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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03779204
Other study ID # 18-251
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 28, 2019
Est. completion date March 31, 2022

Study information

Verified date September 2022
Source Unity Health Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Compared to the vast amount of literature about the risk factors associated with young people entering and becoming entrenched in homelessness, much less is known about how to facilitate and sustain transitions off the streets. Current evidence indicates that while structural supports such as subsidized housing and social service providers are important, these things alone are insufficient to help young people integrate into mainstream society. Connecting these young people with an adult who exhibits the relationship-based components of mentoring that young people value most (e.g., genuine interest in their well-being and belief in their ability to succeed, a non-judgmental attitude and a willingness to listen, the provision of advice, guidance, affirmation and encouragement) may be key to helping them move forward and integrate into the mainstream. This intervention will provide 24 young people (ages 18-26) who have transitioned out of homelessness and into market rent housing within the past year with rent subsidies for 24 months. Half of the young people will be randomized to receive regular mentorship from an adult mentor, tasked with helping their mentee bridge the gap between homelessness and mainstream living. It is hypothesized that, for the primary outcome measures of community integration and self-esteem: 1. Better mean scores (community integration and self-esteem) in the participants who receive rent subsidies plus mentorship (intervention group) will be observed compared to the participants who receive rent subsidies only (control group) by the primary endpoint of 18 months of study participation. It is hypothesized that, for the secondary outcome measures of social connectedness, hope, and academic and vocational participation: 1. Better mean scores (social connectedness and hope) in the intervention group relative to participants in the control group will be observed by 18 months of study participation. 2. Participants in the intervention group will be more likely than the control group to demonstrate sustained engagement in academic and vocational activities (education, employment, and/or skills training) by 18 months of study participation. This pilot will be the first to test the impact of economic and social supports on meaningful social integration for formerly homeless young people living in market rent housing.


Description:

