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YouthTIPNCT03772522

The Identity Project

A study testing dk Leadership in people with Youth and Homelessness, run by Unity Health Toronto at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Understanding how to create successful pathways out of homelessness is crucial. Thirty young people (aged 18 - 26 years) who have transitioned out of homelessness within the past three years will be offered scholarships to participate in a six week intervention that focuses on building identity capital (sense of… Read more about this study

Who is it for?
Ages 18 to 26 yearsHealthy volunteers can take part
Conditions the study is for
Youth, Homelessness
What is being tested?
dk Leadership
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
27 participants
Where
1 siteCanada
Study dates
1 Apr 2018to 6 Aug 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 26 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Between 18-26 years of age
  • Left homelessness within the last 3 years (youth living in supportive housing contexts (e.g., transitional housing) will be considered to have left homelessness)
  • Currently not homeless (youth in supportive or transitional housing are eligible)
  • A concerted effort will be made to recruit young people facing additional identity-related challenges like newcomer and racialized youth, Indigenous youth, and youth who belong to the LGBTQ2S community.

Who cannot join

  • Not fluent in English
  • Cannot provide informed consent
  • Cannot commit to attending two full-day workshops and four half-day group coaching sessions over the course of six weeks (missing more than one workshop and two coaching sessions will disqualify participants from the study)

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • St. Michael's Hospital

    Toronto, Ontario

Other trials in Canada

About this study

Official title: The Identity Project: An Evaluation of an Identity Capital Intervention for Young People Transitioning Out of Homelessness

Understanding how to create successful pathways out of homelessness is crucial. Thirty young people (aged 18 - 26 years) who have transitioned out of homelessness within the past three years will be offered scholarships to participate in a six week intervention that focuses on building identity capital (sense of purpose and control, self-efficacy and self-esteem) and providing career direction. The intervention will be designed and carried out by dk Leadership - an established, highly successful leadership and counseling centre in Toronto with a track record of significantly improving the life trajectories of teens and adults. Importantly, study participants will be incorporated into the centre's current programming, meaning the intervention will be held at a location not associated with homelessness. Study participants will be collaboratively recruited by dk Leadership and Covenant House Toronto - Canada's largest agency for street-involved and homeless youth.

This impact and process evaluation aims to address critical gaps in knowledge about transition-related supports by asking whether and how an identity capital intervention delivered outside the social service sector impacts the life-trajectories of formerly homeless young people. Particular attention will be paid to whether this intervention shows promise as an unconventional way to tackle poverty and improve social inclusion.

Read more

It is hypothesize that, for the primary quantitative outcome measures of hope, community integration, social connectedness, and self-esteem:

  1. Significant improvements in the mean scores of the intervention group compared to the delayed intervention comparison group immediately post-intervention will be observed.
  2. Significant improvements in the mean scores of both groups (intervention and delayed intervention) immediately post-intervention will be observed.
  3. These significant improvements will be sustained in both groups for at least three months post-intervention.
Read the detailed description

Young people comprise almost 20% of the homeless population in Canada. It is estimated between 35,000 and 40,000 Canadian youth (aged 13 - 25 years) are homeless at some point during the year and at least 6,000 on any given night. In Toronto, an estimated 1,000 - 2,000 youth find themselves searching for a place to sleep on any given night.

While a great deal is known about the risk factors associated with young people entering and remaining entrenched in street life (e.g., intergenerational poverty, childhood abuse, inadequate education, and limited employment opportunities), less is known much less about how to facilitate and sustain transitions off the streets for youth experiencing homelessness.

The scarcity of evidence on this issue means there are critical gaps in understanding how best to help homeless young people move forward in life after they become housed. For example, results from a recent longitudinal mixed method study of 51 formerly homeless youth living in Toronto and Halifax - led by Dr. Sean Kidd and colleagues and one of the most rigorous investigations to date - showed that obtaining stable housing did not necessarily translate into a sense of belonging or connection to mainstream society. While study participants demonstrated incredible commitment, the structural barriers they experienced during the transition process (e.g., inadequate education and underemployment) led to fragile identities (i.e., self-concept) as they experienced a significant decline in hope and a sense of being 'stuck'. Youth described feeling unprepared for and overwhelmed by the realities associated with the transition process, undermining their sense of belonging and confidence in achieving larger life goals.

Building on the Kidd et al. study, Dr. Naomi Thulien (the lead investigator for this study) spent 10 months following nine young people who had left the shelter system and moved into market rent housing in Toronto. The study - believed to be the first of its kind - captured the crucial role identity plays in the transition away from homelessness. Despite their remarkable determination, study participants lacked sufficient identity capital - conceptualized as a sense of purpose and control, self-efficacy, and self-esteem - to help them press on in the face of significant structural inequities. Thulien asserts that failure to understand and incorporate identity capital into transition-related supports may result in a poor return on investment as these supports are likely to be ineffective, underutilized, or rejected outright.

