A Study Protocol on Peer Digital Acceset (PDA) (PDA)

A Study Protocol on Peer Digital Acceset (PDA): A Randomized Controlled Trial to Translate Online Peer Support for Youth Mental Well-being

This protocol delineates a randomized controlled trial for evaluating the implementation and clinical effectiveness of Assecet, a digital peer support intervention for youth mental well-being, which comprises two components. The digital peer support training curriculum aims to equip youth befrienders (i.e., peers who provide support) with knowledge and skills in harnessing four active ingredients of youth mental well-being-specifically, Mattering, selfhood, compassion, and mindfulness, in providing effective peer support for seekers (peers who seek support). The Acceset intervention that involves three components-digital biomarkers of psychological well-being, peer emotional disclosure process and community engagement.

Study Overview

• Status: Completed
• Conditions: Mental Health Issue
• Intervention / Treatment: Behavioral: Acceset Intervention

Detailed Description

Background: The burgeoning mental health issues among emerging adults (ages 19 to 25) worldwide has fuelled concerns about youths' widespread experiences of emotional distress, specifically concerning anxiety and depression, and coping mechanisms. Digital peer support intervention has demonstrated varying degrees of clinical effectiveness for positive health and psychological outcomes across different developmental stages. The onset of the COVID-19 pandemic has resulted in prolonged isolation and reduced social connections, and emerging literature is amounting to the import of digital peer emotional disclosure and support for young people psychological well-being. However, much remains to be explored regarding implementation and clinical effectiveness-how best to conduct digital peer intervention in support of youths' psychological well-being, and the associated mechanism of change.

Objective: This protocol delineates a randomized controlled trial for evaluating the implementation and clinical effectiveness of Assecet, a digital peer support intervention for youth mental well-being, which comprises two components. The digital peer support training curriculum aims to equip youth befrienders (i.e., peers who provide support) with knowledge and skills in harnessing four active ingredients of youth mental well-being-specifically, Mattering, selfhood, compassion, and mindfulness, in providing effective peer support for seekers (peers who seek support). The Acceset intervention that involves three components-digital biomarkers of psychological well-being, peer emotional disclosure process and community engagement.

Methods: Participants will consist of 100 students ages 19 to 25 from the National University of Singapore to engage with the Acceset platform. At the time of recruitment, individuals will be screened for inclusion and exclusion criteria based on self-reporting. The qualified participants (seekers) will be randomly allocated into two arms. Arm 1 (n = 50) seekers will engage with the Acceset platform for a period of 3 weeks, together with befrienders (n = 30) and moderators (n = 30). Arm 2 (n = 50) a control group will be placed on a waitlist for Acceset intervention. These individuals will be age and gender matched with the intervention group (i.e., arm 1). Their mental well-being, as well as their help seeking behavior, at the same time points and via the same questionnaire battery will be compared with those in arm 1. Both seekers and befrienders will be monitored using a questionnaire battery listed (including help seeking behaviors beyond the Acceset platform) at 4 time points: baseline (before the intervention), 3 weeks (the end of the intervention), 6 weeks and 9 weeks (to measure carry over effects). The implementation outcomes will be adoption and fidelity evaluation of the digital peer support training curriculum, the feasibility and acceptability of Acceset in providing continuous access to online peer support throughout the duration of the seekers' engagement. The clinical outcomes will include Mattering, self-hood, compassion, mindfulness, psychological well-being scores for befrienders and seekers, and additionally perceived social support for seekers. The mechanism of change linking befrienders' support and seekers' mental well-being will be assessed using latent growth curve modelling.

Data Collection, Management and Analyses: We conducted power analysis to ascertain the adequate sample size needed for the randomized controlled trial, specifically in comparing the intervention and control groups on different 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 clinical outcomes included in the study and the testing of implementation outcomes (i.e., feasibility, utility). In dealing with missing data, we will first determine if missing data is missing completely at random (MCAR). If missing data is not systematic, as indicated by the non-significant result from Little's Missing Completely at Random Test, this study will handle missing data using full information maximum likelihood imputation.

Data will be analyzed and interpreted through three means. First, independent sample t-tests will be conducted whenever we need to compare intervention vs. control group on the different clinical outcomes in this study. Second, to elucidate the content of emotional disclosure on the Acceset platform, particularly in relation to the four active ingredients of psychological well-being (i.e., Mattering, self-hood, compassion and mindfulness), we will perform 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 as compared to the exclusive use of qualitative approach /analyses. Third, to compare the mechanism of change , we will use Latent Growth Curve Modelling (LCM) to examine the trajectories of Acceset intervention in predicting the change in clinical outcomes experienced by youths. LCM elucidates whether an increasing trend in befrienders' digital peer support predicts increasing trends in youths' sense of Mattering, self-hood, compassion, mindfulness, and psychological well-being (i.e., clinical outcomes).

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 117456
    • N.1 Institute for Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 25 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• youths aged 19 to 25 selective (distressed but healthy)
• primary indicative (exhibiting some symptoms but can't formally diagnose for anxiety, /depression or mental health disorder).

Exclusion Criteria:

--youths with high risk for suicidality detected at the time of screening with a validated psychological scale-PHQ-9.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acceset Intervention; The qualified participants (seekers) will be randomly allocated into two arms. Arm 1 (n = 50) seekers will engage with the Acceset platform for a period of 3 weeks, together with befrienders (n = 30) and moderators (n = 30). Both seekers and befrienders will be monitored using a questionnaire battery listed (including help seeking behaviors beyond the Acceset platform) at 4 time points: baseline (before the intervention), 3 weeks (the end of the intervention), 6 weeks and 9 weeks (to measure carry over effects).	Behavioral: Acceset Intervention; . The intervention comprises of: i) Digital peer support training for youth befrienders to equip them with the knowledge and application of the four active ingredients-Mattering, selfhood, compassion, and mindfulness-to provide effective peer support as they respond to youth seekers' emotional experiences. ii) Acceset Intervention with features or digital markers of psychological well-being, peer emotional disclosure process and community engagement.; Other Names: Digital Peer Support Intervention
Active Comparator: waitlist for Acceset intervention; Arm 2 (n = 50) a control group will be placed on a waitlist for Acceset intervention. These individuals will be age and gender matched with the intervention group (i.e., arm 1). Their mental well-being, as well as their help seeking behavior, at the same time points and via the same questionnaire battery will be compared with those in arm 1.	Behavioral: Acceset Intervention; . The intervention comprises of: i) Digital peer support training for youth befrienders to equip them with the knowledge and application of the four active ingredients-Mattering, selfhood, compassion, and mindfulness-to provide effective peer support as they respond to youth seekers' emotional experiences. ii) Acceset Intervention with features or digital markers of psychological well-being, peer emotional disclosure process and community engagement.; Other Names: Digital Peer Support Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in anxiety scores across 4 time points (seekers, befrienders): baseline (before the intervention), 3 weeks (the end of the intervention), 6 weeks and 9 weeks (to measure carry over effects)	Anxiety; 7-item General Anxiety Disorder Questionnaire; Self-reported measure; score range: 0 to 3, with higher score indicating greater anxiety severity Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Archives of internal medicine 2006 May 22;166(10):1092-7.	baseline (before the intervention), 3 weeks (the end of the intervention), 6 weeks and 9 weeks (to measure carry over effects)
Change in depression scores across 4 time points (seekers, befrienders): baseline (before the intervention), 3 weeks (the end of the intervention), 6 weeks and 9 weeks (to measure carry over effects)	Depression; 9-item Patient Health Questionnaire; Self-reported measure; score range: 0 to 3, with higher scores reflecting greater depression severity Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. Journal of General Internal Medicine 2001 Sep; 16(9):606-13. [doi: 10.1046/j.1525-1497.2001.016009606.x]	baseline (before the intervention), 3 weeks (the end of the intervention), 6 weeks and 9 weeks (to measure carry over effects)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Active ingredients of youth mental well-being (befrienders)--Mattering	Content or qualitative analysis of befrienders' responses using the Rosenberg Mattering scale; score range: 1 to 4, with higher score indicating greater sense of mattering. Rosenberg, M., & McCullough, B. C. (1981). Mattering: Inferred significance and mental health among adolescents. Research in Community & Mental Health, 2, 163-182.	Immediately before the start of digital peer support training and right after the training ends
Active ingredients of youth mental well-being (befrienders)--self-hood,	Content or qualitative analysis of befrienders' responses using three sub-scales on Self-knowledge: the internal self in you that reflects on things on hindsight Interpersonal self: how our self evolves based on who we are with Self as agent: the self that you build up based on the choices you make to achieve a future target score range: 1 to 4, with higher score indicating stronger self-hood Baumeister, R. F. (2010). The self. In R. F. Baumeister & E. J. Finkel (Eds.), Advanced social psychology: The state of the science (pp. 139-175). Oxford University Press.)	Immediately before the start of digital peer support training and right after the training ends
