Mental Health IssueNCT05979649
An Internet-Based Intervention With Peer Support for the Mental Health of Youths
A study testing behavioral corrective tasks, Counselling on psychological knowledge and Peer Interventionist Training in people with Mental Health Issue, run by Wei XIA, PhD at 1 site in China.
Trial summary
The aim of this randomized control trial study is to develop an online intervention project that specifically targets and addresses mental health issues among youths in the post-pandemic era, while also assessing its effectiveness. Read more about this study
- Who is it for?
- Ages 14 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- behavioral corrective tasks, Counselling on psychological knowledge and Peer Interventionist Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Sep 2023to Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
- 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.
Who cannot join
- Individuals currently undergoing clinical psychotherapy or participating in other interventional studies.
- Individuals diagnosed with psychological or mental disorders.
- Peer intervener group：
- Individuals currently undergoing clinical psychotherapy or participating in other interventional studies.
- Individuals diagnosed with psychological or mental disorders.
Trial locations and contacts
1 site in 1 country.
China1 site
XIAW
Guangzhou, Guangdong, 510080
Wei Xia, PhD, 18823359471, xiaw23@mail.sysu.edu.cn
About this study
Official title: The Effectiveness of an Internet-Based Intervention With Peer Support for the Mental Health of Youths: A Randomized Controlled Trial
The aim of this randomized control trial study is to develop an online intervention project that specifically targets and addresses mental health issues among youths in the post-pandemic era, while also assessing its effectiveness. Additionally, this intervention project has the potential to effectively address other post-traumatic conditions experienced by youths. Furthermore, our research group will investigate the specific impacts of long-term interventions on various aspects including changes in mental health status, psychological resilience, coping strategies, perceived social support, and emotional intelligence among the participants.
Read the 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.
- Conditions
- Mental Health Issue
- Being tested
- behavioral corrective tasks, Counselling on psychological knowledge, placebo-controlled study, Peer Interventionist Training
- Keywords
- adolescent, internet-based, peer support, post-pandemic era, stressful life event, Coping Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavioral corrective tasksBehavioural
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 knowledgeOther
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-controlled studyOther
"feel-good" articles without professional psychological knowledge will be sent to the control group participants weekly.
Peer Interventionist TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | 1. Throughout the intervention period, we will deliver weekly customized feeds to youths at a consistent time, covering stressful events, coping strategies, social support, and emotional intelligence, totaling eight deliveries.
2. After peer interveners (peer mentors) receive counseling credentials, every fifth participant will be randomly paired with a peer intervener. Over the next eight weeks, they will engage in individualized conversations via online video conferences biweekly.The intervention will last eight weeks, with four conversations in total.
3. After each personalized conversation, the interveners will collaboratively develop behavioral corrective tasks for the following two weeks from the "To Do List," including at least one task from each category: social support, coping strategies, and emotional intelligence. During the next conversation, the interveners will inquire about the participants' completion status and personal experiences. Receives: Behavioral: behavioral corrective tasks; Other: Counselling on psychological knowledge |
| control group | Placebo comparator | 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. Receives: Other: placebo-controlled study |
| Peer intervener group | Other | 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. Receives: Other: Peer Interventionist Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ability to cope with stressful situations
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.
Measured: Baseline,2 months，4 months
The level of emotional intelligence
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.
Measured: Baseline,2 months，4 months
The mental health level of the youths
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.
Measured: Baseline,2 months，4 months
The participants' somatization symptoms, anxiety, and depression status
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.
Measured: Baseline,2 months，4 months
The perceived level of social support system for oneself
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.
Measured: Baseline,2 months，4 months
Subjects' mental toughness Connor-Davidson resilience scale
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.
Measured: Baseline,2 months，4 months
Secondary outcomes (2)
The extent of negative impact caused by stressful life events.
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.
Measured: Baseline,2 months，4 months
The level of social support received. Social Support Rating Scale
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.