The overarching aim of this mixed methods study is to assess whether and how rent subsidies and mentorship influence social integration outcomes for formerly homeless young people living in market rent housing in three urban settings. Specifically, the objectives of this study are to: 1. Determine whether rent subsidies plus mentorship results in better social integration outcomes than only receiving rent subsidies with respect to: a) community integration (psychological and physical); and b) self-esteem at the primary endpoint of 18 months. 2. Determine whether rent subsidies plus mentorship results in better social integration outcomes than only receiving rent subsidies with respect to: a) social connectedness; b) hope; and c) sustained academic and vocational participation at 18 months. 3. Explore whether rent subsidies plus mentorship results in better social integration outcomes than only receiving rent subsidies with respect to: a) income; b) perceived housing quality; c) psychiatric symptoms; and d) sense of engulfment at 18 months. 4. Integrate qualitative data to facilitate a fuller understanding of the quantitative data and deepen understanding of what the study participants (young people and mentors) found most beneficial about the intervention and how it could be improved. This study will employ a convergent mixed methods design (i.e., quantitative and qualitative data are collected concurrently, and the findings combined) embedded within a randomized controlled trial (RCT) and a community-based participatory action research (CBPAR) framework. A mixed methods RCT is appropriate given the complex explanatory pathways (i.e., social and behavioral processes that may act independently and interdependently) of this intervention. In addition, the qualitative data will provide insights on contextual factors that may impact the external validity of the findings. Most importantly, this design provides a crucial (and under utilized) youth-informed perspective on social integration. The study will be conducted in three Canadian cities: Toronto, Ontario (pop. 2.8 million); Hamilton, Ontario (pop. 552,000); and St. Catharines, Ontario (pop. 133,000). All of the study participants (n = 24) will receive rent subsidies (ranging from $400 - $500/month) for 24 months as a part of the intervention. This study includes funding for the rent subsidies and will be paid directly to the landlords by the community partners. St. Michael's Hospital will establish a service provider agreement with each of the community partners for this purpose. Participants in the intervention group (n = 12) will be matched with an adult mentor recruited by one of the community partners. The mentors will be encouraged to incorporate the key relationship-based components of natural mentors (e.g., a 'coach' or 'cheerleader' role) to assist with mainstream integration. To facilitate more of an organic, natural mentor-mentee relationship, the mentors will have more flexibility than a typical formal mentorship program in the types of activities they pursue with their mentees. For example, they will not be mandated to attend shelter-based social events. Instead, mentors will be encouraged to initiate activities that direct their mentees away from the shelter system (and their old identities as homeless youth) and toward the mainstream (e.g., meeting for coffee at a local university campus, touring a local library, or visiting the mentor's place of employment during business hours). All of the mentors will meet monthly with their mentees for two years. In addition, the mentor will be encouraged to touch base with their mentee via phone or text message every week. If a mentor is unable to continue their role and there are at least six months left in the study, the study participant will be matched with a new mentor. Community partners will match all participants with an outreach worker (already employed by each agency) who will communicate regularly with the research team, help ensure the rent subsidies are being distributed appropriately, maintain an ongoing relationship with the study participants, and monitor for 'red flags' in participants matched in mentor-mentee relationships (e.g., mentee reluctant to meet with their mentor). Matching all of the study participants with a worker will also help ensure that everyone is receiving a fairly equal level of social support from community partners, making it easier for the research team to discern whether the outcomes of interest are more likely attributable to mentorship rather than to varied levels of agency-based support. Moreover, a review of services and interventions designed to reduce "problem behaviors" (e.g., substance use and risky sexual practices) among street-involved and homeless young people (ages 12 - 24) found that researchers who had strong relationships with outreach workers and the community had more effective interventions and lower attrition rates than those who did not. Following the baseline interview, participants at each of the three study sites (Toronto (n=12), Hamilton (n=6), and St. Catharine's (n=6)) will be randomized using block randomization to either the intervention (rent subsidies plus mentoring) or control (rent subsidies only) group. Randomization will be balanced by site based on random block sizes of two and four. The advantage of using block randomization is to uniformly distribute participants into treatment groups within each site. Because small block sizes may increase the risk of guessing the allocation procedure and subsequently introducing bias into the enrolment procedure, random block sizes will be used to avoid this potential selection bias. A unique randomization schedule will be produced for each site using SAS. A research coordinator not affiliated with the study will be the only person with access to the randomization schedule. The research coordinator will prepare sealed, opaque and sequentially numbered envelopes with the randomization results of participants. After assessing for eligibility and obtaining consent of each participant, research personnel responsible for enrolling participants will open the next randomization envelope from the sequentially ordered randomization envelope file to obtain the participant's randomized group assignment. Quantitative data will be collected at six points in time over the course of 30 months: baseline, month six, month 12, month 18, month 24, and month 30. Qualitative measures are an important feature of this study and will consist of: 1) semi-structured individual interviews (study participants) and 2) focus groups (mentors). At baseline, twelve participants (six from each arm of the study) will be invited to participate in six semi-structured individual interviews, which will take place at the same time as the quantitative data collection: baseline, month six, month 12, month 18, month 24, and month 30. Participants will be purposively selected with a goal of having input from each of the three communities and a fairly equal gender and ethno-racial representation. All of the mentors (n = 12) will be invited to participate in two focus groups, which will take place at month 12 and month 24. All analyses will be performed using the intention-to-treat principle; that is, all participants will be included and analyzed in the groups they were originally randomized. Baseline characteristics of the intervention and control groups will be summarized using descriptive statistics (i.e., mean, standard deviation, median and interquartile range for continuous variables, and frequencies and proportions for categorical variables). The descriptive statistics for outcomes at each study time point will be calculated, and differences in trajectories from baseline to 30 months follow-up between intervention and control groups using scatterplots and box-plots will be explored. Differences with 95% confidence intervals in continuous outcomes at 18 months (psychological community integration, self-esteem, social connectedness, hope, perceived housing quality, psychiatric symptoms, and sense of engulfment) between participants who received rent subsidies plus mentorship and participants who only received rent subsidies will be estimated using Analysis of Covariance (i.e., linear regression models), including an indicator of intervention group and the baseline value of the outcome. Regression diagnostics will be performed and analyses using the non-parametric Wilcoxon rank-sum test will be repeated if there are extreme outliers or influential observations. Groups will be compared with respect to count outcomes at 18 months (physical community integration) using graphical tools and the non-parametric Wilcoxon rank-sum test. For binary outcomes at 18 months (sustained academic and vocational participation, and income above low income cut-off ), differences in proportions with 95% confidence intervals will be estimated and tested using the chi-square or Fisher's exact test. Given the small sample size of this pilot randomized trial, all results will be interpreted with caution and with the intention of generating data and hypotheses for conducting a larger trial. Given the emergent, iterative nature of research using a qualitative design, data analysis and interpretation will begin immediately after the first qualitative data generation session (at baseline). The semi-structured individual interviews and focus groups will be audio recorded and transcribed verbatim. In order to conduct a more nuanced analysis of the data, the transcriptionist will be instructed to note short responses, uncooperative tones, and literal silence. Prior to each subsequent qualitative data generation session, members of the research team will conduct a preliminary data analysis, reading the interview transcripts multiple times, separating the data into coded segments, making analytic memos beside sections of the transcripts, identifying emerging themes (and comparing/contrasting these between respondents), and compiling new questions. Those participating in the individual interviews and the focus groups will be asked for their perspectives on the emerging interpretations at each visit and these perspectives will play a key role in helping shape the data analysis and help ensure the trustworthiness of the data. The web-based application Dedoose will be utilized to assist with sorting and coding the qualitative data. In keeping with CBPAR methodology, disseminating evidence with community partners is key in building community capacity and improving the lives of the young people participating in this study. Moreover, given the use of Critical Social Theory, the study findings will not only be presented, but will also be used to expose and explicate the relational processes (e.g., subjective experience of low socioeconomic position and low social class) that may be preventing formerly homeless young people from achieving meaningful social integration. With an emphasis on 'actionable' data, the findings will be disseminated broadly to both academic and community-based audiences in a variety of formats ranging from scientific journal papers to oral presentations.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date March 31, 2022
Est. primary completion date March 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 26 Years
Eligibility Inclusion Criteria: - Be between ages 18-26 - Left homelessness within the past year - Living in market rent housing - Plan on staying in or nearby the community in which they were recruited (Toronto, Hamilton, or St. Catharines) for the duration of the 24-month study - Be willing to be matched with an adult mentor who has been screened and chosen by one of the community partners Exclusion Criteria: - In imminent danger of losing their housing (e.g., facing jail time or impending eviction) - Enrolled in another study with enhanced financial and social supports - Unable to provide free and informed consent - Unable to communicate fluently in English

