka will be randomized to either control or experimental condition. An adult male, adult female, and one child from each family will be a "unit" and participate in the study. Child participation is optional (i.e., the adult male and female in the family unit may participate if they don't have children or do not provide permission for a child to participate).
The experimental intervention, a cognitive behavioral therapy-based psychotherapy (CETA) focuses on alcohol abuse and gender-specific violence, and addresses mental health, abuse, parenting skills, family communication and behavior patterns. There may be conjoint sessions that include both caregiver(s) and child(ren), when and if possible. During the 4-5 month intervention period there will be three group sessions per week: one for a male group, one group for women, and one group for children. Each counseling group will have approximately six group members. The intervention is designed this way due to research supporting multi-modal treatments, and to model how organizations are likely to incorporate a program to prevent violence into its regular services (i.e., group-based vs. individual sessions). The primary outcomes of the study are severity of violence against women and children. Secondary outcomes include alcohol use aggression, mental and behavioral health and gender norms.
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
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Families living in the study compounds in Lusaka (i.e., not staying temporarily)
- •Speaking one of the three study languages: English, Bemba, or Nyanja
- •Having at least one male adult and one female adult 18 years of age or older and in a relationship (married or dating) and one child between the ages of 8 to 17 identified by the mother as the most affected by the violence (if multiple children in the home). Child participation is optional.
- •The man and woman must both provide consent. If the female agree to have the child participate and the child wants to participate, then parental permission and child assent will be required.
- •The adult female must indicate during the inclusion screening at least a moderate amount of violence within the family as measured by scoring a 38 or more on the Severity of Violence Against Women Scale (SVAWS).
- •The male in the family must indicate that he drinks alcohol at hazardous levels or the female must report that the male drinks alcohol at hazardous levels as evidenced by scoring an 8 or higher on the Alcohol Use Disorders Identification Test (AUDIT).
排除标准
- •Any of the family members is currently on an unstable psychiatric drug regimen (i.e., regimen altered in last 2 months)
- •Any of the family members has had a suicide attempt or suicidal ideation with intent or plan, or self-harm in the past month.
- •Any of the family members has been diagnosed with a current psychotic disorder (identified by the University Teaching Hospital Psychiatric Unit).
- •Any of the family members has a serious developmental disorder (e.g., mental retardation, autism) that would preclude participation in cognitive-behavioral oriented skills intervention
研究组 & 干预措施
CETA
Participants in the experimental arm will receive the CETA intervention. The intervention period will last for approximately 4 months with weekly sessions. There will be separate groups for men, women, and children. Each group will have approximately six participants. Individuals who cannot attend group therapy (e.g., conflicting work schedules) may be offered the therapy individually.
干预措施: CETA (Behavioral)
Treatment as usual
There is no standard of care for domestic violence or alcohol use problems in Zambia. We will track any treatment or care that families receive during the course of the study. The active comparator arm will not receive any formal services provided by the study.
干预措施: Treatment as usual (Behavioral)
结局指标
主要结局
Change in violence against women as measured by Severity of Violence Against Women Scale (SVAWS)
时间窗: Baseline, 4-5 months post-baseline, 12 months post-baseline, 24 months post-baseline
次要结局
- Change in alcohol abuse as measured by the Alcohol Use Disorders Identification Test (AUDIT)(Baseline, 4-5 months post-baseline, 12 months post-baseline, 24 months post-baseline)
- Change in child internalizing and externalizing symptoms as measured by the Youth Self Report (YSR)(Baseline, 4-5 months post-baseline, 12 months post-baseline, 24 months post-baseline)
- Change in substance use as measured by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST)(Baseline, 4-5 months post-baseline, 12 months post-baseline, 24 months post-baseline)
- Change in child aggression as measured by the Child Aggression Scale(Baseline, 4-5 months post-baseline, 12 months post-baseline, 24 months post-baseline)
- Change in depression symptoms as measured by the Center for Epidemiological Studies Depression Scale (CES-D)(Baseline, 4-5 months post-baseline, 12 months post-baseline, 24 months post-baseline)
- Change in PTSD symptoms (adult) as measured by the Harvard Trauma Questionnaire (HTQ)(Baseline, 4-5 months post-baseline, 12 months post-baseline, 24 months post-baseline)
- Change in PTSD symptoms (child) as measured by the Child PTSD Symptom Scale (CPSS)(Baseline, 4-5 months post-baseline, 12 months post-baseline, 24 months post-baseline)
- Change in chronic stress as measured by hair cortisol(Baseline, 4-5 months post-baseline, 12 months post-baseline, 24 months post-baseline)
- Change in psychological violence as measured by Index of Psychological Abuse(Baseline, 4-5 months post-baseline, 12 months post-baseline, 24 months post-baseline)
- Change in child abuse as measured by the Youth Victimization Scale(Baseline, 4-5 months post-baseline, 12 months post-baseline, 24 months post-baseline)
- Change in belief about gender norms as measured by the Gender Equitable Mens Scale (GEMS)(Baseline, 4-5 months post-baseline, 12 months post-baseline, 24 months post-baseline)