A Study Protocol on Peer Digital Acceset (PDA)

Mental Health Issue Clinical Trial

— PDA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05083676
• Other study ID #: Acceset Prospective Study
• Status: Completed
• Phase: N/A
• Start date: January 31, 2022
• Est. completion date: February 2, 2023

Study information

• Verified date: February 2023
• Source: The N.1 Institute for Health (N.1)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2, 2023
• Est. primary completion date: February 2, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mental Health Issue

Intervention

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.

Locations

Country	Name	City	State
Singapore	N.1 Institute for Health	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
The N.1 Institute for Health (N.1)	Acceset

Country where clinical trial is conducted

Singapore, 

References & Publications (56)

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* Note: There are 56 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)