Resilient Students Training (ReST): A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Resilience
研究概览
简要总结
Resilience is the ability to survive and thrive despite significant adversity. Trials of resilience-promoting interventions for university students have shown significant improvements in students' resilience and reductions in depressive and stress symptoms. Therefore, the goal of this study is to examine the feasibility of Resilient Student Training Intervention (ReST) to enhance resilience and reduce symptoms of depression, anxiety, and stress in university students with at least one adverse childhood experience (ACE) in Hong Kong.
The study will be conducted in two phases. Phase 1 is a co-designing approach with local university students to discover, define, develop, and deliver the ReST intervention based on the Double Diamond model (Design Council, 2015). In Phase 2, eligible participants will be randomly allocated to either receive the ReST intervention or a waitlist control group. In the intervention group, participants will receive one 60-minute individual session and two 90-minute group-based sessions.
Our main objectives in this study are to answer the following research questions:
- Can an effective Resilience Student Training Intervention (ReST) be used to improve resilience among undergraduate students with adverse childhood experiences and mental distress?
- What proportion of eligible individuals participate, engage, and complete the interventions as part of the trial?
- What proportion of eligible individuals participate in, engage with, and complete research assessments, and what data quality and completion rates can therefore be obtained?
- Is the ReST intervention safe and acceptable from the participants' perspectives?
- What sample size is required for a definitive trial?
详细描述
INTRODUCTION
The occurrence of childhood adversities is more common than previously thought. A recent survey showed that 62% of Hong Kong adults have at least one adverse childhood experience (ACE; a serious, potentially traumatic, and life-altering stressor that occurs before age 18), and nearly 40% have 2 or more ACEs. Resilience was not only protective of mental health but a stronger predictor of mental health status than their ACE history. Existing resilience-promoting interventions for university students have shown improvements in their well-being, but only with small effect sizes and overall low quality of evidence; most trials also involve well-functioning students with unknown trauma histories. Further, existing interventions include a broad spectrum of intervention strategies informed by a wide range of individual and systemic resilience-promoting factors, but all interventions tested to date used a one-size-fits-all approach to improve student resilience without addressing underlying differences in how the resilience process manifests for different individuals. In response, the Youth Resilience Process Model was developed to explain divergent pathways in the youth resilience process based on typologies of initial response to adversity. The model is used to underpin the design of the ReST intervention in this study. In the present study, a Resilient Student Training intervention (ReST) will be co-designed with university students and evaluate the feasibility of a full-scale randomized controlled trial of the intervention. This involves preliminary testing of whether the intervention results in improvements in resilience.
AIMS AND OBJECTIVES
This study aims to (1) Co-design and develop a Resilient Student Training intervention (ReST) so that it can be used with undergraduate students, (2) Test feasibility, acceptability, and safety of the ReST intervention in students with low resilience, adverse childhood experiences, and moderate to severe levels of mental distress, (3) Assess recruitment/retention rates, data quality, and trial procedures for a definitive RCT, and (4) Explore student participants' experiences of taking part in the trial and the intervention to inform subsequent modifications to the intervention and trial design.
METHOD
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
- None
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Current PolyU undergraduate student;
- •Low resilience (based on the BRS score between 1.00-2.99);
- •Moderate to severe depression, anxiety, or stress (based on the DASS-21 cut-offs); and
- •Self-report of at least one ACE (based on the WHO ACE-IQ).
排除标准
- •Diagnosis of any mental illnesses;
- •Developmental disability;
- •Extremely severe levels of depression, anxiety, or stress (based on DASS-21 cut-offs); and
- •Receiving any mental health or psychiatric service or resilience-promoting interventions currently or within the past 6 months.
结局指标
主要结局
Resilience
时间窗: Week 0 (baseline), Week 6 (post-intervention), and Week 10 (follow-up).
The Brief Resilience Scale (BRS), a 6-item self-report questionnaire that measures perceived ability to bounce back from adversity will be used. Responses are provided on a 5-point Likert scale ranging from "strongly disagree=1" to "strongly agree=5." Scores are calculated based on the average of the 6 items, with cut-offs defined as low resilience (1-2.99), normal (3-4.30), and high (4.31-5.0). The Chinese BRS demonstrated good internal consistency, criterion validity, and construct validity when applied in university undergraduate students (Fung, 2020).
Feasibility of the intervention
时间窗: Week 0 (baseline), Week 6 (post-intervention), and Week 10 (follow-up).
Proportion of eligible individuals who consent, participate, and complete the intervention/ research assessments.
Acceptability of the intervention
时间窗: Week 6 (post-intervention) and Week 10 (follow-up).
Quantitative measure of participant satisfaction based on a 5-point Likert scale ranging from "1=Very Dissatisfied" to "5=Very Satisfied," and qualitative description of participants' perspectives on acceptability of the intervention.
Safety of the intervention based on number of adverse events
时间窗: Week 0 (baseline), Week 6 (post-intervention), and Week 10 (follow-up).
Number and type of adverse events will be recorded.
次要结局
- Depression(Week 0 (baseline), Week 6 (post-intervention), and Week 10 (follow-up).)
- Stress(Week 0 (baseline), Week 6 (post-intervention), and Week 10 (follow-up).)
- Anxiety(Week 0 (baseline), Week 6 (post-intervention), and Week 10 (follow-up).)
- Posttraumatic Stress(Week 0 (baseline), Week 6 (post-intervention), and Week 10 (follow-up).)
研究者
HO Wing Ka Grace
Associate Professor
The Hong Kong Polytechnic University