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Mentorship
The mentors will be encouraged to incorporate the key relationship-based components of natural mentors (e.g., a 'coach' or 'cheerleader' role) to assist with mainstream integration. The mentors will have more flexibility than a typical formal mentorship program in the types of activities they pursue with their mentees. They will not be mandated to attend shelter-based social events, but rather engage in activities that direct their mentees away from the shelter system (and their old identities as homeless youth) and toward the mainstream (e.g., meeting for coffee at a local university campus). All of the mentors will meet monthly with their mentees for two years. In addition, the mentor will be encouraged to touch base with their mentee via phone or text message every week. If a mentor is unable to continue their role and there are at least six months left in the study, the study participant will be matched with a new mentor.
Rent Subsidies
Participants will receive rent subsidies ($500 for those living in Toronto, $400 for those living in Hamilton or St. Catherine's due to differences in cost of living) for 24 months.

Locations

Country Name City State
Canada St. Michael's Hospital Toronto Ontario

Sponsors (4)

Lead Sponsor Collaborator
Unity Health Toronto Covenant House Toronto, The Living Rock Ministries, The Resource Association for Teens (RAFT)

Country where clinical trial is conducted

Canada, 

References & Publications (63)

Altena AM, Brilleslijper-Kater SN, Wolf JL. Effective interventions for homeless youth: a systematic review. Am J Prev Med. 2010 Jun;38(6):637-45. doi: 10.1016/j.amepre.2010.02.017. Review. — View Citation

Beck AT, Weissman A, Lester D, Trexler L. The measurement of pessimism: the hopelessness scale. J Consult Clin Psychol. 1974 Dec;42(6):861-5. — View Citation

Brueckner, M., Green, M., & Saggers, S. (2011). The trappings of home: Young homeless people's transitions towards independent living. Housing Studies, 26(1), 1-16. doi:10.1080/02673037.2010.512751.

