The STIME Project: Intersectoral Prevention of Severe Youth Mental Health Difficulties
报名条件(概要)
- 年龄:3 Years – 17 Years
- 性别:不限
- 健康志愿者:不接受
完整入排标准请以官方页面为准。
开展国家/地区
Denmark
药品与企业信息
A manual-based family intervention for children and adolescents (10-17 years) experiencing overwhelming thoughts about food and body image, without meeting criteria for a diagnosed eating disorder. The intervention spans 2-3 months and consists of 5-10 sessions. A STIME therapist from the child's local municipality conducts the sessions with either the parents alone (for children aged 10-12 years) or with the whole family (for children aged 13-17 years). The intervention is based on family-based therapy, emphasizing the parents' role in supporting their child's healthy development. The intervention focuses on presentation of difficulties and change, incorporating elements from Cognitive Behavioral Therapy (CBT), including externalization, validation, and skills training. Practical strategies are applied through homework assignments, goal setting, and self-monitoring.
A manual-based intervention targeting adolescents (12-17 years) with self-harming thoughts and behaviors not requiring specialized psychiatric care. The intervention involves 9 sessions delivered by a trained STIME therapist, with both joint and individual sessions involving the adolescent and parents. Based on CBT, it integrates methods from Acceptance and Commitment Therapy (ACT), Dialectical Behavior Therapy (DBT), and Emotion-Focused Therapy (EFT). Focus areas include developing an understanding of the function and consequences of self-harm, as well as the role and impact of emotions in behavior.
A manual-based CBT intervention targeting adolescents (aged 12-17 years) with emotional difficulties consistent with anxiety and subclinical to mild depression, but not requiring treatment in specialized psychiatric care. The intervention begins with an assessment session and includes up to 14 sessions across 9 modules (6 core, 3 optional). Based on CBT, the intervention seeks to enhance the adolescent's understanding of how emotional experiences influence cognitive processes, physiological responses, and behavior. Methods include behavioral experiments, exposure, and emotion regulation strategies. The therapy is grounded in an individual case formulation, which identifies the maintaining factors of the young person's emotional difficulties and sets concrete goals for therapeutic work and change. Sessions involve the adolescent, parents, and relevant network members. Homework is assigned between sessions to support daily-life implementation.
A manual-based intervention for children and adolescents with subclinical signs of Attention Deficit Hyperactivity Disorder (ADHD). The intervention consists of four group sessions during 6-8 weeks, including parents/caregivers of up to eight children/adolescents, and is conducted by a STIME therapist from the child's local municipality. Individual sessions can be added when considered beneficial based on the family's needs. The intervention is based on family-based therapy and Vygotsky's Zone of Proximal Development and focuses on empowering parents to understand and address their child's behaviors. Between sessions, parents complete manual-structured homework and real-life practice at home. To reinforce progress and ensure consistency across the home and education settings, professionals from the child's educational setting or broader support network may also be involved
A manual-based intervention for children and adolescents (aged 5-17 years) with mild to moderate obsessive thoughts and compulsive behaviors, but not requiring treatment in specialized psychiatric care. The intervention begins with an assessment session and includes a minimum of eight sessions. Grounded in family-based cognitive behavioral therapy, it combines goal-focused work, psychoeducation, exposure, response, and prevention as the main therapeutic components. The primary aim is to support the child/adolescent in being exposed to situations that may trigger obsessive thoughts and to refrain from allowing these thoughts to dictate behavior. Sessions involve the child/adolescent and their parents. To support the process, it is possible to involve professionals from the learning environment and the child/adolescent's wider network. Homework assignments are given between sessions for both the child/adolescent and their parents, to support practice in daily life.
For the STIME-interventions 'Signs of Disordered Eating', 'Signs of Internalizing', 'Signs of Self-harm', and 'Take the control back', children and adolescents allocated to the control group will receive 3-4 individual online sessions with a psychologist over 10 weeks while waiting to start the intervention. The number of sessions depends on the presenting concern: up to three sessions for the interventions 'Signs of Internalizing', 'Signs of Self-harm', and 'Take the control back', and up to four sessions for the intervention 'Signs of Disordered Eating'. Sessions may involve the child/adolescent alone, the parents alone, or both together. Psychologists providing the sessions have experience working with all target groups, but have not received training in the STIME program. They will be given freedom to use less than the maximum number of sessions and to choose their therapeutic approach to mimic the variability of management as usual.
