Stress, Emotional, Stress-related Mental Disorders
Conditions
Keywords
adolescents, randomized controlled trial, PTSD, depression, anxiety, stress-related mental disorders, rural area
Brief summary
This study aims to evaluate the effectiveness of school-based psychological interventions in improving stress resilience and coping skills among adolescents in rural China. The intervention seeks to reduce stress-related mental health symptoms, including depression, anxiety, and post-traumatic stress, measured using validated instruments such as the Patient Health Questionnaire-9 (PHQ-9), the Generalized Anxiety Disorder 7-item scale (GAD-7), and the Child PTSD Symptom Scale for DSM-5 (CPSS-5). (See Appendix for full scale descriptions.) Participants will be recruited from rural middle schools and randomly assigned to either an intervention group or a wait-list control group. The intervention consists of four sessions delivered over one week. Assessments will be conducted at baseline, immediately after the intervention, and again at a 3-month and 6-month follow-ups. Researchers will use multilevel modeling (MLM) and structural equation modeling (SEM) to examine potential mediators and moderators of intervention effects, including emotion recognition, alexithymia, and coping strategies. indings are expected to provide evidence on the effectiveness and mechanisms of an existing, school-based psychological intervention tailored to the needs of adolescents in underserved rural settings.
Interventions
Psychoeducation sessions for adolescents focus on essential topics like stress, emotional distress, and mental disorders, offering foundational knowledge to enhance their understanding and ability to manage these challenges effectively.
In the guided writing intervention, students are asked to write about a recent event that triggered strong emotions on paper and, based on the requirements of each session, attempt to regulate their emotions. This approach aims to enhance students' abilities in emotional identification and emotion regulation.
Participants will engage in their regular school activities, and after the intervention group completes the program, they will receive the same intervention content as the intervention group.
Sponsors
Study design
Eligibility
Inclusion criteria
* Currently enrolled middle school students attending regular school classes * Sufficient functional capacity in hearing, speaking, reading, and writing to participate in intervention activities and assessments.
Exclusion criteria
* Individuals assessed to be at high risk of suicide, based on screening or clinical judgment * Diagnosis of severe mental disorders (e.g., psychotic disorders, severe mood disorders) that would interfere with participation or require more intensive clinical care
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PTSD for adolescents | baseline, post treatment (2 weeks after baseline), 3 month after post treatment | The Child PTSD Symptom Scale for DSM-5 (CPSS-5) for adolescents and children (scores from 0 to 4, and total scores vary from 0 to 80). A higher score represents worse PTSD symptoms. |
| Depression | baseline, post treatment (2 weeks after baseline), 3 month after post treatment | The 9-item patient health questionnaire (PHQ-9) for adults (score ranges from 0 to 3, and the total score varies from 0 to 27). A higher score indicates worse depression symptoms. |
| Insomnia Severity | baseline, post treatment (2 weeks after baseline), 3 month after post treatment | The severity of insomnia symptoms will be assessed using the Insomnia Severity Index (ISI). This 7-item self-report measurement evaluates the severity of insomnia symptoms, the level of satisfaction with sleep, interference with daily functioning, noticeability of impairment attributed to sleep problems, and the level of distress caused by sleep disturbance (score from 0 to 4, and total score vary from 0 to 32). Each item is rated on a 5-point scale, providing a comprehensive measure of insomnia severity. |
| Generalized anxiety disorder | baseline, post treatment (2 weeks after baseline), 3 month after post treatment | The Generalized Anxiety Disorder-7 scale (GAD-7) for adults, adolescents, and children (scored from 0 to 3, and total score from 0 to 21). A higher score represents worse anxiety symptoms. |
| Alexithymia | baseline, post treatment (2 weeks after baseline), 3 month after post treatment | A 22-item Peking alexithymia scale measures thoughts and behaviors that prevent people from feeling or recognizing negative emotions on a 5-point Likert scale (1 to 5, and total scores vary from 22 to 110). A higher score represents more severe alexithymia. |
| Emotion awareness | baseline, post treatment (2 weeks after baseline), 3 month after post treatment | A 30-item Emotion awareness questionnaire measures emotion awareness on a 3-point Likert scale (1 to 3, with total scores ranging from 30 to 90). A higher score indicates better emotion awareness. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resilience | baseline, post treatment (2 weeks after baseline), 3 month after post treatment | The Connor-Davidson resilience scale is a 10-item resilience measurement scale that measures resilience on a 5-point Likert scale (scores range from 0 to 4, and the total score varies from 0 to 40). A higher score represents better resilience. |
| Game Addiction Scale | baseline, post treatment (2 weeks after baseline), 3 month after post treatment | A 7-item game addiction scale measures game addiction on a 5-point Likert scale (score from 1 to 5, and total score varies from 7 to 35), with higher scores indicating worse game addiction. |
