Implementation of an E-version of the Skills Training START NOW for Promoting Emotion Regulation and Resilience in Residential Youth Care and Correctional Institutions: a Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Response to web-based training: pre-post participation CHANGE in psychological inflexibility as measured by scores on the AFQ-Y questionnaire
研究概览
简要总结
Almost every young person has experienced difficult situations, crises and stress in his or her life. It is difficult to cope with such situations and it is not uncommon for mental health to be affected. At the same time, those affected often do not get any help. There are too few offers of help. That is why the investigators have developed the START NOW training and the corresponding WebAPP. With this training, young people can train their resilience, i.e. their psychological resistance. Resilient people cope better with difficult situations and remain psychologically healthy for longer. Because the START NOW training is now also available as a WebAPP, users can apply it practically, playfully and at any time. Furthermore, the WebAPP can be used as a prevention and treatment option in a resource-saving and cost-efficient way in institutions. The aim is to find out in a randomized study design with two treatment conditions and a waiting group whether START NOW is effective as a newly developed WebAPP. Specifically, the investigators will investigate whether a digital web-based self-help training can already achieve positive effects or whether a format in which accompanying guidance by a coach and social learning is possible (support by a trainer who guides young people during the training) is better for achieving sustainable changes.The project is funded by the Federal Office of Justice as part of a pilot project.
详细描述
Psychological Flexibility (PF) is associated with improved mental health across a multitude of contexts and populations, while psychological inflexibility is associated with mental health problems, in particular depression and anxiety. Taking into consideration that prevalence rates of clinically significant anxiety and depression in large youth cohorts are high and even increased especially due to Covid-19, interventions aiming to enhance psychological flexibility are of particular importance. START NOW represents one approach that is well equipped to promote PF. It is an evidence-based, integrative skills training program, which offers a broad scope of applicability to different populations and contexts by promoting general psychological health and resilience.
Web-based health approaches are well established across settings, populations and a range of mental health outcomes and offer benefits such as cost-effectiveness, high accessibility and flexibility, direct and convenient use of resources, anonymity, decreased stigmatization and a feasible way to ensure continuity of care in transitional phases. Our project aims to develop and evaluate a web-based translation of the existing START NOW skills training that promotes PF in institutionalized youth.
The investigatorss will investigate the efficacy of web-based START NOW on PF in a randomized controlled trial comparing the following conditions: 1) Web-based group training guided by a trained START NOW facilitator (either face-to-face or through videoconferencing) 2) Web-based self-help without guidance 3) Treatment as usual (TAU)
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
盲法说明
open
入排标准
- 年龄范围
- 14 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Youth and young adults in Residential Youth Care (RYC) or Correctional Institutions (CI)
- •Age between 14-24 at time of screening
- •Need for improvement: Avoidance and Fusion Questionnaire for Youth (AFQ-Y) equal or higher than 34.05, or
- •Massachusetts Youth Screening Instrument-2 (MAYSI-2) subscale Angry-Irritable equal or higher than 5, or
- •MAYSI-2 subscale Depressed-Anxious equal or higher than
- •Sufficient speaking, writing and reading skills in German or French
- •(Written) informed consent
- •No planned discharge before end of intervention phase; Exception: Self-Help condition
排除标准
- •Suicidality: MAYSI-2 subscale Suicide Ideation equal or higher than 2
- •Acute psychotic symptoms or mania: MAYSI-2 subscale Thought Disturbance equal or higher than 1
- •Concurrent Cognitive Behavioral Therapy (CBT) based skills training similar to START NOW
结局指标
主要结局
Response to web-based training: pre-post participation CHANGE in psychological inflexibility as measured by scores on the AFQ-Y questionnaire
时间窗: Primary endpoint is the CHANGE in total score between baseline (T1) and follow-up (T3, 12 +/- 2 weeks after the end of the intervention)
The AFQ-Y is a widely used and validated self-rating questionnaire for assessing Psychological Flexibility in youth and young adults. Participants answer 17 items indicating how true each item is for them on a 5-point Likert scale (0 = not at all true; 4 = very true). Higher total scores indicate lower PF. Items are based on ACT models of human suffering representing the theoretical concept of psychological inflexibility due to high cognitive fusion and experiential avoidance. Data will be assessed within 2 weeks before start of skills training (baseline, T1), within 2 weeks after end of skills training (post-treatment assessment, T2), as well as at 12 weeks (+/- 2 weeks) (T3) and 24 weeks (+/- 2 weeks) (T4) post skills training. Primary endpoint is the change in total score between baseline (T1) and follow-up (T3). Total scores can range between 0 and 68. Accordingly, a change in score can range between -68 to +68.
次要结局
- change in resilience (all 3 conditions)(- between baseline (T1) and post-training (T2, ≤2 weeks after end of intervention ) - between baseline (T1) and 12-week follow-up (T3, after the end of intervention) - between baseline (T1) and 24-week follow-up (T4))
- change in self-reported self-efficacy (all 3 conditions)(- between baseline (T1) and post-training (T2, ≤2 weeks after end of intervention ) - between baseline (T1) and 12-week follow-up (T3, after the end of intervention) - between baseline (T1) and 24-week follow-up (T4))
- change in general impairment (all 3 conditions)(- between baseline (T1) and post-training (T2, ≤2 weeks after end of intervention ) - between baseline (T1) and 12-week follow-up (T3, after the end of intervention) - between baseline (T1) and 24-week follow-up (T4))
- change in depression and anxiety (all 3 conditions)(- between baseline (T1) and post-training (T2, ≤2 weeks after end of intervention ) - between baseline (T1) and 12-week follow-up (T3, after the end of intervention) - between baseline (T1) and 24-week follow-up (T4))
- change in self-reported psychological well-being (all 3 conditions)(- between baseline (T1) and post-training (T2, ≤2 weeks after end of intervention ) - between baseline (T1) and 12-week follow-up (T3, after the end of intervention) - between baseline (T1) and 24-week follow-up (T4))
- change in anger-irritability (all 3 conditions)(- between baseline (T1) and post-training (T2, ≤2 weeks after end of intervention ) - between baseline (T1) and 12-week follow-up (T3, after the end of intervention) - between baseline (T1) and 24-week follow-up (T4))
- change in substance use (all 3 conditions)(between screening (T0) and 12 week follow-up (T3, 12 weeks after the end of the intervention))
研究者
Prof. Christina Stadler
Principal Investigator, Professor for Developmental Psychopathology (Full professorship), Department of Child and Adolescent Psychiatry (UPK-KJ), Psychiatric University Clinics Basel (UPK)
University Psychiatric Clinics Basel