Clinical trial NCT05199675: Implementing Digital Peer Support Training for Adolescent Mental Health
Official title: Implementing Digital Peer Support Training for Adolescent Mental Health: Study Protocol For A Type III Hybrid Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adolescent Development
Peer Group
Mental Health Wellness 1
Keywords: Hybrid III trial,
Adolescence
Digital peer support
Mental Health
Implementation Science
Communication Science
Developmental psychology
Lead sponsor: The N.1 Institute for Health (N.1)
Sponsor class: OTHER
Collaborators: name: Manjusri Secondary School, Singapore
First posted: 2022-01-20
Enrollment: 100
Sex: ALL
Minimum age (years): 13
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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?

Detailed description: 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.

Quantitative analysis The paired-sample t test for continuous variables will be conducted with the intervention group to compare the pre- (i.e., first time point) and post-training scores (second time point) for the four active ingredients and we expect that the change score will be significant. Likewise, for the wait-list control group, their scores for the same two time-points will be assessed and it is expected that the change score will not be significant. The independent sample t-tests will be conducted to compare the intervention and control groups' scores at the first and second time points. For the first time point, we anticipate the difference between the intervention and control groups to be non-significant. Participants in both arms are expected to have comparable initial level of digital peer support skills-specifically, their knowledge of and competency in harnessing the four active ingredients in responding to real cases of peer disclosure. On the contrary, for the second time point, the difference between the intervention and control groups is anticipated to be significant, with the former indicating a higher composite score of effective peer support, if the digital peer support training program is effective.

Discussion: The digital peer support training trial adopts a multidisciplinary approach to implement a theoretically grounded and evidence-based practice for training adolescents to be effective peer supporters online-an important precursor in implementing relevant and impactful digital peer support intervention for youth mental well-being.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in Fidelity--Mattering
timeFrame: Before and immediately after training (as pre-class activity and homework assignment, respectively)
measure: Change in Fidelity--Selfhood
timeFrame: Before and immediately after training (as pre-class activity and homework assignment, respectively)
measure: Change in Fidelity--compassion
timeFrame: Before and immediately after training (as pre-class activity and homework assignment, respectively)
measure: Change in Fidelity--Mindfulness
timeFrame: Before and immediately after training (as pre-class activity and homework assignment, respectively)
Secondary outcomes:
measure: Reach
timeFrame: Immediately after the training program/last session of the training workshop
measure: Acceptability--Self-report
timeFrame: Immediately after the training program/last session of the training workshop
measure: Acceptability--focus group discussions
timeFrame: Immediately after the training program/last session of the training workshop
measure: Cost-effectiveness
timeFrame: Immediately after the training program/last session of the training workshop
measure: Psychological well-being
timeFrame: Immediately after the training program/last session of the training workshop
Other outcomes:
Locations:
Study officials:
affiliation: N.1 Institute for Health, National University of Singapore
name: GeckHong Yeo, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: N.1 Institute for Health, National University of Singapore
name: Dean Ho, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Mental Health, Singapore
name: Wei Ning Chang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Wiscosnsin, Madison; Department of Educational Psychology
name: Bradford Brown, PhD
role: PRINCIPAL_INVESTIGATOR
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