Measured: Baseline,2 months，4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study startSep 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wei XIA, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wei XIA, PhD, Sun Yat-sen University
- Investigators
- Wei Xia, PhD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05979649
- Sponsor's protocol ID
- L2023SYSU-HL-010
- Status last verified
- Aug 2023
- First submitted
- 29 Jul 2023
- Last updated
- 9 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The non-identified IPD will be shared after the outcomes have been published.
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of an Internet-Based Intervention With Peer Support for the Mental Health of Youths: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05979649
- Acronym / sponsor ID
- L2023SYSU-HL-010
- Conditions
- Mental Health Issue
- Keywords
- adolescent, internet-based, peer support, post-pandemic era, stressful life event, Coping Behavior
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Wei XIA, PhDUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 7 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this randomized control trial study is to develop an online intervention project that specifically targets and addresses mental health issues among youths in the post-pandemic era, while also assessing its effectiveness. Additionally, this intervention project has the potential to effectively address other post-traumatic conditions experienced by youths. Furthermore, our research group will investigate the specific impacts of long-term interventions on various aspects including changes in mental health status, psychological resilience, coping strategies, perceived social support, and emotional intelligence among the participants.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: behavioral corrective tasks, Other: Counselling on psychological knowledge1. Throughout the intervention period, we will deliver weekly customized feeds to youths at a consistent time, covering stressful events, coping strategies, social support, and emotional intelligence, totaling eight deliveries. 2. After peer interveners (peer mentors) receive counseling credentials, every fifth participant will be randomly paired with a peer intervener. Over the next eight weeks, they will engage in individualized conversations via online video conferences biweekly.The intervention will last eight weeks, with four conversations in total. 3. After each personalized conversation, the interveners will collaboratively develop behavioral corrective tasks for the following two weeks from the "To Do List," including at least one task from each category: social support, coping strategies, and emotional intelligence. During the next conversation, the interveners will inquire about the participants' completion status and personal experiences. |
| control group | Placebo comparator | Other: placebo-controlled studyThroughout 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. |
| Peer intervener group | Other | Other: Peer Interventionist TrainingPeer 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. |
Who may qualify
- Ages
- 14 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
- Aged 18-25
- Individuals with a Bachelor's degree in progress or higher, and a professional background in sociology, psychology, education, or medicine.
Key exclusion criteria (5 listed)
- Individuals currently undergoing clinical psychotherapy or participating in other interventional studies.
- Individuals diagnosed with psychological or mental disorders.
- Peer intervener group：
- Individuals currently undergoing clinical psychotherapy or participating in other interventional studies.
- Individuals diagnosed with psychological or mental disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| behavioral corrective tasksAfter 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. | Behavioural | experimental group |
| Counselling on psychological knowledgeCounselling 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. | Other | experimental group |
| placebo-controlled study"feel-good" articles without professional psychological knowledge will be sent to the control group participants weekly. | Other | control group |
| Peer Interventionist TrainingThe training is a one-day course, encompassing a broad range of topics, including but not limited to counseling techniques and specialized medical psychology knowledge. | Other | Peer intervener group |
Primary outcome
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.
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.
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.
The participants' somatization symptoms, anxiety, and depression status
Time frame: Baseline,2 months，4 months
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.
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.
Subjects' mental toughness Connor-Davidson resilience scale
Time frame: Baseline,2 months，4 months
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.
2 secondary outcomes
The extent of negative impact caused by stressful life events.
Time frame: Baseline,2 months，4 months
The level of social support received. Social Support Rating Scale
Time frame: Baseline,2 months，4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
- Individual participant dataSharing planned: Yes. The non-identified IPD will be shared after the outcomes have been published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Xia, PhD principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing behavioral corrective tasks, Counselling on psychological knowledge and Peer Interventionist Training in people with Mental Health Issue, run by Wei XIA, PhD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Xia, PhD (18823359471, xiaw23@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ability to cope with stressful situations (time frame: Baseline,2 months，4 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2023.