Chenail. R. J., St. Goerge, S., Wulff, D., & Cooper, R. (2012). Action research: The methodologies. In P. L. Munhall (Ed.), Nursing research: A qualitative perspective (5th ed.) (pp. 455-470). Sudbury, MS: Jones & Bartlett.

Ciarolo, J. A., Edwards, D. W., Kiresuk, T. J., Newman, F. L., & Brown, T. R. (1981). Colorado symptom index. Washington, DC: National Institute of Mental Health.

Coren E, Hossain R, Pardo Pardo J, Bakker B. Interventions for promoting reintegration and reducing harmful behaviour and lifestyles in street-connected children and young people. Cochrane Database Syst Rev. 2016 Jan 13;(1):CD009823. doi: 10.1002/14651858.CD009823.pub3. Review. — View Citation

Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M; Medical Research Council Guidance. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008 Sep 29;337:a1655. doi: 10.1136/bmj.a1655. — View Citation

Creswell, J.W. (2014). Research design: Qualitative, quantitative, and mixed method approaches (4th ed.). Thousand Oaks, CA: Sage.

Creswell, J.W., & Plano Clark, V.L. (2018). Designing and conducting mixed methods research (3rd ed.). Thousand Oaks, CA: Sage.

Dang MT, Miller E. Characteristics of natural mentoring relationships from the perspectives of homeless youth. J Child Adolesc Psychiatr Nurs. 2013 Nov;26(4):246-53. doi: 10.1111/jcap.12038. Epub 2013 Jun 14. — View Citation

Denzin, N.K., & Lincoln, Y.S. (2011). The SAGE handbook of qualitative research. Thousand Oaks, CA: SAGE Publications Inc.

Eakin JM, Mykhalovskiy E. Reframing the evaluation of qualitative health research: reflections on a review of appraisal guidelines in the health sciences. J Eval Clin Pract. 2003 May;9(2):187-94. — View Citation

Efird J. Blocked randomization with randomly selected block sizes. Int J Environ Res Public Health. 2011 Jan;8(1):15-20. doi: 10.3390/ijerph8010015. Epub 2010 Dec 23. — View Citation

Farquhar MC, Ewing G, Booth S. Using mixed methods to develop and evaluate complex interventions in palliative care research. Palliat Med. 2011 Dec;25(8):748-57. doi: 10.1177/0269216311417919. Epub 2011 Aug 1. — View Citation

Fletcher, R.H., Fletcher, S.W., & Fletcher, G.S. (2014). Clinical epidemiology: The essentials (5th ed.). Philadelphia, PA: Lippincott Williams & Wilkins.

Frederick, T., Chwalek, M., Hughes, J., Karabanow, J., & Kidd, S. (2014). How stable is stable? Defining and measuring housing stability. Journal of Community Psychology, 42(8), 964- 979. doi:10.1002/jcop.21665.

Gaetz, S. (2014). Coming of age: Reimagining the response to youth homelessness in Canada. Toronto, ON: The Canadian Homelessness Research Network Press. Retrieved from http://www.homelesshub.ca/comingofage

Gaetz, S., & Redman, M. (2016). Federal investment in youth homelessness: Comparing Canada and the United States and a proposal for reinvestment. Canadian observatory on homelessness policy brief. Toronto, ON: The Homeless Hub Press. Retrieved from http://homelesshub.ca/sites/default/files/Policy_Brief.pdf

Gaetz, S., Dej, E., Richter, T., & Redman, M. (2016) The state of homelessness in Canada 2016. Toronto, ON: Canadian Observatory on Homelessness Press. Retrieved from http://www.homelesshub.ca/SOHC2016

Gaetz, S., O'Grady, B., Kidd, S., & Schwan, K. (2016). Without a home: The national youth homelessness survey. Toronto: Canadian Observatory on Homelessness Press. Retrieved from http://homelesshub.ca/sites/default/files/WithoutAHome-final.pdf

Goodkind JR, Amer S, Christian C, Hess JM, Bybee D, Isakson BL, Baca B, Ndayisenga M, Greene RN, Shantzek C. Challenges and Innovations in a Community-Based Participatory Randomized Controlled Trial. Health Educ Behav. 2017 Feb;44(1):123-130. doi: 10.1177/1090198116639243. Epub 2016 Jul 10. — View Citation

Hammersley, M., & Atkinson, P. (2007). Ethnography: Principles in Practice (3rd ed.). London, UK: Routledge.

