NCT05199675

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?

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
11 days until next milestone

Study Start

First participant enrolled

January 31, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

January 20, 2022

Status Verified

January 1, 2022

Enrollment Period

11 months

First QC Date

December 15, 2021

Last Update Submit

January 6, 2022

Conditions

Keywords

Hybrid III trial,AdolescenceDigital peer supportMental HealthImplementation ScienceCommunication ScienceDevelopmental psychology

Outcome Measures

Primary Outcomes (4)

  • Change in Fidelity--Mattering

    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).

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

  • Change in Fidelity--Selfhood

    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).

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

  • Change in Fidelity--compassion

    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).

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

  • Change in Fidelity--Mindfulness

    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).

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

Secondary Outcomes (5)

  • 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

Study Arms (2)

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.

Behavioral: Digital Peer Support Training Program

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.

Behavioral: Digital Peer Support Training Program

Interventions

The digital peer support training program will consist of bite size modules on the four active ingredients of youth mental well-being, which will be delivered through training workshops, simulation activities, and homework assignments. The training will be conducted over 8 sessions, each lasting for 45-60 minutes following the typical duration of a school lesson on Character and Citizenship Education. The training workshops will be conducted as part of the school's Character and Citizenship Education lessons. The proficiency of participants in applying these digital support skills will be evaluated through simulation and homework activities, in which they apply the four active ingredients in their responses to mock letters that are adapted from actual cases of peer emotional disclosure. At the end of the training, adolescents are expected to apply the four active ingredients to the homework assignments on peers' emotional experiences.

Digital Peer Support Training ProgramWaitlist control for Digital Peer Support Training Program

Eligibility Criteria

Age13 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (50)

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    BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • GeckHong Yeo, PhD

    N.1 Institute for Health, National University of Singapore

    PRINCIPAL INVESTIGATOR
  • Dean Ho, PhD

    N.1 Institute for Health, National University of Singapore

    PRINCIPAL INVESTIGATOR
  • Wei Ning Chang, PhD

    Institute of Mental Health, Singapore

    PRINCIPAL INVESTIGATOR
  • Bradford Brown, PhD

    University of Wiscosnsin, Madison; Department of Educational Psychology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

GeckHong Yeo, PhD

CONTACT

Dean Ho, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2021

First Posted

January 20, 2022

Study Start

January 31, 2022

Primary Completion

December 31, 2022

Study Completion

December 1, 2023

Last Updated

January 20, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported in article publication, after deidentification (text, tables, figures, and appendices)

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Beginning 12 months and ending 36 months following article publication
Access Criteria
Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose-for individual participant data meta-analysis. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata.