Mental Health Wellness 1 Clinical Trial
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?
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
The N.1 Institute for Health (N.1) | Manjusri Secondary School, Singapore |
Albers B, Shlonsky A, Mildon R, editors. Implementation Science 3.0. Springer Nature; 2020 Mar 18.
Albers, B., Mildon, R., Lyon, A. R., & Shlonsky, A. (2017). Implementation frameworks in child, youth and family services-Results from a scoping review. Children and Youth Services Review, 81, 101-116. https://doi.org/10.1016/j.childyouth.2017.07.003
Ali K, Farrer L, Gulliver A, Griffiths KM. Online Peer-to-Peer Support for Young People With Mental Health Problems: A Systematic Review. JMIR Ment Health. 2015 May 19;2(2):e19. doi: 10.2196/mental.4418. eCollection 2015 Apr-Jun. Review. — View Citation
Attkisson, C. C., & Greenfield, T. K. (1994). Client Satisfaction Questionnaire-8 and Service Satisfaction Scale-30. In M. E. Maruish (Ed.), The use of psychological testing for treatment planning and outcome assessment (pp. 402-420). Lawrence Erlbaum Associates, Inc.
Baumeister RF. The self. In Finkel EJ, Baumeister RF, editors. Advanced social psychology: the state of the science. New York: Oxford University Press; 2016. p. 89-116. ISBN: 9780195381207
Butzer, B., & Kuiper, N. A. (2006). Relationships between the frequency of social comparisons and self-concept clarity, intolerance of uncertainty, anxiety, and depression. Personality and Individual Differences 41(1), 167-176. https ://doi.org/10.1016/j.paid.2005.12.017.
Carson SH, Langer EJ. Mindfulness and self-acceptance. Journal of rational-emotive and cognitive-behavior therapy. 2006; 24(1):29-43.
Choi, 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
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
Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812. — View Citation
Elliott G, Kao S, Grant AM. Mattering: empirical validation of a social-psychological concept. Self and Identity 2004 Oct 1; 3(4):339-54. [doi: 10.1080/13576500444000119]
Finding the next generation of mental health treatments and approaches. Wellcome.org. URL: https://wellcome.org/news/finding-next-generation-mental-health-treatments-and-approaches [access 2021-11-01]
Flett GL, Nepon T. Mattering versus self-esteem in university students: associations with regulatory focus, social feedback, and psychological distress. Journal of Psychoeducational Assessment 2020 Sep; 38(6):663-74. [doi: 10.1177/0734282919890786]
Fortuna 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. — View Citation
Gillard S. Peer support in mental health services: where is the research taking us, and do we want to go there? J Ment Health. 2019 Aug;28(4):341-344. doi: 10.1080/09638237.2019.1608935. Epub 2019 May 9. — View Citation
Hart LM, Morgan AJ, Rossetto A, Kelly CM, Mackinnon A, Jorm AF. Helping adolescents to better support their peers with a mental health problem: A cluster-randomised crossover trial of teen Mental Health First Aid. Aust N Z J Psychiatry. 2018 Jul;52(7):638-651. doi: 10.1177/0004867417753552. Epub 2018 Feb 8. — View Citation
Huang J, Nigatu YT, Smail-Crevier R, Zhang X, Wang J. Interventions for common mental health problems among university and college students: A systematic review and meta-analysis of randomized controlled trials. J Psychiatr Res. 2018 Dec;107:1-10. doi: 10.1016/j.jpsychires.2018.09.018. Epub 2018 Sep 29. — View Citation
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. — View Citation
Jazaieri H, Jinpa GT, McGonigal K, Rosenberg EL, Finkelstein J, Simon-Thomas E, Cullen M, Doty JR, Gross JJ, Goldin PR. Enhancing compassion: A randomized controlled trial of a compassion cultivation training program. Journal of Happiness Studies. 2013 Aug;14(4):1113-26. https://doi.org/10.1007/s10902-012-9373-z
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. Review. — View Citation
