Multi-faceted Online Interventions to Promoting Mental Health in Children and Adolescents:a Population-based, Cluster-randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 7,000
- 试验地点
- 1
- 主要终点
- Change from baseline in DASS-depression detection rate
研究概览
简要总结
Mental health has become an increasing concern, especially among children and adolescents in schools. However, not all individuals in mental suboptimal states require pharmacological treatment. With the development of internet technology, internet-based psychological therapy methods are considered to have tremendous potential and are being given significant attention. Simultaneously, due to their convenience, these approaches are widely applied. Computerized Cognitive Behavioral Therapy (CCBT) can achieve its therapeutic effect by improving activation patterns of the brain's internal networks to promote self-regulation. Music Therapy (MT) can make peoples gradually relax via relaxing and soothing music, and regulate individual psychological emotions through the influence of music on individuals' cerebral cortex, hypothalamus and limbic system, further improve the mood of daily tension and anxiety. Health Education works to provide parents with knowledge and information about mental health, aiming to help them better understand and support their own and their children's mental health, thereby improving parent-child relationships.
The study was designed as a randomized clinical trial with four groups, the CCBT group, the MT group, the Health Education group and the control group in children and adolescent .The CCBT group, the MT group, and the Health Education group all completed their interventions through online self-help therapy. The control group did not receive any intervention. Data collection was conducted by trained, certified and qualified personnel.
The mental health intervention is a crucial component of the "School-based Evaluation Advancing Response for Child Health (SEARCH)" cohort study, focusing on observing changes in the population undergoing the intervention within the cohort study.
详细描述
The online intervention study was a population-based, cluster-randomized controlled trial that aimed to evaluate the efficacy of various interventions promoting mental health in children and adolescent.
The CCBT intervention consisted of two components: (a) The participants were presented with 12 modules. All modules were based on the cognitive- behavioral model by Beck and informed by the updated procedures by J. Beck and Wright. Modules 1-2 introduce the definitions, symptoms, causes and basic cognitive models of depression and anxiety. Modules 3-6 describe how to identify cognitive distortions and deal with negative automatic thoughts in daily life. Modules 7-8 mainly focus on behavioral activation and dealing with intermediate beliefs. Modules 9-11 center on learning about structured problem-solving approaches and core beliefs. Module 12 describes a summary of treatment and relapse prevention. (b) After each module is completed, we send a notification of homework to the subjects, and their compliance is assessed by registering completed modules and homework. The experimental group received a 4-week CCBT intervention, which consisted of completing 3 modules every week, each taking roughly 20 minutes.
All the participants of Music Therapy will be treated with 12 sessions (3 sessions per week),15 minutes each time, and conducted for 4 weeks. The MT is mainly divided into three stages, and each stage has a topic. The topic of each stage as follow: physical and mental relaxation stage: learning the whole body and mind relaxation mode from breathing to muscle; nature imagination stage: guiding music imagination; internal self-exploration: excavating the positive experience and positive potential of the listener and adopting resource orientation for psychological intervention.
The health education group will conduct a series of mental health lectures through the WeChat Mini Program on a weekly basis, with each session lasting for 30 minutes, spanning over a duration of four weeks. The themes of mental health lectures were:1.Parents communicate well with their children, and they thrive in the sun;2.Three effective increments in the growth of adolescents;3.early identification and intervention of adolescent emotional disorders;4.brain and emotions. While the control group did not receive any intervention during the same time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 11 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing elementary students, with parental consent, to undergo mental health screenings and engage in subsequent mental health activities.
- •Ages between 11 and
- •Participants who can operate a mobile phone and can read and receive messages on "WeChat".
排除标准
- •Participants with self-reported lifetime suicide attempts, active self-harm, or active suicidal ideation with intent will be excluded from the study.
- •Have a diagnosis by a clinician of bipolar disorder, substance use disorder, or any psychotic disorder including schizophrenia
- •Individuals who are incapable of understanding or completing study procedures and digital intervention, as determined by the participant, patient/legal guardian, healthcare provider, or clinical research team, will be excluded.
