Adolescent DevelopmentNCT05199675
Implementing Digital Peer Support Training for Adolescent Mental Health
A study testing Digital Peer Support Training Program in people with Adolescent Development and Peer Group, run by The N.1 Institute for Health (N.1).
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… Read more about this study
- Who is it for?
- Ages 13 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Development, Peer Group, Mental Health Wellness 1
- What is being tested?
- Digital Peer Support Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2022to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Implementing Digital Peer Support Training for Adolescent Mental Health: Study Protocol For A Type III Hybrid Randomized Controlled Trial
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?
Read the 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.
- Conditions
- Adolescent Development, Peer Group, Mental Health Wellness 1
- Being tested
- Digital Peer Support Training Program
- Keywords
- Hybrid III trial,, Adolescence, Digital peer support, Mental Health, Implementation Science, Communication Science, Developmental psychology
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Peer Support Training ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Digital Peer Support Training Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Before and immediately after training (as pre-class activity and homework assignment, respectively)
Secondary outcomes (5)
Reach
The number of adolescents who received the training divided by the number of eligible adolescents from the four classes (clusters), will be established.
Measured: Immediately after the training program/last session of the training workshop
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).
Measured: Immediately after the training program/last session of the training workshop
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
Measured: Immediately after the training program/last session of the training workshop
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.
Measured: Immediately after the training program/last session of the training workshop
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.
Measured: Immediately after the training program/last session of the training workshop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start31 Jan 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (50)Papers the sponsor has linked to this study.
- Other trials for Adolescent DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The N.1 Institute for Health (N.1)
- Sponsor type
- University, hospital or other
- Collaborators
- Manjusri Secondary School, Singapore
- Responsible party
- Sponsor
- Investigators
- GeckHong Yeo, PhD, Principal investigator, N.1 Institute for Health, National University of SingaporeDean Ho, PhD, Principal investigator, N.1 Institute for Health, National University of SingaporeWei Ning Chang, PhD, Principal investigator, Institute of Mental Health, SingaporeBradford Brown, PhD, Principal investigator, University of Wiscosnsin, Madison; Department of Educational Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05199675
- Sponsor's protocol ID
- NUS-IRB-2021-761
- Status last verified
- Jan 2022
- First submitted
- 15 Dec 2021
- Last updated
- 20 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in article publication, after deidentification (text, tables, figures, and appendices)
Publications
Kieling C, Baker-Henningham H, Belfer M, Conti G, Ertem I, Omigbodun O, Rohde LA, Srinath S, Ulkuer N, Rahman A. Child and adolescent mental health worldwide: evidence for action. Lancet. 2011 Oct 22;378(9801):1515-25. doi: 10.1016/S0140-6736(11)60827-1. Epub 2011 Oct 16.
PubMed 22008427Larson RW, Moneta G, Richards MH, Wilson S. Continuity, stability, and change in daily emotional experience across adolescence. Child Dev. 2002 Jul-Aug;73(4):1151-65. doi: 10.1111/1467-8624.00464.
PubMed 12146740Marques de Miranda D, da Silva Athanasio B, Sena Oliveira AC, Simoes-E-Silva AC. How is COVID-19 pandemic impacting mental health of children and adolescents? Int J Disaster Risk Reduct. 2020 Dec;51:101845. doi: 10.1016/j.ijdrr.2020.101845. Epub 2020 Sep 10.
PubMed 32929399Nearchou F, Flinn C, Niland R, Subramaniam SS, Hennessy E. Exploring the Impact of COVID-19 on Mental Health Outcomes in Children and Adolescents: A Systematic Review. Int J Environ Res Public Health. 2020 Nov 16;17(22):8479. doi: 10.3390/ijerph17228479.
PubMed 33207689Prinstein, M. J., & Giletta, M. (2016). Peer relations and developmental psychopathology. In D. Cicchetti (Ed.), developmental psychopathology (pp. 1-53). Hoboken, NJ: Wiley. https ://doi.org/10.1002/97811 19125 556.devps y112.
Choukas-Bradley, S., & Prinstein, M. J. (2014). Peer relationships and the development of psychopathology. In M. Lewis & K. D. Rudolph (Eds.), Handbook of developmental psychopathology (pp. 185-204). Boston, MA: Springer
Parker, J. (2006). Peer relationships, child development, and adjustment: A developmental psychopathology perspective. Developmental Psychopathology, Theory and Method, 1, 419. https://doi.org/10.1002/97804 70939 383.ch12.