Kirby JN, Tellegen CL, Steindl SR. A Meta-Analysis of Compassion-Based Interventions: Current State of Knowledge and Future Directions. Behav Ther. 2017 Nov;48(6):778-792. doi: 10.1016/j.beth.2017.06.003. Epub 2017 Jun 21. Review. — View Citation
Larson 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. — View Citation
Lippke 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. — View Citation
Loades 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. — View Citation
Ma X, Tamir M, Miyamoto Y. A socio-cultural instrumental approach to emotion regulation: Culture and the regulation of positive emotions. Emotion. 2018 Feb;18(1):138-152. doi: 10.1037/emo0000315. Epub 2017 Apr 17. — View Citation
Marques 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. Review. — View Citation
Marshall SK, Tilton-Weaver L. Adolescents' perceived mattering to parents and friends: testing cross-lagged associations with psychosocial well-being. International Journal of Behavioral Development 2019 Nov; 43(6):541-52. [doi: 10.1177/0165025419844019]
Marshall SK. Do I matter? Construct validation of adolescents' perceived mattering to parents and friends. J Adolesc. 2001 Aug;24(4):473-90. — View Citation
Marshall SK. Relative contributions of perceived mattering to parents and friends in predicting adolescents' psychological well-being. Percept Mot Skills. 2004 Oct;99(2):591-601. — View Citation
Miyamoto Y, Uchida Y, Ellsworth PC. Culture and mixed emotions: co-occurrence of positive and negative emotions in Japan and the United States. Emotion. 2010 Jun;10(3):404-15. doi: 10.1037/a0018430. — View Citation
Moir F, Henning M, Hassed C, Moyes SA, Elley CR. A Peer-Support and Mindfulness Program to Improve the Mental Health of Medical Students. Teach Learn Med. 2016 Jul-Sep;28(3):293-302. doi: 10.1080/10401334.2016.1153475. Epub 2016 Apr 19. — View Citation
Nearchou 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). pii: E8479. doi: 10.3390/ijerph17228479. — View Citation
Nesi 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. Review. — View Citation
Nixon CL. Current perspectives: the impact of cyberbullying on adolescent health. Adolesc Health Med Ther. 2014 Aug 1;5:143-58. doi: 10.2147/AHMT.S36456. eCollection 2014. Review. — View Citation
Oberle E, Schonert-Reichl KA, Thomson KC. Understanding the link between social and emotional well-being and peer relations in early adolescence: gender-specific predictors of peer acceptance. J Youth Adolesc. 2010 Nov;39(11):1330-42. doi: 10.1007/s10964-009-9486-9. Epub 2009 Nov 29. — View Citation
Odgers CL, Jensen MR. Annual Research Review: Adolescent mental health in the digital age: facts, fears, and future directions. J Child Psychol Psychiatry. 2020 Mar;61(3):336-348. doi: 10.1111/jcpp.13190. Epub 2020 Jan 17. Review. — View Citation
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.
Pavarini, G., Reardon, T., Hollowell, A., Bennett, V., Lawrance, E., Pinfold, V., & Singh, I. (2021). Online peer support training to promote adolescents' emotional support skills, mental health and agency during COVID-19: A pilot randomised controlled trial. Preprint
Prinstein, 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.
QSR International. (2012). NVivo 10 [Computer software]. Retrieved from http://www.qsrinternational.com
Ramchand R, Ahluwalia SC, Xenakis L, Apaydin E, Raaen L, Grimm G. A systematic review of peer-supported interventions for health promotion and disease prevention. Prev Med. 2017 Aug;101:156-170. doi: 10.1016/j.ypmed.2017.06.008. Epub 2017 Jun 8. Review. — View Citation
Richardson, G. M., Bowers, J., Woodill, A. J., Barr, J. R., Gawron, J. M., & Levine, R. A. (2014). Topic models: A tutorial with R. International Journal of Semantic Computing, 8, 85-98. https://doi.org/10.1142/S1793351X14500044
Rosenberg, M. (1989). Society and the adolescent self-image. Middleton, CT: Wesleyan University Press.