Hwang SW, Burns T. Health interventions for people who are homeless. Lancet. 2014 Oct 25;384(9953):1541-7. doi: 10.1016/S0140-6736(14)61133-8. Review. — View Citation

Israel, B.A., Schulz, A.J., Parker, E.A., Becker, A.B., Allen, III, Guzman, R.J., & Lichtenstein, R. (2018). Critical issues in developing and following CBPR principles. In N. Wallerstein, B. Duran, J. Oetzel, & M. Minkler (Eds.), Community-based participatory research for health: Advancing social and health equity (3rd ed.) (pp. 31-44). San Francisco, CA: Jossey-Bass

Karabanow, J. (2008). Getting off the street: Exploring the process of young people's street exits. American Behavioral Scientist, 51(6), 772-788. doi:10.1177/0002764207311987.

Karabanow, J., Carson, A., & Clement, P. (2010). Leaving the streets: Stories of Canadian youth. Halifax, NS: Fernwood Publishing.

Karabanow, J., Kidd, S., Frederick, T., & Hughes, J. (2016). Toward housing stability: Exiting homelessness as an emerging adult. Journal of Sociology & Social Welfare, 43(1), 121- 148. Retrieved from https://wmich.edu/socialworkjournal

Kawabata, M., & Gastaldo, D. (2015). The less said, the better: Interpreting silence in qualitative research. International Journal of Qualitative Research Methods, 14(4), 1-9. doi:10.1177/1609406915618123.

Kidd, S.A., Frederick, T., Karabanow, J., Hughes, J., Naylor, T., & Barbic, S. (2016). A mixed methods study of recently homeless youth efforts to sustain housing and stability. Child and Adolescent Social Work Journal, 33(3), 207-218. doi:10.1007/s10560-015-0424.

Kozloff N, Adair CE, Palma Lazgare LI, Poremski D, Cheung AH, Sandu R, Stergiopoulos V. "Housing First" for Homeless Youth With Mental Illness. Pediatrics. 2016 Oct;138(4). pii: e20161514. — View Citation

Kulik DM, Gaetz S, Crowe C, Ford-Jones EL. Homeless youth's overwhelming health burden: A review of the literature. Paediatr Child Health. 2011 Jun;16(6):e43-7. — View Citation

Kusenbach, M. (2003). Street phenomenology: The go-along as ethnographic research tool. Ethnography, 4(3), 455-485. doi: 10.1177/146613810343007.

Lee, R. M., & Robbins S. B. (1995). Measuring belongingness: The social connectedness and the social assurance scales. Journal of Counseling Psychology, 42(2), 232-241. doi: 10.1037/0022-0167.42.2.232.

Lewin S, Glenton C, Oxman AD. Use of qualitative methods alongside randomised controlled trials of complex healthcare interventions: methodological study. BMJ. 2009 Sep 10;339:b3496. doi: 10.1136/bmj.b3496. Review. — View Citation

Loiselle, C.G., Profetto-McGrath, J., Polit, D.F., & Tatano Beck, C.T. (2004). Canadian essentials of nursing research. Philadelphia, PA: Lippincott Williams & Wilkins.

Luchenski S, Maguire N, Aldridge RW, Hayward A, Story A, Perri P, Withers J, Clint S, Fitzpatrick S, Hewett N. What works in inclusion health: overview of effective interventions for marginalised and excluded populations. Lancet. 2018 Jan 20;391(10117):266-280. doi: 10.1016/S0140-6736(17)31959-1. Epub 2017 Nov 12. Review. — View Citation

Madison, D.S. (2012). Critical ethnography: Method, ethics, and performance (2nd ed.). Thousand Oaks, CA: Sage Publication, Inc.

Mayock, P., O'Sullivan, E., & Corr, M.L. (2011). Young people exiting homelessness: An exploration of process, meaning and definition. Housing Studies, 26(6), 803-826. doi:10.1080/02673037.2011.593131.