Active ingredients of youth mental well-being (befrienders)--compassion	Content or qualitative analysis of befrienders' responses using the Fears of Compassion Scales. Score range: 0 to 4, lower scores indicate greater compassion (i.e., decreased fear of compassion). Self-Compassion Scale (SCS; Neff 2003). score range: 1 to 5, with higher score indicating higher compassion Gilbert, P., McEwan, K., Matos, M., & Rivis, A. (2010). Fears of compassion: Development of three selfreport measures. Psychology and Psycotherapy: Theory, Research and Practice. doi: 10.1348/147608310X526511. Neff, K. D. (2003). The development and validation of a scale to measure self-compassion. Self and Identity, 2, 223-250. doi:10.1080/15298860309027.	Immediately before the start of digital peer support training and right after the training ends
Active ingredients of youth mental well-being (befrienders)--mindfulness	Content or qualitative analysis of befrienders' responses using the mindfulness subscale from the Self-Compassion Scale (SCS; Neff 2003a). score range: 1 to 5, with higher score indicating higher mindfulness Neff, K. D. (2003). The development and validation of a scale to measure self-compassion. Self and Identity, 2, 223-250. doi:10.1080/15298860309027.	Immediately before the start of digital peer support training and right after the training ends
Change in College adjustment scores across 4 time points (seekers, befrienders): baseline (before the intervention), 3 weeks (the end of the intervention), 6 weeks and 9 weeks (to measure carry over effects)	Student Adaptation to College Questionnaire; Self-reported measure; score range: 1 to 9, with higher score indicating better adjustment. Baker RW, Siryk B. Measuring adjustment to college. Journal of counseling psychology 1984 Apr;31(2):179.	baseline (before the intervention), 3 weeks (the end of the intervention), 6 weeks and 9 weeks (to measure carry over effects)
Change in perceived social support across 4 time points (seekers): baseline (before the intervention), 3 weeks (the end of the intervention), 6 weeks and 9 weeks (to measure carry over effects)	Multidimensional Scale of Perceived Social Support (MSPSS); Self-reported measure; score range: 1 to 7, with higher score indicating greater perceived social support. Zimet GD Dahlem N Zimet SG Farley GK 1994 The Multidimensional Scale of Perceived Social Support (MSPSS) In J. F.Kevin (Ed.) The measures for clinical practice: A sourcebook Vol 2 Adults(2nd ed.) New York The Free Press	baseline (before the intervention), 3 weeks (the end of the intervention), 6 weeks and 9 weeks (to measure carry over effects)
Change in Mattering scores across 4 time points (seekers, befrienders): baseline (before the intervention), 3 weeks (the end of the intervention), 6 weeks and 9 weeks (to measure carry over effects)	Rosenberg Mattering scale; Self-reported measure; score range: 1 to 4, with higher score indicating greater sense of mattering. Rosenberg, M., & McCullough, B. C. (1981). Mattering: Inferred significance and mental health among adolescents. Research in Community & Mental Health, 2, 163-182.	baseline (before the intervention), 3 weeks (the end of the intervention), 6 weeks and 9 weeks (to measure carry over effects)
Client Satisfaction (seekers)	Client Satisfaction Questionnaire (CSQ-8); Self-reported measure, score range: 1 to 4, with higher score indicating greater satisfaction Attkisson, C. C., & Greenfield, T. K. (2004). The UCSF Client Satisfaction Scales: I. The Client Satisfaction Questionnaire-8. In M. E. Maruish (Ed.), The use of psychological testing for treatment planning and outcomes assessment: Instruments for adults (pp. 799-811). Lawrence Erlbaum Associates Publishers.	3 weeks (the end of the intervention)
Client Satisfaction (befriender; digital peer support training program)	Client Satisfaction Questionnaire (CSQ-8); Self-reported measure, score range: 1 to 4, with higher score indicating greater satisfaction Attkisson, C. C., & Greenfield, T. K. (2004). The UCSF Client Satisfaction Scales: I. The Client Satisfaction Questionnaire-8. In M. E. Maruish (Ed.), The use of psychological testing for treatment planning and outcomes assessment: Instruments for adults (pp. 799-811). Lawrence Erlbaum Associates Publishers.	immediately after digital peer support training workshop
Focus group interview to assess barriers and facilitators of implementation and clinical effectiveness (befrienders, moderators)	i. In assessing IMPLEMENTATION outcomes (i.e., whether Acceset intervention is feasible and acceptable), we will discuss with befrienders and moderators the following: 1. Whether Acceset acts as a timely intervention i.e., in supporting youth seekers when they needed peer support? 2. Whether using Acceset is acceptable and satisfactory in terms of befrienders' attitudes towards the use of Acceset as an intervention (e.g., "I found Acceset easy to use")? ii. In assessing CLINICAL outcomes (i.e., whether Acceset improves or impacts positively the mental health outcomes), we will discuss with befrienders and moderators the following: Meaningful Aspect of Health: Whether and how Acceset supports youth seekers in their emotion management.; Concept of Interest: Whether and how Acceset practically measures specific elements of emotion management using the emotion sticker pack.; Endpoints: Whether and how Acceset captures precisely data that reflects outcomes of interest.	3 weeks (the end of the intervention)
Change in Giving social support scores across 4 time points (befrienders): baseline (before the intervention), 3 weeks (the end of the intervention), 6 weeks and 9 weeks (to measure carry over effects).	Giving instrumental support to others (GISO); Self-reported measure, score range: Yes or No, with more Yes indicating a greater extent of giving instrumental support. Brown SL, Nesse RM, Vinokur AD, Smith DM. Providing social support may be more beneficial than receiving it: Results from a prospective study of mortality. Psychological Science 2003 Jul;14(4):320-7.	baseline (before the intervention), 3 weeks (the end of the intervention), 6 weeks and 9 weeks (to measure carry over effects)
Burnout (befrienders)	Oldenburg Burnout Inventory; Self-reported measure, score range: 1 to 4, with higher score indicating greater extent of burnout. Demerouti E, Mostert K, Bakker AB. Burnout and work engagement: a thorough investigation of the independency of both constructs. Journal of Occupational Health Psychology 2010 Jul;15(3):209.	3 weeks (the end of the intervention)

