A Mentalization-based Intervention to Enhance the Quality of Caregiver-child Interaction and Reduce the Risk of Child Maltreatment: a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Feasibility of Conducting a Full-Scale Trial: Recruitment, Retention, and Protocol Acceptability Assessed Through Semi-Structured Interviews and Attendance Records
研究概览
简要总结
The goal of this feasibility randomized controlled trial is to evaluate the effectiveness and acceptability of the Lighthouse Mentalization-Based Treatment Parenting Program (Lighthouse MBT-P) as an intervention for parents at risk of maltreating their children. The study focuses on parents with a history of childhood trauma, aiming to improve parent-child relationships, reduce parenting stress, and ultimately decrease the risk of child maltreatment.
The goal of this study is to test how well the Lighthouse Mentalization-Based Treatment Parenting Program (Lighthouse MBT-P) works for parents who may be at risk of harming their children. The program aims to help parents understand and manage their own and their children's emotions better. By improving these skills, the program hopes to reduce stress in parenting and lower the chances of child abuse or neglect.
The main questions this study will answer are:
- Can parents follow and complete the Lighthouse MBT-P program?
- Does the program help lower stress in parenting and improve relationships between parents and their children?
Participants in this study will:
- Attend weekly group sessions for 12 weeks. These sessions will teach them how to better understand and manage emotions.
- Take part in discussions led by trained psychologists.
Researchers will compare the results of parents who take part in the Lighthouse MBT-P program with those who receive standard parenting support to see which approach works better.
详细描述
This study is a feasibility randomized controlled trial designed to assess the Lighthouse Mentalization-Based Treatment Parenting Program (Lighthouse MBT-P) for parents who are at risk of maltreating their children. The Lighthouse MBT-P program is specifically tailored for parents with a history of trauma and aims to enhance their mentalizing abilities-helping them better understand and reflect on their own and their children's emotions and thoughts. By improving these skills, the program intends to strengthen parent-child relationships, reduce parenting stress, and ultimately decrease the risk of child maltreatment.
Study Design:
The study is being conducted at Diego Portales University in Santiago, Chile, with a total of 60 participants who will be randomly assigned to one of two groups: the intervention group receiving the Lighthouse MBT-P program and a control group receiving standard psychoeducational support. The intervention will consist of weekly 2-hour group sessions over 12 weeks, where participants will engage in psychoeducation and reflective discussions, facilitated by trained psychologists. These sessions aim to provide parents with the tools to improve their emotional regulation, understand their children's needs better, and develop healthier parenting practices.
Study Phases:
Cultural Adaptation: The Lighthouse MBT-P program has been culturally adapted to ensure its relevance and effectiveness within the Chilean context. This phase involved consultations with local experts, community stakeholders, and pilot testing with a small group of parents to refine the intervention content and delivery methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
In this study, both the participants and the outcomes assessors are blinded to the treatment assignments. Participants are unaware of which one of the interventions are receiving. The outcomes assessors, who are responsible for evaluating the results of the intervention, do not have access to information about which intervention each participant received, ensuring that their assessments are unbiased.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biological parents of children (0-36 months old) with custody of their child.
- •Parents who have gone through adverse childhood experiences, have a history of parental substance abuse or incarceration, have current exposure to relationship violence, or social isolation, or have lost custody of a child in the past.
- •Parents must be over the age of 18.
排除标准
- •Parents who are unable to provide informed consent due to mental or cognitive impairment,
- •Parents not fluent in Spanish.
- •Child's diagnosis of autistic spectrum disorder or severe cognitive delay.
结局指标
主要结局
Feasibility of Conducting a Full-Scale Trial: Recruitment, Retention, and Protocol Acceptability Assessed Through Semi-Structured Interviews and Attendance Records
时间窗: Measured continuously from the start of recruitment through the end of the intervention period (12 weeks for control group, 26 weeks for intervention group).
The feasibility of conducting a future full-scale trial will be assessed through the following measures: Participant Acceptability: Assessed via semi-structured interviews to capture participants' understanding, views, and experiences, including potential barriers or facilitators. Clinician Acceptability: Evaluated through in-depth interviews with clinicians, focusing on barriers, facilitators, and perceptions of the intervention. Adherence: Monitored through attendance records, with successful adherence defined as at least 65% of participants attending 40% or more of sessions. Recruitment and Retention: Recruitment tracked by the percentage of invited participants who consent to participate, with retention determined by the attrition rate, targeting no more than 20%.
次要结局
- Change in Parenting Stress from Baseline to 6-Month Follow-Up Using the Parenting Stress Index-Short Form (PSI-SF)(Measured at three specific points: baseline (pre-intervention), end of treatment (12 weeks for control group/26 weeks for intervention group), and 6-month follow-up.)
- Change in Quality of Life in Parents from Baseline to 6-Month Follow-Up Using the SF-36 Health Survey(Measured at three specific points: baseline (pre-intervention), end of treatment (12 weeks for control group/26 weeks for intervention group), and 6-month follow-up.)
研究者
Stefanella Costa Cordella
Professor
University Diego Portales