McCay, E., Carter, C., Aiello, A., Quesnel, S., Langley, J., Hwang, S., .... Karabanow, J. (2015). Dialectical Behavior Therapy as a catalyst for change in street-involved youth: A mixed methods study. Children and Youth Services Review, 58, 187-199. doi: 10.1016/j.childyouth.2015.09.021.

Milburn NG, Rice E, Rotheram-Borus MJ, Mallett S, Rosenthal D, Batterham P, May SJ, Witkin A, Duan N. Adolescents Exiting Homelessness Over Two Years: The Risk Amplification and Abatement Model. J Res Adolesc. 2009 Dec 1;19(4):762-785. — View Citation

Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, Moore L, O'Cathain A, Tinati T, Wight D, Baird J. Process evaluation of complex interventions: Medical Research Council guidance. BMJ. 2015 Mar 19;350:h1258. doi: 10.1136/bmj.h1258. — View Citation

Ontario Human Rights Commission. (n.d.). Housing as a human right. Retrieved from http://www.ohrc.on.ca/en/right-home-report-consultation-human-rights-and-rental-housing-ontario/housing-human-right

Popay, J., Escorel, S., Hernandez, M., Johnston, H., Mathieson, J., & Rispel, L. (2008). Understanding and tackling social exclusion: Final report to the WHO commission on social determinants of health from the social exclusion knowledge network. Retrieved from http://www.who.int/social_determinants/themes/socialexclusion/en/

Prasad, P. (2005). Crafting qualitative research: Working in the postpositivist traditions. New York, NY: M.E. Sharpe.

Public Interest. (2009). Changing patterns for street involved youth. Toronto, ON: Author. Retrieved from http://www.worldvision.ca/Programs-and- Projects/Canadian Programs/Documents/ChangingPatternsForStreetInvolvedYouth.pdf

Quilgars, D., & Pleace, N. (2016). Housing First and Social Integration: A Realistic Aim? Social Inclusion, 4(4), 5-15. doi:10.17645/si.v4i4.672.

Rosenberg, M. (1965). Society and the adolescent self-image. Princeton, NJ: Princeton University Press.

Rutman, A., Hubberstey, A., Barlow, A., & Brown, E. (2005). Supporting young people's transitions from care: Reflections on doing participatory action research with youth from care. In L. Brown & S. Strega (Eds.), Research as resistance: Critical, Indigenous, & anti-oppressive approaches (pp. 153-179). Toronto, ON: Canadian Scholars' Press/Women's Press.

Slesnick N, Dashora P, Letcher A, Erdem G, Serovich J. A Review of Services and Interventions for Runaway and Homeless Youth: Moving Forward. Child Youth Serv Rev. 2009 Jul;31(7):732-742. — View Citation

SocioCultural Research Consultants, LLC. (2018). Dedoose (Version 8.0.35) [web application]. Retrieved from http://www.dedoose.com

Solar, O., & Irwin, A. (2010). A conceptual framework for action on the social determinants of health: Social determinants of health discussion paper 2. Geneva, Switzerland: World Health Organization Press. Retrieved from http://www.who.int/sdhconference/resources/ConceptualframeworkforactiononS DH_eng.pdf

Solomon, P., Cavanaugh, M.M., & Draine, J. (2009). Randomized controlled trials: Design and implementation for community-based psychosocial interventions. New York, NY: Oxford University Press.

Stergiopoulos V, Gozdzik A, O'Campo P, Holtby AR, Jeyaratnam J, Tsemberis S. Housing First: exploring participants' early support needs. BMC Health Serv Res. 2014 Apr 13;14:167. doi: 10.1186/1472-6963-14-167. — View Citation

Strega, B. (2005). The view from the poststructural margins: Epistemology and methodology reconsidered. In L. Brown & S. Strega (Eds.), Research as resistance: Critical, Indigenous, & anti-oppressive approaches (pp. 199-235). Toronto, ON: Canadian Scholars' Press/Women's Press.

