跳至主要内容
临床试验/NCT05199675
NCT05199675Unknown不适用

Implementing Digital Peer Support Training for Adolescent Mental Health: Study Protocol For A Type III Hybrid Randomized Controlled Trial

The N.1 Institute for Health (N.1)0 个研究点目标入组 100 人开始时间: 2022年1月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
100
主要终点
Change in Fidelity--Mattering

研究概览

简要总结

Using a hybrid type III trial with a cluster randomized design, the digital peer support training for adolescent mental health protocol aims to implement a multidisciplinary program, which translates theoretical and empirical work from implementation science, communication science, and developmental psychology, to train adolescents in effective digital peer support for mental well-being.

With the lack of theoretically driven and empirically grounded program to train adolescents in providing digital peer support for mental well-being, this study involves the design and implementation of such a program using that addressed four research questions:

(a) what is digital peer support for adolescents, (b) how do peers provide effective peer support online, (c) how do we implement digital peer support training among adolescents, (d) what are the facilitators and barriers in training adolescents to provide effective peer support, and (e) how do we scale up and sustain digital peer support training among adolescents for far-reaching and long-lasting effectiveness?

详细描述

Background: The digital peer support training for adolescent mental health project aims to implement a multidisciplinary program, which translates theoretical and empirical work from implementation science, communication science, and developmental psychology, to train adolescents in effective digital peer support for mental well-being. Nearly 50% of all mental health issues has an early onset in adolescence, and mental health conditions have long lasting and far-reaching effects for adolescents. Although there is an emerging body of work that underscores digital platform as an important interpersonal context for peer support in managing well-being in adolescence, there is no implementation of an evidence-based intervention to train adolescents in effective online peer support.

Methods: Using a hybrid type III trial with a cluster randomized design, a total of 100 Singaporean students from 4 classes in a high school will be randomly allocated to the intervention or wait-list control arm. The intervention arm will undergo bite size modules on the four active ingredients of youth mental well-being-specifically, Mattering, selfhood, compassion and mindfulness, which will be delivered through training workshops, simulation activities, and homework assignments. Students in the wait-list control arm will receive the the training program after the conclusion of the trial with the intervention arm. The pre-post with control evaluation design will be utilized to evaluate program outcomes. Fidelity will be the primary outcome assessed to demonstrate the effectiveness of the digital peer support training program. It will be measured by the extent to which adolescents' responses to real-cases of peer disclosure indicate Mattering, selfhood, compassion and mindfulness. Reach, acceptability, cost-effectiveness, and adolescent self-reported psychological well-being will be assessed as secondary outcomes. Cost-effectiveness analysis will inform the development of a scalability and sustainability plan.

Data Collection, Management and Analyses: We conducted power analysis using to ascertain the adequate sample size needed for the randomized controlled trial, specifically in comparing the intervention and control groups on different implementation and clinical outcomes, so that the study has sufficient power to detect valid effects. The study sample size of n = 50 for intervention and n = 50 for control is needed because of multiple dependent variables measuring implementation outcomes included in the study--specifically, fidelity, reach, acceptability, and cost-effectiveness, and the testing of the clinical outcome on psychological well-being.

Missing data In dealing with missing data, we will determine if missing data is missing completely at random. If missing data is not systematic, as indicated by the non-significant result from Little's Missing Completely at Random Test, we will handle missing data using full information maximum likelihood imputation.

Qualitative analysis We will conduct qualitative analyses with NVivo 10 on the secondary outcome on acceptability of the program. This outcome data will be gathered from both the adolescents and their teachers using focus group discussions post-intervention to elucidate the facilitators and barriers at the individual and organization levels that contribute to and hinder adolescents in providing effective digital peer support, respectively. Participants' responses will be subjected to topic modelling using Latent Dirichlet Allocation (LDA) analyses with R to filter the huge amount of data available and drill down relevant themes and topics. LDA is an advanced statistical method that increases precision and accuracy in coding.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
13 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Participants will include certified teachers aged 22 to 65 with a post-graduate diploma in education and who teach the Character and Citizenship Education lessons, as well as adolescents aged 13 to 16 who are students enrolled in the high school.

排除标准

  • •Students who have been identified by the school teachers and counselors prior to the training as experiencing emotional distress will be excluded. Additionally, as one of the secondary outcomes examined in this study, students with low ratings of psychological well-being (Ryff & Keyes, 1995; i.e., 2 SD below the mean) in the pre-training assessment will be referred to the teachers and school counselors and they will not participate in the workshop.