研究组 & 干预措施
Computerized Cognitive Behavioral Therapy (CCBT)
The experimental group received a 4-week CCBT intervention, which consisted of completing 3 modules every week, each taking roughly 20 minutes.
干预措施: Computerized Cognitive Behavioral Therapy (Behavioral)
Music Therapy(MT)
All the participants of Music Therapy will be treated with 12 sessions (3 sessions per week),15 minutes each time, and conducted for 4 weeks.
干预措施: Music Therapy (Behavioral)
Health education
The health education group will conduct a series of mental health lectures through the WeChat Mini Program on a weekly basis, with each session lasting for 30 minutes, spanning over a duration of four weeks.
干预措施: Health education (Behavioral)
Blank Control Group
All the participants in this group receive no intervention and undergo only psychological health screenings at designated time points.
结局指标
主要结局
Change from baseline in DASS-depression detection rate
时间窗: Baseline, week 4 and week 28
Change from baseline in the screening rate of depressive symptoms assessed by The Depression Anxiety Stress Scale within the population.
Change from baseline in DASS-anxiety detection rate
时间窗: Baseline, week 4 and week 28
Change from baseline in the screening rate of anxiety symptoms assessed by The Depression Anxiety Stress Scale within the population.
Change from baseline in DASS-stress detection rate
时间窗: Baseline, week 4 and week 28
Change from baseline in the screening rate of stress symptoms assessed by The Depression Anxiety Stress Scale within the population.
Change from baseline in Insomnia Severity Index (ISI) questionnaire insomnia detection rate
时间窗: Baseline, week 4 and week 28
Insomnia Severity Index (ISI) questionnaire insomnia detection rate refers to the rate at which insomnia is identified or detected based on responses from the ISI questionnaire. The ISI is a validated tool used to assess insomnia symptom severity and their impact on daily functioning. The detection rate indicates the proportion of individuals in a population or sample whose ISI questionnaire responses indicate the presence of insomnia.
次要结局
- Change from baseline in anxiety symptom assessed by The Depression, Anxiety and Stress Scale (DASS)at week 4, week 8, and week 28. Stress Scale (DASS) at week 4, week 8, and week 28.(Baseline, week 4 and week 28)
- Change from baseline in the facial expression features measured.(Baseline and week 28)
- Change in the influence of the family environment on the individual, as assessed by the Family Environment Scale (FES), from baseline to week 4 and week 28.(Baseline and week 28)
- The change from baseline in childhood traumatic experiences was assessed by Childhood Trauma Questionnaire-28 item Short Form(CTQ-SF) at week 4 and week 28.(Baseline and week 28)
- The change from baseline in internet addiction symptom was assessed by the Internet Addiction Scale at week 4 and week 28.(Baseline and week 28)
- Change from baseline in acoustic features.(Baseline, week 4 and week 28)
- Change from baseline in stress symptom assessed by The Depression Anxiety Stress Scale (DASS) at week 4, week 8, and week 28.(Baseline, week 4 and week 28)
- Change from baseline in insomnia symptoms assessed by the Insomnia Severity Index (ISI; range: 0-28) at week 4, week 8, and week 28.(Baseline, week 4 and week 28)
- Change from baseline in resting-state magnetic resonance imaging (MRI), diffusion tensor imaging (DTI) and structural (T1-weighted) imaging at baseline and week 4(Baseline and week 4)
- The change from baseline in the implementation of NSSI behaviors was assessed by Ottawa Self-injury Inventory (OSI) at week 4 and week 28.(Baseline and week 28)
- Change from baseline in depressive symptom assessed by The Depression Anxiety Stress Scale (DASS) at week 4, week 8, and week 28.(Baseline, week 4 and week 28)
- Change from baseline in the Strengths and Difficulties Situation assessed by Strengths and Difficulties Questionnaire (SDQ).(Baseline and week 28)
- The change from baseline in the victimization of bullying since enrollment was assessed by Delaware Bullying Victimization Scale (DBVS) at week 4 and week 28.(Baseline and week 28)
- The change from baseline in food addiction symptom was assessed by Modified Yale Food Addiction Scale (mYFAS) at week 4 and week 28.(Baseline and week 28)