Rosenberg, M., & McCullough, B. C. (1981). Mattering: Inferred significance and mental health among adolescents. Research in Community & Mental Health, 2, 163-182.
Ryff CD, Keyes CL. The structure of psychological well-being revisited. J Pers Soc Psychol. 1995 Oct;69(4):719-27. — View Citation
Tolley JA, Michel MA, Williams AE, Renschler JS. Peer Support in the Treatment of Chronic Pain in Adolescents: A Review of the Literature and Available Resources. Children (Basel). 2020 Sep 7;7(9). pii: E129. doi: 10.3390/children7090129. Review. — View Citation
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. Review. — View Citation
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
Van Gordon W, Shonin E, Griffiths MD. Towards a second generation of mindfulness-based interventions. Aust N Z J Psychiatry. 2015 Jul;49(7):591-2. doi: 10.1177/0004867415577437. Epub 2015 Mar 23. — View Citation
Wandersman, A., Imm, P., Chinman, M., & Kaftarian, S. (2000). Getting to outcomes: A results-based approach to accountability. Evaluation and program planning, 23(3), 389-395. https://doi.org/10.1016/S0149-7189(00)00028-8
* Note: There are 50 references in all — Click here to view all references
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05130944 -
Feasibility of Community Psychosocial Intervention for Women
|
N/A | |
Recruiting |
NCT06079853 -
Nurse Suicide: Physiologic Sleep Health Promotion Trial
|
N/A | |
Completed |
NCT05490979 -
The Impact of Dyad Exercises on Well-being and Connection in Young Adults
|
N/A | |
Not yet recruiting |
NCT05963893 -
Promoting a Healthy Life Through Gender Equity
|
||
Completed |
NCT03849924 -
Enhancing One's Sense of Self Using Self-Affirmation
|
N/A | |
Active, not recruiting |
NCT05541653 -
The IGNITE Study on Concentrated Investment in Black Neighborhoods
|
N/A | |
Completed |
NCT03303326 -
Arab American Women's Health Study
|
N/A | |
Not yet recruiting |
NCT05542537 -
Nurturing Healthy Teachers
|
N/A | |
Completed |
NCT02785471 -
Assessing Online Interventions for Men's' Mental Health and Wellbeing
|
N/A | |
Completed |
NCT02683811 -
Effectiveness of the Updated Version of the School-based Program Diario Della Salute (DDS-2)
|
N/A | |
Withdrawn |
NCT05605028 -
A Mental Health Intervention for a Community Program Called the PowerObesity
|
N/A | |
Not yet recruiting |
NCT04537676 -
Patient Empowerment Study
|
||
Recruiting |
NCT06324318 -
Parenting in 2 Worlds Multisite Trial
|
Phase 2 | |
Completed |
NCT05455905 -
Voice Biomarkers Predictive of Depression and Anxiety
|
||
Completed |
NCT03368014 -
"Fun.Feel.Share" Lyrics-writing and Singing Show
|
N/A | |
Completed |
NCT05109923 -
Onnit Labs New Mood Supplementation in Healthy College Students
|
N/A | |
Not yet recruiting |
NCT05825040 -
Randomized Controlled Trial on Precision Mental Health
|
N/A | |
Not yet recruiting |
NCT06023342 -
Examining Engagement Predictors of Health and Fitness App Uptake and Subscription in the General Population
|
||
Completed |
NCT06044363 -
Satir Model for Self-esteem, Mental Health, and Family Function Among Individuals With Substance Use Disorders
|
N/A | |
Recruiting |
NCT04790162 -
Heartfulness Meditation to Improve Resilience Among Health Care Students: A 90 Day Program
|
N/A |