Valkenburg, P. M., & Peter, J. (2009). The effects of instant messaging on the quality of adolescents' existing friendships: A longitudinal study. Journal of Communication, 59, 79-97. http://dx.doi.org/10.1111/j.1460-2466.2008.01405.x
Valkenburg PM, Peter J. Online communication among adolescents: an integrated model of its attraction, opportunities, and risks. J Adolesc Health. 2011 Feb;48(2):121-7. doi: 10.1016/j.jadohealth.2010.08.020. Epub 2010 Dec 13.
PubMed 21257109Choi, M., & Toma, C. L. (2014). Social sharing through interpersonal media: Patterns and effects on emotional well-being. Computers in Human Behavior, 36, 530-541. http://dx.doi.org/10.1016/j.chb.2014.04.026
Huckins JF, daSilva AW, Wang W, Hedlund E, Rogers C, Nepal SK, Wu J, Obuchi M, Murphy EI, Meyer ML, Wagner DD, Holtzheimer PE, Campbell AT. Mental Health and Behavior of College Students During the Early Phases of the COVID-19 Pandemic: Longitudinal Smartphone and Ecological Momentary Assessment Study. J Med Internet Res. 2020 Jun 17;22(6):e20185. doi: 10.2196/20185.
PubMed 32519963Loades ME, Chatburn E, Higson-Sweeney N, Reynolds S, Shafran R, Brigden A, Linney C, McManus MN, Borwick C, Crawley E. Rapid Systematic Review: The Impact of Social Isolation and Loneliness on the Mental Health of Children and Adolescents in the Context of COVID-19. J Am Acad Child Adolesc Psychiatry. 2020 Nov;59(11):1218-1239.e3. doi: 10.1016/j.jaac.2020.05.009. Epub 2020 Jun 3.
PubMed 32504808Lippke S, Fischer MA, Ratz T. Physical Activity, Loneliness, and Meaning of Friendship in Young Individuals - A Mixed-Methods Investigation Prior to and During the COVID-19 Pandemic With Three Cross-Sectional Studies. Front Psychol. 2021 Feb 2;12:617267. doi: 10.3389/fpsyg.2021.617267. eCollection 2021.
PubMed 33603702Nesi J, Choukas-Bradley S, Prinstein MJ. Transformation of Adolescent Peer Relations in the Social Media Context: Part 1-A Theoretical Framework and Application to Dyadic Peer Relationships. Clin Child Fam Psychol Rev. 2018 Sep;21(3):267-294. doi: 10.1007/s10567-018-0261-x.
PubMed 29627907Fortuna KL, Venegas M, Umucu E, Mois G, Walker R, Brooks JM. The Future of Peer Support in Digital Psychiatry: Promise, Progress, and Opportunities. Curr Treat Options Psychiatry. 2019 Sep;6(3):221-231. doi: 10.1007/s40501-019-00179-7. Epub 2019 Jun 20.
PubMed 33796435
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Digital Peer Support Training for Adolescent Mental Health: Study Protocol For A Type III Hybrid Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05199675
- Acronym / sponsor ID
- NUS-IRB-2021-761
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The N.1 Institute for Health (N.1)University, hospital or other
- Collaborators
- Manjusri Secondary School, Singapore
- Study start
- 31 Jan 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 20 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Digital Peer Support Training Program | Experimental | Behavioral: Digital Peer Support Training ProgramThe 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. |
| Waitlist control for Digital Peer Support Training Program | Active comparator | Behavioral: Digital Peer Support Training ProgramStudents 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. |
Who may qualify
- Ages
- 13 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Peer Support Training ProgramThe 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. | Behavioural | Digital Peer Support Training Program, Waitlist control for Digital Peer Support Training Program |
Primary outcome
Change in Fidelity--Mattering
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
5 secondary outcomes
Reach
Time frame: Immediately after the training program/last session of the training workshop
Acceptability--Self-report
Time frame: Immediately after the training program/last session of the training workshop
Acceptability--focus group discussions
Time frame: Immediately after the training program/last session of the training workshop
Cost-effectiveness
Time frame: Immediately after the training program/last session of the training workshop
Psychological well-being
Time frame: Immediately after the training program/last session of the training workshop
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2022.
- Background: PubMed 22008427Kieling C, Baker-Henningham H, Belfer M, Conti G, Ertem I, Omigbodun O, Rohde LA, Srinath S, Ulkuer N, Rahman A. Child and adolescent mental health worldwide: evidence for action. Lancet. 2011 Oct 22;378(9801):1515-25. doi: 10.1016/S0140-6736(11)60827-1. Epub 2011 Oct 16.
