Empowering Youth in Care Against (re-)Victimization (Subproject 4): A Randomized Balanced Factorial Trial Examining an Internet-based Prevention Program for Primary Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 317
- 试验地点
- 4
- 主要终点
- Change in frequency of (re-)victimization
研究概览
简要总结
The primary aim of this study is to examine the effects of an internet-based prevention program for primary caregivers of preadolescent Youth in Care (Y-IC) on (re-)victimization. We aim to identify the most effective intervention components by using a randomized factorial design, based on the Multiphase Optimization Strategy (MOST; Collins, 2018). In a 2 x 2 x 2 x 2 factorial trial, an initial N = 317 foster caregivers with children ages 8 - 13 are randomly assigned to one of 16 conditions. The primary outcome is the rate of (re-)victimization from pre- to 3-month follow-up. Secondary outcomes include risk-taking and functional behaviors in relationships. All caregivers will receive access to all components after trial ends if there is no significant harm associated with any of the intervention component. Participants in the condition with all component levels on are expected to show the best improvement. Anticipated date for study completion is determined by the funding period. However, we plan to apply for a study extension.
详细描述
Given that childhood victimization leads to an increased vulnerability for subsequent revictimization in adolescence, findings highlight a strong need for evidence-based prevention programs targeting children with a history of child maltreatment as a high-risk population of revictimization. However, evidence-based programs for foster parents that aim to prevent revictimization of the child, while addressing the needs of the caregivers are scarce. In order to develop and tailor such services to foster parents (and youth in care) with maltreatment experiences, we developed a consumer-informed conceptual model in a prior project (EMPOWERYOU SP3) that outlines the key mediators which may impact upon the risk of revictimization and how we plan to address these with different intervention components. Thus, in subproject 3 the conceptual model and the online-intervention components were developed, involving the participants themselves as well as relevant stakeholders. The usability of the online-intervention and the feasibility of the clinical trial (EMPOWERYOU SP4) was piloted in subproject 3 (March 2021 - September 2021).
In subproject 4, we will conduct a factorial study to tear apart the main effects of each intervention component on the mediator and outcome of interest, including potential interaction effects. This will help optimizing the intervention approach. The full online-intervention comprises five content modules and a coach, who is supporting the caregiver with up to four phone-calls (50 minutes each) and short message service (SMS) or e-mail reminders. Caregivers have two weeks to work through one module. Every caregiver will receive the first two basic modules on parental self-care and child´s self-worth and emotional regulation. This allows us to offer some level of support in all conditions including the condition with the lowest component level across all factors.
Based on the MOST principles, this study will use a 2 x 2 x 2 x 2 full factorial design by randomly allocating families with equal probability to one of 16 experimental conditions. However, this factorial experiment does not represent a 16-arm randomized controlled trial (RCT). The ultimate goal is to choose from a set of four intervention components with two levels each (on/off) the one(s) that best reduce and prevent (re-)victimization. The following intervention components have been selected (three content components, one engagement/adherence component):
- Component: "Watch out!" (on/off): Improving relationship-related risk detection and self-protective behavior
- Component: "You are safe here" (on/off): Improving relationship-related safety and facilitating solid relationships
- Component: "Who am I and where do I belong?" (on/off): Supporting the child constructing an identity
- Component: "My Coach" (on/off): Professional support of the caregiver in form of up to four phone calls with a coach (i.e., one call per module 1&2 (combined), 3, 4, and 5).
The primary research objectives are:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Study staff at University of Bremen will not view the allocation sequence. The database will not reveal participants' treatment condition to study staff until after the family´s eligibility was verified (after pre-assessment). Families will be informed of their allocation status after baseline data collection is completed to assure that participants are blind to allocation during the initial assessment.
入排标准
- 年龄范围
- 8 Years 至 13 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary caregivers (foster or adoptive) of children aged 8 to 13 years old
排除标准
- •acute child endangerment
- •short-term foster families ("Bereitschaftspflege")
- •family care ("Verwandschaftspflege")
- •insufficient German language knowledge
结局指标
主要结局
Change in frequency of (re-)victimization
时间窗: Pre and 3 months post intervention; approx. 24 weeks after baseline
The (re-)victimization composite score derived from two parent-report measures: The Juvenile Victimization Questionnaire (JVQ) and the Bullying screener. The JVQ is a widely used measure to assess victimization in children aged 8 to 17 years. It consists of 37 items spanning five domains: crime, child maltreatment, peer and sibling victimization, sexual victimization and witnessing crime with follow-up questions that also assess the frequency and perpetrators of the victimization events. Caregivers will be asked whether the child was exposed to the respective event during life and (if yes) during the last 3 months. Participants respond with yes (1) or no (0). The Bullying screener is a 6-item screening tool. After the respective definition of bullying type, caregivers are asked how often these things happened to the child or how often he/she has done this to others in the last 3 months. Caregivers then respond on a 4-point scale from never to a lot (at least once a week).
次要结局
- Change in level of functional behavior across unspecified relationships(Pre and 1 week post intervention; approx. 12 weeks after baseline)
- Change in frequency of relationship-related risk-taking behavior(Pre and 1 week post intervention; approx. 12 weeks after baseline)
- Change in level of functional behavior in relationship with siblings(Pre and 1 week post intervention; approx. 12 weeks after baseline)
- Change in level of functional behavior in relationship with caregiver(Pre and 1 week post intervention; approx. 12 weeks after baseline)