| Self-esteem | baseline, post treatment (2 weeks after baseline), 3 month after post treatment | A 10-item self-esteem measurement scale, Rosenberg self-esteem scale, measures self-esteem on a 4-point Likert scale (score from 0 to 3, and total score varies from 0 to 30), with higher scores indicating greater self-esteem. |
| Subjective Happiness Scale | baseline, post treatment (2 weeks after baseline), 3 month after post treatment | A 4-item subjective happiness scale measures happiness (score from 1 to 7, and total score vary from 4 to 28). A higher score represents a happier state. |
| Frustration | baseline, post treatment (2 weeks after baseline), 3 month after post treatment | The 25-item frustration scale (score from 1 to 5, and total score varies from 24 to 120). A higher score represents less frustration. |
| Irritability | baseline, post treatment (2 weeks after baseline), 3 month after post treatment | A 17-item irritability measurement scale, the Peking irritability scale, measures impulsive emotions, thoughts, and behaviors on a 5-point Likert scale (score from 1 to 5, and total score varies from 17 to 85). A higher score represents higher irritability. |
| Cognitive emotion regulation | baseline, post treatment (2 weeks after baseline), 3 month after post treatment | An 18-item cognitive emotion regulation questionnaire measures the ability of emotion regulation on a 5-point Likert scale (1 to 5, and total scores vary from 18 to 90). A higher score represents more emotion regulation. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Behavior performances | baseline, post treatment (2 weeks after baseline), 3 month after post treatment | A 22-item behavior performance questionnaire measures various behavior performances such as study time, phone use, school performance, drinking alcohol, smoking, stealing, fighting, and lying. |
| Shame | baseline, post treatment (2 weeks after baseline), 3 month after post treatment | An 8-item shame scale measures shame (score from 0 to 4, and total score varies from 0 to 32). A higher score represents more shame. |
| Suicide | baseline, post treatment (2 weeks after baseline), 3 month after post treatment | The suicidal behaviors questionnaire-revised (SBQ-R) for adolescents and children (total scores vary from 3 to 18). A higher score represents a higher suicide risk. |
| Subjective Units of Distress Scale | During intervention (up to 4 days) | A single item inquires about subjective distress on a 100-point scale. A higher score represents more subjective distress. |
| Adverse Childhood Experiences | baseline, post treatment (2 weeks after baseline), 3 month after post treatment | A 33-item adverse events questionnaire asks about adverse events before 18, including self-harm, experiencing emotional abuse, experiencing physical abuse, feeling severe distress, mental illness events (e.g., panic attack), and physical injury, etc. The score of each item ranges from 0 to 1(0=no, 1=yes), 0 to 4, or 0 to 5 (a higher score indicates a more severe adverse event) |
| Meaning in life | baseline, post treatment (2 weeks after baseline), 3 month after post treatment | A 6-item meaning in life scale measures life meaning (score from 1 to 5, and total score varies from 6 to 30). A higher score represents a more life-meaning perception. |
| Non-suicidal self-injury | baseline, post treatment (2 weeks after baseline), 3 month after post treatment | The non-suicidal self-injury assessment tool (NSSI-AT-Severity) for adolescents and children (total scores vary from 5 to 16). A higher score represents a worse self-injury situation. |
| Somatic problems | baseline, post treatment (2 weeks after baseline), 3 month after post treatment | A somatic problems scale modified from PHQ-15, measuring various physical discomforts and pain on a 3-point Likert scale (score from 0 to 2). A higher score represents worse somatic problems. |
| EQ-5D-3L | baseline, post treatment (2 weeks after baseline), 3 month after post treatment | The EQ-5D-3L was developed by EuroQol to measure the health-related quality of life with 6 items. The 1\ 5 items are coded from 1 to 5, and the last item scores from 1 to 100. The scale will then be calculated into a value for further calculation of quality-adjusted life-years (QALYs), which will be used in the cost-effectiveness analysis. |
| Seeking for help | baseline, post treatment (2 weeks after baseline), 3 month after post treatment | A 10-item help-seeking scale measures on a 7-point Likert scale (score from 1 to 7, and total score varies from 10 to 70), with higher scores indicating greater willingness to seek help from others. |
| Positive Childhood Experiences | baseline, post treatment (2 weeks after baseline), 3 month after post treatment | A questionnaire measuring positive childhood experiences with 13 items(total scores vary from 0 to 64). A higher score represents a more positive childhood experience. |
| Social support | baseline, post treatment (2 weeks after baseline), 3 month after post treatment | The 12-item Multidimensional Scale of Perceived Social Support (score from 1 to 7, and total score varies from 12 to 84). A higher score represents better social support. |
| Adverse events during RCT | baseline, post treatment (2 weeks after baseline), 3 month after post treatment | A 6-item adverse events during RCT scale measures adverse events (score from 0 to 1, and total score varies from 0 to 6). A higher score represents adverse events. |
| Parent-adolescent relationship | baseline, post treatment (2 weeks after baseline), 3 month after post treatment | A 6-item parent-adolescent relationship scale measures parent-adolescent relationship (score from 0 to 4, and total score varies from 0 to 24). A higher score represents better parent-adolescent relationship. |
Countries
China