- Background: PubMed 12146740Larson RW, Moneta G, Richards MH, Wilson S. Continuity, stability, and change in daily emotional experience across adolescence. Child Dev. 2002 Jul-Aug;73(4):1151-65. doi: 10.1111/1467-8624.00464.
- Background: PubMed 32929399Marques de Miranda D, da Silva Athanasio B, Sena Oliveira AC, Simoes-E-Silva AC. How is COVID-19 pandemic impacting mental health of children and adolescents? Int J Disaster Risk Reduct. 2020 Dec;51:101845. doi: 10.1016/j.ijdrr.2020.101845. Epub 2020 Sep 10.
- Background: PubMed 33207689Nearchou F, Flinn C, Niland R, Subramaniam SS, Hennessy E. Exploring the Impact of COVID-19 on Mental Health Outcomes in Children and Adolescents: A Systematic Review. Int J Environ Res Public Health. 2020 Nov 16;17(22):8479. doi: 10.3390/ijerph17228479.
- BackgroundPrinstein, M. J., & Giletta, M. (2016). Peer relations and developmental psychopathology. In D. Cicchetti (Ed.), developmental psychopathology (pp. 1-53). Hoboken, NJ: Wiley. https ://doi.org/10.1002/97811 19125 556.devps y112.
- BackgroundChoukas-Bradley, S., & Prinstein, M. J. (2014). Peer relationships and the development of psychopathology. In M. Lewis & K. D. Rudolph (Eds.), Handbook of developmental psychopathology (pp. 185-204). Boston, MA: Springer
- BackgroundParker, J. (2006). Peer relationships, child development, and adjustment: A developmental psychopathology perspective. Developmental Psychopathology, Theory and Method, 1, 419. https://doi.org/10.1002/97804 70939 383.ch12.
- BackgroundValkenburg, P. M., & Peter, J. (2009). The effects of instant messaging on the quality of adolescents' existing friendships: A longitudinal study. Journal of Communication, 59, 79-97. http://dx.doi.org/10.1111/j.1460-2466.2008.01405.x
- Background: PubMed 21257109Valkenburg PM, Peter J. Online communication among adolescents: an integrated model of its attraction, opportunities, and risks. J Adolesc Health. 2011 Feb;48(2):121-7. doi: 10.1016/j.jadohealth.2010.08.020. Epub 2010 Dec 13.
- BackgroundChoi, M., & Toma, C. L. (2014). Social sharing through interpersonal media: Patterns and effects on emotional well-being. Computers in Human Behavior, 36, 530-541. http://dx.doi.org/10.1016/j.chb.2014.04.026
- Background: PubMed 32519963Huckins JF, daSilva AW, Wang W, Hedlund E, Rogers C, Nepal SK, Wu J, Obuchi M, Murphy EI, Meyer ML, Wagner DD, Holtzheimer PE, Campbell AT. Mental Health and Behavior of College Students During the Early Phases of the COVID-19 Pandemic: Longitudinal Smartphone and Ecological Momentary Assessment Study. J Med Internet Res. 2020 Jun 17;22(6):e20185. doi: 10.2196/20185.
- Background: PubMed 32504808Loades ME, Chatburn E, Higson-Sweeney N, Reynolds S, Shafran R, Brigden A, Linney C, McManus MN, Borwick C, Crawley E. Rapid Systematic Review: The Impact of Social Isolation and Loneliness on the Mental Health of Children and Adolescents in the Context of COVID-19. J Am Acad Child Adolesc Psychiatry. 2020 Nov;59(11):1218-1239.e3. doi: 10.1016/j.jaac.2020.05.009. Epub 2020 Jun 3.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in article publication, after deidentification (text, tables, figures, and appendices)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GeckHong Yeo, PhD principal investigator
N.1 Institute for Health, National University of Singapore
Dean Ho, PhD principal investigator
N.1 Institute for Health, National University of Singapore
Wei Ning Chang, PhD principal investigator
Institute of Mental Health, Singapore
Questions about this trial
What is this clinical trial studying?
A study testing Digital Peer Support Training Program in people with Adolescent Development and Peer Group, run by The N.1 Institute for Health (N.1).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact GeckHong Yeo, PhD (66017766, LSIGHY@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fidelity--Mattering (time frame: Before and immediately after training (as pre-class activity and homework assignment, respectively)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05199675, which also lists 50 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2022.