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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05199675
Other study ID # NUS-IRB-2021-761
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 31, 2022
Est. completion date December 2023

Study information

Verified date January 2022
Source The N.1 Institute for Health (N.1)
Contact GeckHong Yeo, PhD
Phone 66017766
Email LSIGHY@nus.edu.sg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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?


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date December 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 13 Years to 65 Years
Eligibility 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.

Study Design


Intervention

Behavioral:
Digital Peer Support Training Program
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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
The N.1 Institute for Health (N.1) Manjusri Secondary School, Singapore

References & Publications (50)

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* Note: There are 50 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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)
Primary 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)
Primary 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 Reach The number of adolescents who received the training divided by the number of eligible adolescents from the four classes (clusters), will be established. Immediately after the training program/last session of the training workshop
Secondary Acceptability--Self-report We will measure acceptability from the perspective of both adolescents and their teachers using a self-report questionnaire post-intervention-specifically, at the last session of the training program.
Participants will provide responses to the Client Satisfaction Questionnaire (CSQ-8; Attkisson & Greenfield, 1994), with 8 items that measure the degree of client satisfaction with services and will be rated on a 4-point scale ranging from 1 (poor) to 4 (excellent).
Immediately after the training program/last session of the training workshop
Secondary Acceptability--focus group discussions We will measure acceptability from the perspective of both adolescents and their teachers using focus group discussions post-intervention-specifically at the last session of the training program, which will be audio-recorded and transcribed using pseudonyms to ensure confidentiality.
Following the implementation steps delineated in the GTO framework (Wandersman et al., 2000), the focus group interviews with groups of 3 to 4 participants will elucidate facilitators and barriers at the individual level-specifically, factors that contribute to or hinder adolescents in providing effective digital peer support. At the organizational level, we will assess the fit of the training program within the school context by addressing the four primary questions listed earlier in the section on program implementation
Immediately after the training program/last session of the training workshop
Secondary Cost-effectiveness To estimate the cost of implementing the training program, which functions as important information for the research team as well as the participating organization in assessing the resources needed to scale up and sustain the program within the school system. The cost analysis will include different component of the implementation strategy, such as designing and improving the training program, conducting the training and the associated activities, participating adolescents' self-reported psychological well-being pre- and post-intervention, and their continued efficacy in providing digital peer support three and six months post-intervention. Immediately after the training program/last session of the training workshop
Secondary Psychological well-being Adolescents' psychological well-being will be assessed using the 18-item Ryff's psychological well-being measure (Ryff & Keyes, 1995) on a 6-point scale that ranges from 1 (strongly disagree) to 6 (strongly agree). The measure consists of six dimensions, including positive relations with others, autonomy, environment mastery, personal growth, purpose in life, and self-acceptance. Immediately after the training program/last session of the training workshop
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