School-Based Intervention to Enhance Resilience and Stress Coping in Rural Chinese Adolescents
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-18
SponsorPeking University
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Psychoeducation
BehavioralPsychoeducation 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.
guided written therapy
BehavioralIn 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.
wait-list condition
BehavioralParticipants 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.
Treatment groups
850 Participants
are divided into 2 treatment groupsGroup A: TAU + delayed interventionActive comparator 1 intervention
Group B: intervention groupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
baseline, post treatment (2 weeks after baseline), 3 month after post treatment2
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.
Time frame
baseline, post treatment (2 weeks after baseline), 3 month after post treatment3
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.
Time frame
baseline, post treatment (2 weeks after baseline), 3 month after post treatment4
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.
Time frame
baseline, post treatment (2 weeks after baseline), 3 month after post treatmentSecondary outcomes
1
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.
Time frame
baseline, post treatment (2 weeks after baseline), 3 month after post treatment2
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.
Time frame
baseline, post treatment (2 weeks after baseline), 3 month after post treatment3
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.
Time frame
baseline, post treatment (2 weeks after baseline), 3 month after post treatment4
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.
Time frame
baseline, post treatment (2 weeks after baseline), 3 month after post treatmentOther outcomes
1
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.
Time frame
baseline, post treatment (2 weeks after baseline), 3 month after post treatment2
Subjective Units of Distress Scale
A single item inquires about subjective distress on a 100-point scale. A higher score represents more subjective distress.
Time frame
During intervention (up to 4 days)3
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.
Time frame
baseline, post treatment (2 weeks after baseline), 3 month after post treatment4
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)
Time frame
baseline, post treatment (2 weeks after baseline), 3 month after post treatmentSponsors and contacts
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Source ClinicalTrials.gov