- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05979649
An Internet-Based Intervention With Peer Support for the Mental Health of Youths
The Effectiveness of an Internet-Based Intervention With Peer Support for the Mental Health of Youths: A Randomized Controlled Trial
Study Overview
Status
Conditions
Detailed Description
Over the past decade, mental health issues have become increasingly prevalent among young people. Approximately 14% of adolescents aged 10-19 years globally suffer from conditions like depression and anxiety. This is concerning because adolescence is a critical period for development, and these mental health problems can have long-term consequences on various aspects of their lives, including relationships, education, and work.
The mental health of young people (15-24) is a significant global concern, affecting one in five individuals within this age group and representing the largest burden of illness. Moreover, the impact of mental health problems during adolescence can extend into adulthood, affecting physical and mental well-being and limiting opportunities for a fulfilling life.
According to the World Health Organization (WHO), mental health and psychosocial well-being are essential for youth's human potential and rights. However, the COVID-19 pandemic has exacerbated mental health problems among adolescents, leading to disruptions in critical mental health services in many countries. Studies have shown that the pandemic has resulted in increased depression, anxiety, stress, and sleep disorders among young people. Additionally, the previously mentioned conditions faced by adolescents have worsened to the point of mental disorders and suicide attempts.
The impact of the pandemic on youths' mental health has drawn global attention and highlights the urgency of intervening in their mental well-being. Stressors among young people primarily come from academics, employment, relationships, appearance, finances, etc. The lack of effective coping strategies and emotional regulation further exacerbate physical health symptoms and negative consequences. Unfortunately, a significant number of young people experiencing mental health problems do not seek professional help, primarily due to denial, embarrassment, lack of time, and stigma. They often turn to informal resources such as family, friends, books, or counseling websites, with uncertain effectiveness. Long waiting lists for psychological services add to the dilemma. Therefore, it is crucial to help youths overcome these barriers when providing support services.
Currently, access to cost-effective and accessible mental health services remains challenging for young people. In addition to counseling and psychiatric services, peer support has emerged as a novel resource for young people seeking help. Peer support involves social and emotional support from individuals with similar experiences. Research suggests that peer support is an accessible, affordable, and easily implemented mental health resource. Involving peer supporters in mental health services can promote recovery and has positive effects on depressive symptoms, anxiety, psychological distress, self-esteem, self-efficacy, and self-management. However, there is a lack of research on the development and implementation of peer-support based interventions for adolescents with psychological problems. This study aims to address this gap.
Given the concerns surrounding psychological problems among young people, this study aims to design a pragmatic and comprehensive peer support-based intervention. The intervention will be based on the Youth Stressful Life Event Response Model, which explains how adolescents respond to stress and how factors like emotional intelligence, social support, and coping strategies impact their mental health. This online, single-blind, randomized controlled trial will include both an intervention group and a control group. The control group will receive motivational articles unrelated to the main monitoring indicators. Participants will be assessed at baseline, post-intervention, and during follow-up. Through the implementation of a peer support program, this study aims to investigate the specific effects of long-term intervention on changes in mental health status, psychological resilience, perceived social support, and emotional intelligence.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hexiao Ding
- Phone Number: 13979305061
- Email: jxdhx@qq.com
Study Contact Backup
- Name: wei Xia, PhD
- Phone Number: 18823359471
- Email: xiaw23@mail.sysu.edu.cn
Study Locations
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-
Guangdong
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Guangzhou, Guangdong, China, 510080
- XIAW
-
Contact:
- wei Xia, PhD
- Phone Number: 18823359471
- Email: xiaw23@mail.sysu.edu.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Experimental group and control group:
Inclusion Criteria:
- Aged 14-25
- Individuals who have experienced a stressful life event of moderate or greater magnitude within the past six months (with a moderate impact on one or more of the Stressful Events Scale screenings).
- Individuals who can provide informed consent and willingly cooperate with this study
Exclusion Criteria:
- Individuals currently undergoing clinical psychotherapy or participating in other interventional studies.
- Individuals diagnosed with psychological or mental disorders.
Peer intervener group:
Inclusion Criteria:
- Aged 18-25
- Individuals with a Bachelor's degree in progress or higher, and a professional background in sociology, psychology, education, or medicine.
- Individuals who can provide informed consent and willingly cooperate with this study.
Exclusion Criteria:
- Individuals currently undergoing clinical psychotherapy or participating in other interventional studies.