Collaborators and Investigators

• Sponsor: The N.1 Institute for Health (N.1)
• Collaborators: Acceset
• Investigators: Principal Investigator: Dean Ho, PhD, N.1 Institute for Health, National University of Singapore; Study Director: GeckHong Yeo, PhD, N.1 Institute for Health, National University of Singapore

Publications and helpful links

General Publications

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• Levesque, R. J. R. (2011). Externalizing and internalizing symptoms. In R. J. R Levesque (Eds.), Encyclopedia of Adolescence (pp. 903-905). Springer Science & Business Media
• Yeo G, Chang W, Lee LN, Oon M, Ho D. A Digital Peer Support Platform to Translate Web-Based Peer Support for Emerging Adult Mental Well-being: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Sep 20;11(9):e34602. doi: 10.2196/34602.

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2022
• Primary Completion (Actual): February 2, 2023
• Study Completion (Actual): February 2, 2023

Study Registration Dates

• First Submitted: September 15, 2021
• First Submitted That Met QC Criteria: October 18, 2021
• First Posted (Actual): October 19, 2021

Study Record Updates

• Last Update Posted (Actual): March 2, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Mindfulness; community; Compassion; Digital biomarkers; Mental Well-being; Mattering; Self-hood; Digital Peer Support Intervention; peer emotional disclosure
• Other Study ID Numbers: Acceset Prospective Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in article publication, after deidentification (text, tables, figures, and appendices)
• IPD Sharing Time Frame: Beginning 12 months and ending 36 months following article publication
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No