Suresh K. An overview of randomization techniques: An unbiased assessment of outcome in clinical research. J Hum Reprod Sci. 2011 Jan;4(1):8-11. doi: 10.4103/0974-1208.82352. — View Citation

Thompson, A. E., Greeson, J. K., & Brunsink, A. M. (2016). Natural mentoring among older youth in and aging out of foster care: A systematic review. Children and Youth Services Review, 61, 40-50. doi: 10.1016/j.childyouth.2015.12.006.

Thulien NS, Gastaldo D, Hwang SW, McCay E. The elusive goal of social integration: A critical examination of the socio-economic and psychosocial consequences experienced by homeless young people who obtain housing. Can J Public Health. 2018 Feb;109(1):89-98. doi: 10.17269/s41997-018-0029-6. — View Citation

Toro PA, Passero Rabideau JM, Bellavia CW, Daeschler CV, Wall DD, Thomas DM, Smith SJ. Evaluating an intervention for homeless persons: results of a field experiment. J Consult Clin Psychol. 1997 Jun;65(3):476-84. — View Citation

Urbaniak, G.C., & Plous,S. (2013). Research Randomizer (Version 4.0) [Computer software]. Retrieved from https://www.randomizer.org

Van Dam L, Smit D, Wildschut B, Branje SJT, Rhodes JE, Assink M, Stams GJJM. Does Natural Mentoring Matter? A Multilevel Meta-analysis on the Association Between Natural Mentoring and Youth Outcomes. Am J Community Psychol. 2018 Sep;62(1-2):203-220. doi: 10.1002/ajcp.12248. Epub 2018 Apr 25. Review. — View Citation

Wallerstein N, Duran B. Community-based participatory research contributions to intervention research: the intersection of science and practice to improve health equity. Am J Public Health. 2010 Apr 1;100 Suppl 1:S40-6. doi: 10.2105/AJPH.2009.184036. Epub 2010 Feb 10. — View Citation

Wallerstein NB, Duran B. Using community-based participatory research to address health disparities. Health Promot Pract. 2006 Jul;7(3):312-23. Epub 2006 Jun 7. — View Citation

Wallerstein, N., Duran, B., Oetzel, J.G., & Minkler, M. (2018). Community-based participatory research for health: Advancing social and health equity (3rd ed.). San Francisco, CA: Jossey-Bass.

