Clinical trial NCT06238869: Online Mental Health Interventions for Children and Adolescents (OMHICA)
Official title: Multi-faceted Online Interventions to Promoting Mental Health in Children and Adolescents:a Population-based, Cluster-randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Depression
Anxiety
Stress
Insomnia
Keywords: Computerized Cognitive Behavioral Therapy
Music Therapy
Health education
Acoustic features
Lead sponsor: Jiangsu Province Nanjing Brain Hospital
Sponsor class: OTHER
First posted: 2024-02-02
Enrollment: 7000
Sex: ALL
Minimum age (years): 11
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Willing elementary students, with parental consent, to undergo mental health screenings and engage in subsequent mental health activities.
* Ages between 11 and 19.
* Participants who can operate a mobile phone and can read and receive messages on "WeChat".

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change from baseline in DASS-depression detection rate
timeFrame: Baseline, week 4 and week 28
measure: Change from baseline in DASS-anxiety detection rate
timeFrame: Baseline, week 4 and week 28
measure: Change from baseline in DASS-stress detection rate
timeFrame: Baseline, week 4 and week 28
measure: Change from baseline in Insomnia Severity Index (ISI) questionnaire insomnia detection rate
timeFrame: Baseline, week 4 and week 28
Secondary outcomes:
measure: Change from baseline in depressive symptom assessed by The Depression Anxiety Stress Scale (DASS) at week 4, week 8, and week 28.
timeFrame: Baseline, week 4 and week 28
measure: 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.
timeFrame: Baseline, week 4 and week 28
measure: Change from baseline in stress symptom assessed by The Depression Anxiety Stress Scale (DASS) at week 4, week 8, and week 28.
timeFrame: Baseline, week 4 and week 28
measure: Change from baseline in insomnia symptoms assessed by the Insomnia Severity Index (ISI; range: 0-28) at week 4, week 8, and week 28.
timeFrame: Baseline, week 4 and week 28
measure: Change from baseline in acoustic features.
timeFrame: Baseline, week 4 and week 28
measure: Change from baseline in the facial expression features measured.
timeFrame: Baseline and week 28
measure: Change from baseline in the Strengths and Difficulties Situation assessed by Strengths and Difficulties Questionnaire (SDQ).
timeFrame: Baseline and week 28
measure: Change from baseline in resting-state magnetic resonance imaging (MRI), diffusion tensor imaging (DTI) and structural (T1-weighted) imaging at baseline and week 4
timeFrame: Baseline and week 4
measure: 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.
timeFrame: Baseline and week 28
measure: The change from baseline in internet addiction symptom was assessed by the Internet Addiction Scale at week 4 and week 28.
timeFrame: Baseline and week 28
measure: The change from baseline in the implementation of NSSI behaviors was assessed by Ottawa Self-injury Inventory (OSI) at week 4 and week 28.
timeFrame: Baseline and week 28
measure: 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.
timeFrame: Baseline and week 28
measure: 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.
timeFrame: Baseline and week 28
measure: The change from baseline in food addiction symptom was assessed by Modified Yale Food Addiction Scale (mYFAS) at week 4 and week 28.
timeFrame: Baseline and week 28
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Affiliated Brain Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: Nanjing Brain Hospital, Nanjing Medical University
name: Fei Wang, Ph.D
role: STUDY_CHAIR
References: