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School-Based Intervention to Enhance Resilience and Stress Coping in Rural Chinese Adolescents

Enhancing Stress Resilience and Coping Skills Among Adolescents in Rural China Through School-Based Psychological Interventions: A Cluster Randomized Controlled Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07115186
Acronym
EASY
Enrollment
850
Registered
2025-08-11
Start date
2025-05-12
Completion date
2026-12-31
Last updated
2025-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress, Emotional, Stress-related Mental Disorders

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

BEHAVIORALPsychoeducation

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.

BEHAVIORALguided written therapy

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.

BEHAVIORALwait-list condition

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

Peking University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
Yes

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

MeasureTime frameDescription
PTSD for adolescentsbaseline, post treatment (2 weeks after baseline), 3 month after post treatmentThe 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.
Depressionbaseline, post treatment (2 weeks after baseline), 3 month after post treatmentThe 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 Severitybaseline, post treatment (2 weeks after baseline), 3 month after post treatmentThe 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 disorderbaseline, post treatment (2 weeks after baseline), 3 month after post treatmentThe 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.
Alexithymiabaseline, post treatment (2 weeks after baseline), 3 month after post treatmentA 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 awarenessbaseline, post treatment (2 weeks after baseline), 3 month after post treatmentA 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

MeasureTime frameDescription
Resiliencebaseline, post treatment (2 weeks after baseline), 3 month after post treatmentThe 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 Scalebaseline, post treatment (2 weeks after baseline), 3 month after post treatmentA 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-esteembaseline, post treatment (2 weeks after baseline), 3 month after post treatmentA 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 Scalebaseline, post treatment (2 weeks after baseline), 3 month after post treatmentA 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.
Frustrationbaseline, post treatment (2 weeks after baseline), 3 month after post treatmentThe 25-item frustration scale (score from 1 to 5, and total score varies from 24 to 120). A higher score represents less frustration.
Irritabilitybaseline, post treatment (2 weeks after baseline), 3 month after post treatmentA 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 regulationbaseline, post treatment (2 weeks after baseline), 3 month after post treatmentAn 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

MeasureTime frameDescription
Behavior performancesbaseline, post treatment (2 weeks after baseline), 3 month after post treatmentA 22-item behavior performance questionnaire measures various behavior performances such as study time, phone use, school performance, drinking alcohol, smoking, stealing, fighting, and lying.
Shamebaseline, post treatment (2 weeks after baseline), 3 month after post treatmentAn 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.
Suicidebaseline, post treatment (2 weeks after baseline), 3 month after post treatmentThe 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 ScaleDuring 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 Experiencesbaseline, post treatment (2 weeks after baseline), 3 month after post treatmentA 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 lifebaseline, post treatment (2 weeks after baseline), 3 month after post treatmentA 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-injurybaseline, post treatment (2 weeks after baseline), 3 month after post treatmentThe 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 problemsbaseline, post treatment (2 weeks after baseline), 3 month after post treatmentA 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-3Lbaseline, post treatment (2 weeks after baseline), 3 month after post treatmentThe 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 helpbaseline, post treatment (2 weeks after baseline), 3 month after post treatmentA 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 Experiencesbaseline, post treatment (2 weeks after baseline), 3 month after post treatmentA 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 supportbaseline, post treatment (2 weeks after baseline), 3 month after post treatmentThe 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 RCTbaseline, post treatment (2 weeks after baseline), 3 month after post treatmentA 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 relationshipbaseline, post treatment (2 weeks after baseline), 3 month after post treatmentA 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

Contacts

Primary ContactZang Yinyin, PhD
yinyin.zang@pku.edu.cn+86 15553201610
Backup ContactFeng Junkai, MSc
86+15625013745

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026