* Note: There are 63 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other Mean Change from Baseline in Engulfment Scores as Measured by the Modified Engulfment Scale (ES) at 18 months This is an exploratory outcome. This outcome is a measure of the degree to which an individual's self-concept is defined by their experience of homelessness. It will be assessed using the Modified Engulfment Scale, a 30-item scale, internal consistency a = .91. The total scoring range is 30-150, 30 being low engulfment, 150 being high engulfment.
The scale was adapted for use in this study, substituting "experience of homelessness" for "illness".
This outcome is assessed for change at 18 months, and the overall trajectory described over 30 months.
Assessed every 6 months for 30 months, after introduction of the mentor to the participant
Other Mean Change from Baseline in Psychiatric Symptoms as Measured by the Modified Colorado Symptom Index (CSI) at 18 months This is an exploratory outcome; it is the measurement of the presence and frequency of psychiatric symptoms experienced in the past month. Measured using the Modified Colorado Symptom Index, a 14-item questionnaire, internal consistency a = .90 - .92. The total scoring range is 0-56, 0 being a low frequency of psychiatric symptoms, and 56 being a high frequency of psychiatric symptoms. This outcome is assessed for change at 18 months, and the overall trajectory described over 30 months. Assessed every 6 months for 30 months, after introduction of the mentor to the participant
Other Change in Income as Assessed by a Questionnaire at 18 months This is an exploratory outcome. Participants will be prompted to answer questions about their current income every 6 months in a questionnaire. This outcome is assessed using a repeated measures analysis and changes in income will be assessed for change over time at the aggregate level. This outcome is assessed for change at 18 months, and the overall trajectory described over 30 months. Assessed every 6 months for 30 months, after introduction of the mentor to the participant
Other Mean Change from Baseline in Perceived Housing Quality as Measured by the Perceived Housing Quality Scale (PHQS) at 18 months This is an exploratory outcome and is assessed by participant perception of housing choice and quality. Measured using the Perceived Housing Quality Scale.This scale was used extensively in the Chez Soi/At Home study, but psychometric properties have yet to be reported. It has been shortened it from 10 items (Chez Soi/At Home) to seven relevant items. The total scoring range is 7-35, 7 being very dissatisfied with current housing quality, and 35 being very satisfied with housing quality. This outcome is assessed for change at 18 months, and the overall trajectory described over 30 months. Assessed every 6 months for 30 months, after introduction of the mentor to the participant
Other Participant Perspectives of Intervention Barriers and Facilitators, as Informed by Interviews with Participants and Focus Groups with Case Workers at 18 months This is an exploratory outcome. Through interviews and focus groups, youth will be able to indicate what aspects of the program they found most effective. Understanding of the strengths and weaknesses of the intervention is expected to increase over time. Assessed every 6 months for 30 months, after introduction of the mentor to the participant
Primary Mean Change from Baseline in Community integration (psychological and physical) Scores as Measured by the Community Integration Scale (CIS) at 18 Months This outcome is a measure of behavioural (e.g., participation in activities) and psychological (e.g., sense of belonging) aspects of community integration. This will be measured using the Community Integration Scale, an 11-item scale. The CIS includes a psychological subscale (scores possible range from 4-20, 4 being low psychological community integration and 20 being high integration), and a physical subscale (total scoring range is 0-7, 0 being low physical community integration, and 7 being high integration). This scale was used extensively in the Chez Soi/At Home study, but psychometric properties have yet to be reported.
This outcome is assessed for change at 18 months, and the overall trajectory described over 30 months.
Assessed every 6 months for 30 months, after introduction of the mentor to the participant
Primary Mean Change from Baseline in Self-esteem Scores as Measured by the Rosenberg Self-Esteem Scale (RSS) at 18 Months This outcome is a measure of global self-worth and will be measured using the Rosenberg Self-Esteem Scale, a 10-item scale, internal consistency a = .77 - .88. The total scoring range is 0-30, a score of <15 is categorized as low self-esteem, and 15-30 is categorized as normal self-esteem. This outcome is assessed for change at 18 months, and the overall trajectory described over 30 months. Assessed every 6 months for 30 months, after introduction of the mentor to the participant
Secondary Mean Change from Baseline in Social Connectedness Scores as Measured by the Social Connectedness Scale (SCS) at 18 Months This outcome is a measure of belongingness - the degree to which people feel connected to others. It is measured using the Social Connected Scale, a 20-item scale, internal consistency a = .92. The total scoring range is 20-120, 20 being low social connectedness and 120 being high social connectedness. This outcome is assessed for change at 18 months, and the overall trajectory described over 30 months. Assessed every 6 months for 30 months, after introduction of the mentor to the participant
Secondary Mean Change from Baseline in Hope as Measured by the Beck Hopelessness Scale at 18 Months This outcome is a measure of motivation, expectations, and feelings about the future and will be measured using Beck's Hopelessness Scale, a 20-item scale, internal consistency a = .93. The total scoring range is 0-20, 0-3 = None or minimal, 4-8 = Mild, 9-14 = Moderate - requires monitoring, 15+ = Severe - suicide risk. This outcome is assessed for change at 18 months, and the overall trajectory described over 30 months. Assessed every 6 months for 30 months, after introduction of the mentor to the participant
Secondary Change in Academic Participation/Educational Attainment as Assessed by a Questionnaire at 18 Months Participant engagement with school or a training program will be assessed. Participants will be prompted to answer questions about their current educational pursuit every 6 months in a questionnaire, including whether the individual is pursuing education, and the type of education. This outcome is assessed for change at 18 months, and the overall trajectory described over 30 months. Assessed every 6 months for 30 months, after introduction of the mentor to the participant
Secondary Change in Vocational Participation/Employment as Assessed by a Questionnaire at 18 months Acquirement of meaningful employment will be assessed. Participants will be prompted to answer questions about their current employment status every 6 months in the questionnaire, including whether they are employed, the type of employment, and the intensity of the employment (hours per month). This outcome is assessed for change at 18 months, and the overall trajectory described over 30 months. Assessed every 6 months for 30 months, after introduction of the mentor to the participant
See also
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