NCT07115186

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
850

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress60%
May 2025Dec 2026

First Submitted

Initial submission to the registry

May 12, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

May 12, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 11, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

1.1 years

First QC Date

May 12, 2025

Last Update Submit

August 4, 2025

Conditions

Keywords

adolescentsrandomized controlled trialPTSDdepressionanxietystress-related mental disordersrural area

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (7)

  • Resilience

    baseline, post treatment (2 weeks after baseline), 3 month after post treatment

  • Self-esteem

    baseline, post treatment (2 weeks after baseline), 3 month after post treatment

  • Subjective Happiness Scale

    baseline, post treatment (2 weeks after baseline), 3 month after post treatment

  • Frustration

    baseline, post treatment (2 weeks after baseline), 3 month after post treatment

  • Irritability

    baseline, post treatment (2 weeks after baseline), 3 month after post treatment

  • +2 more secondary outcomes

Other Outcomes (14)

  • Suicide

    baseline, post treatment (2 weeks after baseline), 3 month after post treatment

  • Subjective Units of Distress Scale

    During intervention (up to 4 days)

  • Behavior performances

    baseline, post treatment (2 weeks after baseline), 3 month after post treatment

  • +11 more other outcomes

Study Arms (2)

TAU + delayed intervention

ACTIVE COMPARATOR

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

intervention group

EXPERIMENTAL

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: PsychoeducationBehavioral: guided written therapy

Interventions

PsychoeducationBEHAVIORAL

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.

intervention group

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.

intervention group

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.

TAU + delayed intervention

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biancun middle school

Hebei, Baoding, 071603, China

RECRUITING

MeSH Terms

Conditions

Stress, PsychologicalStress Disorders, Post-TraumaticDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorStress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Central Study Contacts

Feng Junkai, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 12, 2025

First Posted

August 11, 2025

Study Start

May 12, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

August 11, 2025

Record last verified: 2025-08

Locations