The STIME Project: Intersectoral Prevention of Severe Youth Mental Health Difficulties
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Well-being
研究概览
简要总结
This randomized controlled trial aims to evaluate the effectiveness of participation in five different STIME (Strengthened Cross-Sectoral Initiative for Children and Young People's Mental Health) interventions: 'Signs of Disordered Eating', 'Signs of Internalizing', 'Signs of Self-Harm', 'Take the Control Back', and 'The Parent Pilots'. The hypothesis is that participation in one of these interventions will be more effective than Management As Usual (MAU). Each intervention consists of three core components: early identification and screening, therapy based on evidence-informed manuals, and support within the child's learning environment.
详细描述
This project consists of five separate randomized controlled trials, each designed to evaluate the effectiveness of one of the five STIME interventions.
Mental health difficulties in childhood can have wide-ranging negative consequences for a child's development, learning, education, physical and psychological health in adulthood, family formation, and later attachment to the labor market. Thus, mental health difficulties among children and adolescents constitute a significant public health issue that requires immediate cross-sectoral action.
Existing research points to effective strategies for the prevention of progression of mental health difficulties to mental health problems that require psychiatric treatment. However, we still know relatively little about whether and how interventions work in the real-life contexts in which they are intended to function. In particular, there is a lack of research on implementation in practice-an evidence gap that may be bridged by integrating systematic evaluation components into existing prevention programs such as STIME.
STIME is a collaboration between municipalities and the regional child and adolescent psychiatry, aiming to prevent the progression of mental health difficulties among children and adolescents aged 3-17 years, before specialized treatment is required. The interventions target a subclinical population-that is, children and adolescents who show signs of mental health difficulties, such as anxiety, disordered eating, or self-harm, but who do not meet the diagnostic criterias for a mental disorder. As part of the collaboration, regional mental health services are responsible for training municipal psychologists, while the municipalities are in charge of delivering the interventions.
Although a pilot evaluation indicates that the STIME interventions are promising, there is a need for a rigorous examination of their effectiveness. The present study will therefore investigate the effectiveness of five STIME interventions.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Each of the interventions has elaborate and narrowly defined inclusion and
排除标准
- •. These are listed below for each intervention.
- •'Signs of Internalizing'
- •Inclusion criteria
- •Adolescents aged 12-17 years
- •Mild to moderate impairment in daily functioning (e.g., reduced engagement in school, social life, or leisure activities compared to before symptoms)
- •Adolescents with well-managed ADHD or autism may be included if they demonstrate sufficient mentalizing abilities and can benefit from the intervention with parental support
- •Presence of both anxiety and depressive symptoms, neither of which dominates or meets full diagnostic criteria
- •The family is motivated to participate
- •Exclusion criteria
- •Symptoms of moderate to severe depression
- •Presence of OCD, PTSD, agoraphobia, panic disorder, or other psychiatric conditions
- •Low cognitive functioning
- •Moderate to severe functional impairment (e.g., school dropout, extreme social withdrawal, daily reliance on adult support, lack of motivation for treatment)
- •Recent unsuccessful psychological treatment
- •Primary problems related to family dynamics or a highly burdened family situation
- •Increased or acute suicide risk
- •Presence of self-harm or symptoms of disordered eating
- •'Signs of Disordered Eating'
- •Inclusion criteria
- •Children and adolescents aged 10-17 years
- •High body dissatisfaction, preoccupation with food and/or body image, and/or early behavioral signs of an eating disorder
- •Stable physical condition, manageable in consultation with the adolescent's general practitioner
- •Able to consume food with guidance and support
- •The family is motivated to participate
- •Exclusion criteria
- •Previous treatment for an eating disorder
- •Symptoms meeting criteria for specialized psychiatric treatment
- •Low cognitive functioning
- •Significant weight loss
- •Solely restrictive or selective eating without other eating disorder symptoms
- •Severe comorbidity
- •Increased or acute suicide risk
- •Eating difficulties solely related to lifestyle factors
- •'Signs of Self-Harm'
- •Inclusion criteria
- •Adolescents aged 12-17 years
- •Current thoughts of self-harm
- •At least one episode of direct (non-suicidal) self-harm within the past three months
- •The family is motivated to participate
- •Exclusion criteria
- •Increased suicide risk
- •Psychiatric disorder requiring further assessment or not adequately treated
- •Low cognitive functioning
- •Self-harm only in socially accepted contexts (e.g., piercings or tattoos)
- •Only indirect self-harm (e.g., excessive substance use)
- •Only self-harm by proxy (involving another person)
- •'Take the Control Back'
- •Inclusion criteria
- •Children and adolescents aged 5-17 years
- •Experiencing obsessive thoughts and/or compulsive behaviors of mild to moderate severity
- 另有 22 项未显示
研究组 & 干预措施
Intervention group
干预措施: 'the Parent Pilots' (Behavioral)
Intervention group
干预措施: 'Take the Control Back' (Behavioral)
Intervention group
干预措施: 'Signs of Disordered Eating' (Behavioral)
Intervention group
干预措施: 'Signs of Self-Harm' (Behavioral)
Intervention group
干预措施: 'Signs of Internalizing' (Behavioral)
Control group
干预措施: Active comparator ('Signs of Disordered Eating', 'Signs of Internalizing', 'Signs of Self-harm' and 'Take the Control Back') (Behavioral)
Passive Control ('the Parent Pilots')
For the STIME intervention, 'the Parent Pilots', half of the families will be randomly assigned to the control group and will be enrolled in the intervention after 10 weeks.
结局指标
主要结局
Well-being
时间窗: For intervention group: From enrollment (T0) to the end of treatment (10 weeks) (T1) and 6 months post T0. For control group: From enrollment (T0) to 10 weeks (T1).
WHO-5 Well-being Index (Topp et al., 2015). The World Health Organization Five Well-Being Index, minimum score of 0 and maximum score 25, where higher scores indicate better mental well-being.
次要结局
- Disordered Eating(For intervention group: From enrollment (T0) to the end of treatment (10 weeks) (T1) and 6 months post T0. For control group: From enrollment (T0) to 10 weeks (T1).)
- Emotional dysregulation(For intervention group: From enrollment (T0) to the end of treatment (10 weeks) (T1) and 6 months post T0. For control group: From enrollment (T0) to 10 weeks (T1).)
- Anxiety and depression(For intervention group: From enrollment (T0) to the end of treatment (10 weeks) (T1) and 6 months post T0. For control group: From enrollment (T0) to 10 weeks (T1).)
- Impulsivity, hyperactivity, and inattention difficulties(For intervention group: From enrollment (T0) to the end of treatment (10 weeks) (T1) and 6 months post T0. For control group: From enrollment (T0) to 10 weeks (T1).)
- Obsessive thoughts and compulsive behaviors(For intervention group: From enrollment (T0) to the end of treatment (10 weeks) (T1) and 6 months post T0. For control group: From enrollment (T0) to 10 weeks (T1).)
- Well-being SDQ(For intervention group: From enrollment (T0) to the end of treatment (10 weeks) (T1) and 6 months post T0. For control group: From enrollment (T0) to 10 weeks (T1).)