An Internet-Based Intervention With Peer Support for the Mental Health of Youths

NCT05979649 | Unknown DMC

• 1 other identifier: L2023SYSU-HL-010
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Mental Health Issue

Keywords

adolescent; internet-based; peer support; post-pandemic era; stressful life event; Coping Behavior

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  Baseline,2 months，4 months

Secondary Outcomes (2)

• The extent of negative impact caused by stressful life events.

  Baseline,2 months，4 months

• The level of social support received. Social Support Rating Scale

  Baseline,2 months，4 months

Study Arms (3)

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.

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.

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.

Other: Peer Interventionist Training

Interventions

behavioral corrective tasks BEHAVIORAL

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.

experimental group

Counselling on psychological knowledge OTHER

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.

experimental group

placebo-controlled study OTHER

"feel-good" articles without professional psychological knowledge will be sent to the control group participants weekly.

control group

Peer Interventionist Training OTHER

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.

Peer intervener group

Eligibility Criteria

• Age: 14 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Individuals currently undergoing clinical psychotherapy or participating in other interventional studies.
• Individuals diagnosed with psychological or mental disorders.
• Peer intervener group：
• 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.
• Individuals currently undergoing clinical psychotherapy or participating in other interventional studies.
• Individuals diagnosed with psychological or mental disorders.

Sponsors & Collaborators

• Wei XIA, PhD: lead

Study Sites (1)

XIAW

Guangzhou, Guangdong, 510080, China

Location

Study Officials

• Wei Xia, PhD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Xia, PhD

CONTACT

18823359471; xiaw23@mail.sysu.edu.cn

Hexiao Ding

CONTACT

13979305061; jxdhx@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 29, 2023
• First Posted: August 7, 2023
• Study Start: September 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: February 1, 2024
• Last Updated: August 9, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: After the publication of the study
• Access Criteria: Researchers should contact the PI for approval of the study protocol.

Locations

CN (1)