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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stress, Emotional; Stress-related Mental Disorders
• Intervention / Treatment: Behavioral: wait-list condition; Behavioral: Psychoeducation; Behavioral: guided written therapy

• Study Type: Interventional
• Enrollment (Estimated): 850
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zang Yinyin, PhD; Phone Number: +86 15553201610; Email: yinyin.zang@pku.edu.cn
• Study Contact Backup: Name: Feng Junkai, MSc; Phone Number: 86+15625013745

Study Locations

• China
  • Baoding
    • Hebei, Baoding, China, 071603
      • Recruiting
      • Biancun middle school
      • Contact: Liang Yachai; Phone Number: 86+ 03125217599

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TAU + delayed intervention; Participants in this group will receive treatment as usual (TAU), which includes standard school-based support services. They will not receive the study intervention during the trial period but will be offered the full intervention after final outcome assessments. This design enables comparison between the intervention and existing standard care, while ensuring ethical access to the intervention for all participants.	Behavioral: wait-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.
Experimental: intervention group; Participants in the intervention group will receive a structured psychological program consisting of four sessions delivered over the course of one week. Each session is 40 minutes in duration and includes approximately 20 minutes of psychoeducation followed by 20 minutes of a guided writing intervention. The sessions will cover the following core themes: ① chronic stress and emotional regulation, ② emotional identification and acceptance, ③ cognitive emotion regulation, and ④ the cognitive triangle. Interventions will be administered by trained graduate students in clinical psychology from Peking University. These facilitators will receive specialized training on the intervention protocol, and will conduct pre-intervention assessments and participate in regular supervision. All sessions will be audio and video recorded to monitor treatment fidelity, ensure adherence to the intervention manual, and support supervision and quality assurance procedures.	Behavioral: Psychoeducation; 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.; Behavioral: guided 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PTSD for adolescents	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.	baseline, post treatment (2 weeks after baseline), 3 month after post treatment
Depression	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.	baseline, post treatment (2 weeks after baseline), 3 month after post treatment
Insomnia Severity	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.	baseline, post treatment (2 weeks after baseline), 3 month after post treatment
Generalized anxiety disorder	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.	baseline, post treatment (2 weeks after baseline), 3 month after post treatment
Alexithymia	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.	baseline, post treatment (2 weeks after baseline), 3 month after post treatment
Emotion awareness	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.	baseline, post treatment (2 weeks after baseline), 3 month after post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resilience	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.	baseline, post treatment (2 weeks after baseline), 3 month after post treatment
Self-esteem	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.	baseline, post treatment (2 weeks after baseline), 3 month after post treatment
Subjective Happiness Scale	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.	baseline, post treatment (2 weeks after baseline), 3 month after post treatment
Frustration	The 25-item frustration scale (score from 1 to 5, and total score varies from 24 to 120). A higher score represents less frustration.	baseline, post treatment (2 weeks after baseline), 3 month after post treatment
Irritability	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.	baseline, post treatment (2 weeks after baseline), 3 month after post treatment
Cognitive emotion regulation	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.	baseline, post treatment (2 weeks after baseline), 3 month after post treatment
Game Addiction Scale	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.	baseline, post treatment (2 weeks after baseline), 3 month after post treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Suicide	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.	baseline, post treatment (2 weeks after baseline), 3 month after post treatment
Subjective Units of Distress Scale	A single item inquires about subjective distress on a 100-point scale. A higher score represents more subjective distress.	During intervention (up to 4 days)
Behavior performances	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.	baseline, post treatment (2 weeks after baseline), 3 month after post treatment
Adverse Childhood Experiences	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)	baseline, post treatment (2 weeks after baseline), 3 month after post treatment
Meaning in life	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.	baseline, post treatment (2 weeks after baseline), 3 month after post treatment
Non-suicidal self-injury	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.	baseline, post treatment (2 weeks after baseline), 3 month after post treatment
Somatic problems	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.	baseline, post treatment (2 weeks after baseline), 3 month after post treatment
EQ-5D-3L	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.	baseline, post treatment (2 weeks after baseline), 3 month after post treatment
Seeking for help	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.	baseline, post treatment (2 weeks after baseline), 3 month after post treatment
Positive Childhood Experiences	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.	baseline, post treatment (2 weeks after baseline), 3 month after post treatment
Social support	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.	baseline, post treatment (2 weeks after baseline), 3 month after post treatment
Adverse events during RCT	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.	baseline, post treatment (2 weeks after baseline), 3 month after post treatment
Parent-adolescent relationship	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.	baseline, post treatment (2 weeks after baseline), 3 month after post treatment
Shame	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.	baseline, post treatment (2 weeks after baseline), 3 month after post treatment

Collaborators and Investigators

• Sponsor: Peking University

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: May 12, 2025
• First Submitted That Met QC Criteria: August 4, 2025
• First Posted (Actual): August 11, 2025

Study Record Updates

• Last Update Posted (Actual): August 11, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: PTSD; randomized controlled trial; depression; anxiety; adolescents; rural area; stress-related mental disorders
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Behavioral Symptoms; Psychotic Disorders; Mental Disorders; Stress, Psychological
• Other Study ID Numbers: School interv. rural Adolscent

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No