研究组 & 干预措施

Digital Peer Support Training Program

Experimental

The intervention arm will undergo bite size modules on the four active ingredients of youth mental well-being-specifically, Mattering, selfhood, compassion and mindfulness, which will be delivered through training workshops, simulation activities, and homework assignments. The pre-post with control evaluation design will be utilized to evaluate program outcomes. Fidelity will be the primary outcome assessed to demonstrate the effectiveness of the digital peer support training program. It will be measured by the extent to which adolescents' responses to real-cases of peer disclosure indicate Mattering, selfhood, compassion and mindfulness. Reach, acceptability, cost-effectiveness, and adolescent self-reported psychological well-being will be assessed as secondary outcomes. Cost-effectiveness analysis will inform the development of a scalability and sustainability plan.

干预措施: Digital Peer Support Training Program (Behavioral)

Waitlist control for Digital Peer Support Training Program

Active Comparator

Students in the wait-list control arm will receive the training program after the conclusion of the trial with the intervention arm. The pre-post with control evaluation design will be utilized to evaluate program outcomes. The intervention arm will undergo bite size modules on the four active ingredients of youth mental well-being-specifically, Mattering, selfhood, compassion and mindfulness, which will be delivered through training workshops, simulation activities, and homework assignments.The same set of primary and secondary outcomes assessed in the experimenter arm will be included. Specifically, fidelity will be the primary outcome assessed. Reach, acceptability, cost-effectiveness, and adolescent self-reported psychological well-being will be assessed as secondary outcomes.

干预措施: Digital Peer Support Training Program (Behavioral)

结局指标

主要结局

Change in Fidelity--Mattering

时间窗: Before and immediately after training (as pre-class activity and homework assignment, respectively)

The degree to which the program is delivered as intended--specifically, fidelity will be measured by the extent to which adolescents' responses to real-world cases of peer disclosure indicate Mattering, using the 5-item Rosenberg Mattering Scale (Rosenberg \& McCullough, 1981) on a 5-point scale 0 (not at all) to 4 (very much). Before and immediately after training (as pre-class activity and homework assignment, respectively), participants in both the intervention arm will be presented with three cases of peer disclosure of varying levels of complexity and social context/issues (i.e., family, school, and relationship).

Change in Fidelity--Selfhood

时间窗: Before and immediately after training (as pre-class activity and homework assignment, respectively)

The degree to which the program is delivered as intended--specifically, fidelity will be measured by the extent to which adolescents' responses to real-world cases of peer disclosure indicate selfhood using the 10-item Rosenberg Global Self-Esteem Scale (Rosenberg, 1989), rated on a 5-point scale 0 (not at all) to 4 (very much). Before and immediately after training (as pre-class activity and homework assignment, respectively), participants in both the intervention arm will be presented with three cases of peer disclosure of varying levels of complexity and social context/issues (i.e., family, school, and relationship).

Change in Fidelity--compassion

时间窗: Before and immediately after training (as pre-class activity and homework assignment, respectively)

The degree to which the program is delivered as intended--specifically, fidelity will be measured by the extent to which adolescents' responses to real-world cases of peer disclosure indicate compassion as operationalized in the Compassion Cultivation Training protocol (Jazaieri et al., 2013) as a multidimensional process comprising of four key components. Each component will be rated on a 5-point scale 0 (not at all) to 4 (very much). Before and immediately after training (as pre-class activity and homework assignment, respectively), participants in both the intervention arm will be presented with three cases of peer disclosure of varying levels of complexity and social context/issues (i.e., family, school, and relationship).

Change in Fidelity--Mindfulness

时间窗: Before and immediately after training (as pre-class activity and homework assignment, respectively)

The degree to which the program is delivered as intended--specifically, fidelity will be measured by the extent to which adolescents' responses to real-world cases of peer disclosure indicate indicate mindfulness using the Cognitive theory of mindfulness(Carson \& Langer, 2006). Participants' responses will be evaluated based on the extent in which they reflect/harness the techniques for enhancing mindful self-acceptance in their responses using a 5-point scale 0 (not at all) to 4 (very much). Before and immediately after training (as pre-class activity and homework assignment, respectively), participants in both the intervention arm will be presented with three cases of peer disclosure of varying levels of complexity and social context/issues (i.e., family, school, and relationship).

次要结局

  • Reach(Immediately after the training program/last session of the training workshop)
  • Acceptability--Self-report(Immediately after the training program/last session of the training workshop)
  • Acceptability--focus group discussions(Immediately after the training program/last session of the training workshop)
  • Cost-effectiveness(Immediately after the training program/last session of the training workshop)
  • Psychological well-being(Immediately after the training program/last session of the training workshop)

研究者

发起方
The N.1 Institute for Health (N.1)
申办方类型
Other
责任方
Sponsor

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