- Individuals diagnosed with psychological or mental disorders.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: experimental group
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After each personalized conversation, the interveners will, based on a clear understanding of the participants' completion status and personal experiences with the previous "behavioral corrective tasks," assist in formulating future "behavioral corrective tasks" for the next two weeks.
These tasks will be selected from our designated "To Do List," requiring at least one task from each category: social support, coping strategies, and emotional intelligence.
Counselling on psychological knowledge includes weekly personalized feeds, as well as the methods and techniques for coping with challenges provided by the interveners.during
personalized conversations with the participants.
|
|
Placebo Comparator: control group
Throughout the eight weeks of intervention, articles without professional psychological knowledge will be delivered to the control group participants once a week at a consistent time, totaling eight deliveries in total.
|
"feel-good" articles without professional psychological knowledge will be sent to the control group participants weekly.
|
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Other: Peer intervener group
Peer interveners will participate in a one-day course conducted by several instructors with backgrounds in psychology and medicine.
They will be required to pass a "standardized patient test" after the course to obtain the qualification for intervention.
|
The training is a one-day course, encompassing a broad range of topics, including but not limited to counseling techniques and specialized medical psychology knowledge.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The ability to cope with stressful situations
Time Frame: Baseline,2 months,4 months
|
The change of the scores of various dimensions in the Stressful Situation Coping Scale - Chinese short(CISS-SFC) among youths during the intervention period and follow-up period.This scale is divided into four dimensions: task-oriented coping, emotion-oriented coping, distraction coping, and social diversion coping.Each item consists of four statements (scoredfrom 0 to 3) describing depressive symptoms, with higher scores indicating greater severity.
Scores on eachitem are summed to yield a total score on the measure from 0 to 63.
|
Baseline,2 months,4 months
|
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The level of emotional intelligence
Time Frame: Baseline,2 months,4 months
|
The change of the Wong and Law Emotional Intelligence Scale(WLEIS) scores of youths during the intervention and follow-up periods.This scale includes four sub-scales: appraisal and expression of emotion in oneself, appraisal and recognition of emotion in others, regulation of emotion in oneself, and use of emotion to facilitate performance.The scale score ranges from 16 to 112.The higher the score, the better the emotional intelligence of youths.
|
Baseline,2 months,4 months
|
|
The mental health level of the youths
Time Frame: Baseline,2 months,4 months
|
The change of the Brief Symptom Inventory-53(BSI-53) scores of youths during the intervention and follow-up periods.The minimum score on the scale is 0.The sum of all items' scores reaching 63 and above was considered "BSI-positive" .The lower the score, the milder the psychological problem symptoms of youths.
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Baseline,2 months,4 months
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The participants' somatization symptoms, anxiety, and depression status
Time Frame: Baseline,2 months,4 months
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The change of the Brief Symptom Inventory-18(BSI-18) scores of youths during the intervention and follow-up periods.The scale has a minimum score of 0 and a maximum score of 72.
The higher the score, the worse the psychological well-being of adolescents.
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Baseline,2 months,4 months
|
|
The perceived level of social support system for oneself
Time Frame: Baseline,2 months,4 months
|
The change of the Perceived Social Support Scale(PSSS) scores during the intervention and follow-up periods.The scale score ranges from 7 to 84, and the higher the score, the greater the perceived level of social support by the participants.
|
Baseline,2 months,4 months
|
|
Subjects' mental toughness Connor-Davidson resilience scale
Time Frame: Baseline,2 months,4 months
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The change of the Connor-Davidson resilience scale scores during the intervention and follow-up periods.The scale has a minimum score of 0 and a maximum score of 100.
The higher the score, the better the psychological resilience of the participants.
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Baseline,2 months,4 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The extent of negative impact caused by stressful life events.
Time Frame: Baseline,2 months,4 months
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The change of the Adolescent Self-Rating Life Events Check-List scale(ASLEC) scores of youths during the intervention period and follow-up period.The scores on the scale range from 0 (with the lowest score being 3 for participants meeting the inclusion criteria of this study) to 135.
A higher score indicates a greater impact of stressful life events on the participants.
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Baseline,2 months,4 months
|
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The level of social support received. Social Support Rating Scale
Time Frame: Baseline,2 months,4 months
|
The change of the Social Support Rating Scale(SSRS) scores during the intervention and follow-up periods.This scale includes objective support, subjective support, and utilization of support.The sum of all scores from the three subscales to obtain aggregate scores for the SSRS.
A higher score indicates a higher level of social support.
|
Baseline,2 months,4 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wei Xia, Phd, Sun Yat-sen University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- L2023SYSU-HL-010
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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