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临床试验/NCT02168985
NCT02168985Unknown不适用

Impact Evaluation for the Faithful House Program in Reducing Violence in Families in Which Couples Are Discordant or HIV/AIDS Positive in Arusha Region, in Tanzania

Savannas Forever Tanzania1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2014年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
300
试验地点
1
主要终点
Incidence of violence against or witnessed by children insults, and threats of physical harm and abandonment in the past three months and similar violent acts between partners that are observed by their children ages 10-17.

研究概览

简要总结

The Faithful House (TFH), is a 3-day faith-based skills-building curriculum which aims to increase household resilience by strengthening families. TFH draws on improved communication and conflict resolution skill building and the individual's faith-values as a catalyst for transformation in attitudes regarding gender roles in care giving and the use of violence in the home. The study hypothesis is that couples who complete the Faithful House Programme will demonstrate increased communication skills with their spouses and children, which reduces the negative impact of family stress triggers and ultimately leads to a reduction of intimate partner violence witnessed by children as well as physical and emotional violence against children by parents.

The mixed methods study will include a Randomized Control Trial (RCT) of HIV/AIDS infected or conflicted couples and a child in each household, focus group discussions (FGD) of men, women and children and key informant interviews of local experts in family violence and social protection service network providers.

详细描述

A mixed-method evaluation of The Faithful House is proposed. In the main, we will conduct a randomized control trial of the education program to determine treatment effect. We will also conduct semi-structured interviews and focus groups with stakeholders. This more qualitative work will be done in order to refine our program and evaluation and to assess the fidelity of the intervention and assess and unintended consequences. Informed consent will be sought from all prospective participants.

The source population is families that receive HIV care from Arusha Lutheran Medical Centre and Selian Hospital. Participation and related compliance is enhanced because subjects come to the hospital for HIV treatment. Couples with children ages 10 to 17 years will be recruited to participate in a Faithful House workshop and study by hospital volunteers. All patients attending the clinic during the recruiting period will be screened based on eligibility criteria. The list of patients screened will be checked against the clinic register to verify that all potential participants were screened and all eligible respondents were invited to participate in the workshop and study.

The list of recruited couples will be randomized to receive the intervention or to serve as the control arm. The control arm will be offered the intervention at the conclusion of the study. The goal is to have N=150 couples in the treatment arm and N=150 couples in the control arm. The rationale for the sample size is twofold. First, given the estimated variances from surveillance studies the sample size permits the estimates of small to moderate effect sizes at 80% power and 5% Type I error. In simple terms, the proposed evaluation is strongly powered to detect politically and clinically meaningful effects. Second, given time, budget, and patient flow characteristics, 300 couples is near the maximum of our capacity. Baseline measures will be taken via survey on all participants in a clinical setting about one month prior to beginning the education program. Post program measures will be taken in a clinical setting three months after the intervention is complete. A context-based pretest and post-test will be administered to only those in the treatment group on the first and last day of the intervention.

Gender and age specific surveys will be used to interview men, women and children and questions on self-reported violence will be included in women and children's questionnaires. Answers to questions on violence will be collected using non-verbal response cards to protect confidentiality and to assure respondents that enumerators will not know their responses.

Analyses will focus mainly on difference in estimates for the primary outcome measures of the self reported incidence by mothers and children (10-17) of acts of violence against women and children including child-witnessed violence in the past three months before the intervention and three months post intervention. Sub-group analysis by gender will be conducted. We will look at within group difference and between group differences. Retention will be assessed by comparing results from the pretest and post-test given on the first and last day of the intervention.

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

性别
All
接受健康志愿者
否

入选标准

  • •Both male and female partners in an HIV AIDS conflicted couple
  • •Has at least one child age 10 to 17 years living in couple's household

排除标准

  • 未提供

研究组 & 干预措施

Attend TFH Program

Experimental

Couples attend the three-day Faithful House Training program immediately

干预措施: TFH program (Behavioral)

Wait-listed for TFH Program

No Intervention

Couples attend The Faithful House program three-months after the initial group

结局指标

主要结局

Incidence of violence against or witnessed by children insults, and threats of physical harm and abandonment in the past three months and similar violent acts between partners that are observed by their children ages 10-17.

时间窗: Baseline and three months after couples attend seminar

Change in self-reported incidence by parents and children (10-17) of acts of physical and emotional violence against children such as kicking, hitting, verbal insults, and threats of physical harm and abandonment and similar violent acts between partners that are observed by their children ages 10-17 years at baseline and three-months after couples attend seminar.

次要结局

  • Attitudes about violence(Baseline and three months after seminar)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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