研发企业
试验官方登记的主要申办方;研究机构申办时会显示相应机构名称。
生产企业
公开药品批准资料或正式说明书暂未提供明确的生产企业信息。
研发企业与生产企业可能不是同一家。研究阶段药品可能尚未公布生产企业;生产企业仅取自美国上市原研药说明书所列企业(不含仿制药),不作推测;仅在其他国家上市的药品暂无法显示。
研究简介(原文)
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.
适应症
主动联系研究团队
这项试验目前在中国大陆没有研究中心
这种情况下,直接发"入组咨询"往往会被回复"您所在地区没有中心"。更有效的做法是申请同情用药/扩展准入(由主治医生一同提出),或询问能否到最近的境外中心参加。下面已为您切换到对应的信件版本。
查看完整申请路径与成功率说明 →总联系人(申办方/研究总部)
- Michaela Louise Schiøtz, PhD, cand.scient.san.publ.michaela.louise.schioetz@regionh.dk+4527333083
- Thea T Amholt, PhD, cand.psychthea.toft.amholt@regionh.dk
研究中心联系方式
- Center for Clinical Research and PreventionFrederiksberg,Denmark
问自己是否符合条件、如何预筛
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英文版(发给研究团队)
Dear Study Team, I am a patient in China and I am interested in participating in your clinical trial: Study Title: The STIME Project: Intersectoral Prevention of Severe Youth Mental Health Difficulties ClinicalTrials.gov Identifier: NCT07413887 Sponsor: Center for Clinical Research and Prevention Investigational product: 'Signs of Disordered Eating', 'Signs of Self-Harm', 'Signs of Internalizing', 'the Parent Pilots', 'Take the Control Back' About me: - Age: (please fill in) - Sex: (please fill in) - Confirmed diagnosis and stage: (please fill in) - Biomarkers / genetic testing: not available - Prior and current treatments: (please fill in) - Performance status (ECOG): not assessed - Current location: China - Travel ability: (please fill in) Could you please let me know: 1. Whether I might be eligible for this study; 2. Which site would be closest and most practical for me, and whether remote pre-screening is possible; 3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening. I can provide English translations of my medical records. Thank you very much for your time and help. Kind regards, (your name) (your email / phone with country code)
中文对照(供您核对)
尊敬的研究团队: 我是一位来自中国的患者,希望咨询参加以下临床试验的可能: 研究名称:The STIME Project: Intersectoral Prevention of Severe Youth Mental Health Difficulties 试验编号:NCT07413887 申办方:Center for Clinical Research and Prevention 研究药物:'Signs of Disordered Eating'、'Signs of Self-Harm'、'Signs of Internalizing'、'the Parent Pilots'、'Take the Control Back' 我的基本情况: - 年龄:(请填写) - 性别:(请填写) - 确诊疾病与分期:(请填写) - 基因/标志物检测:暂无 - 既往及当前治疗:(请填写) - 体能状态(ECOG):未评估 - 目前所在城市:中国 - 可前往范围:(请填写) 想请教三个问题: 1. 我是否可能符合本研究的入组标准? 2. 哪个中心对我最方便可行?能否远程预筛? 3. 预筛需要准备哪些资料(病历、病理、影像、近期化验)? 我可以提供英文翻译版病历。感谢您的时间与帮助。 顺祝安康 (您的姓名) (您的邮箱/带国际区号的电话)
提示:请与主治医生一起发信——由医生署名的申请,回复率远高于患者单独发信。首封邮件不要附身份证号等敏感信息。研究团队通常在 3–10 个工作日内回复,两周无回音可礼貌追问一次。
下一步怎么做?
- 把本页信息带给您的主治医生,评估是否适合参加。
- 点击下方按钮打开官方注册页,查看研究中心联系方式。
- 直接联系研究团队咨询报名事宜(通常有中文同声翻译服务可协助沟通)。