One notable identity-based intervention is a randomized controlled trial that targeted 264 eighth graders from high-poverty and high-unemployment neighborhoods in Detroit, Michigan. Participants who attended the seven-week intervention aimed at aligning the students' current identities with achievable positive adult identities, demonstrated improved outcomes on measures pertaining to academics, mood, and behavior, which was sustained through the two-year follow-up. The authors suggest brief identity-based interventions can have significant effects on outcomes. Despite being suggested as a promising approach, the investigators know of no other interventions (nationally or internationally) that are specifically targeting the enhancement of identity capital for formerly homeless young people. Given the limited evidence-based interventions for youth transitioning out of homelessness, the investigators believe there is a critical need for evaluations that compare findings based on different approaches, reflecting the diversity of the population and their corresponding needs.

The proposed intervention is based on two premises: 1) identity is socially constructed and malleable; and 2) people act in identity-congruent ways. Thus, the intervention aims to change socially constructed life trajectories by providing identity-enhancing resources to formerly homeless young people.

This impact and process evaluation aims to address critical gaps in the literature about transition-related supports by asking whether and how an identity capital intervention delivered outside the social service sector impacts the life-trajectories of formerly homeless young people. Particular attention will be paid to whether this intervention shows promise as an unconventional way to tackle poverty and improve social inclusion.

Specifically, this evaluation will investigate and disseminate important new knowledge on the following outcomes

  1. The impact of the intervention on measures of hope, community integration, social connectedness, and self-esteem.
  2. The effectiveness of the intervention to increase the number of young people in education, employment, or training.
  3. Understanding any practical challenges encountered during the intervention implementation and how these challenges were resolved.
  4. Understanding what young people found most beneficial about the intervention and their suggestions for how it could be improved.

An impact and process evaluation utilizing a mixed method prospective cohort design with an intervention and delayed intervention comparison group is the most appropriate because it:

  1. Addresses the crucial need to understand and disseminate evidence regarding the impact and process of interventions targeting homeless youth - both will help assess and inform questions related to scalability.
  2. Provides a more complete and synergistic utilization of data.
  3. Balances scientific rigor with the ethical principle of fairness.

This evaluation is a mixed-methods design with a strong qualitative component. Quantitative data collection will occur at six weeks pre-baseline (for the delayed intervention group only), baseline (immediately pre-intervention), immediately post-intervention (one week), three months post-intervention, six months post-intervention, and nine months post-intervention. At each data collection period, participants will be asked whether they are enrolled in education, employment, or training in the questionnaire. They will also be asked about their housing status. Hope, community integration, social connectedness, and self-esteem will be measured quantitatively using scales.

The frequencies, means and standard deviations will be calculated for all evaluation variables. To address the question about the extent to which the outcome variables change over time, independent t-tests will be conducted on the continuous variables (hope, community integration, social connectedness, and self-esteem) and chi-square tests on the categorical variables (education, employment, training, and housing) to report on changes between: 1) baseline and immediately post-intervention; 2) baseline and three months post-intervention; 3) baseline and six months post-intervention; and 4) baseline and nine months post-intervention. To address the question about whether the intervention group demonstrates a statistically significant difference in outcomes compared to no intervention, the outcome variables between the intervention group and the delayed intervention group will be compared six weeks after the baseline questionnaires (i.e., the intervention group will have just completed the dk Leadership program and the delayed intervention group will not have started it yet).

Qualitative measures are an important feature of this evaluation and will consist of: 1) participant observation and 2) focus groups.

Over the six-week intervention period, the co-investigator will attend the weekly meetings as an observer. She will do this with both the intervention and the delayed intervention group. During these meetings, the investigator will take field notes, documenting her perceptions about the way the workshops and group coaching sessions are being run, and how they are being 'taken up' by the young people in the intervention group.

Focus groups, will take place immediately (one week), three months, six months, and 9 months post-intervention. Participants in the intervention and delayed intervention will be in separate focus groups. The questions posed during the focus groups will be guided by the evaluation objectives, but will be conversational and exploratory in nature with particular attention to identity capital, life-trajectories, and social inclusion. It is anticipated that the focus groups will last 60 - 90 minutes. All will be conducted by the co-investigator at locations most convenient for the study participants, and will be audio recorded and transcribed verbatim.

In keeping with the emergent, iterative nature of research using a qualitative design, data analysis and interpretation will begin at the onset of the intervention. The handwritten field notes from the participant observation sessions will be typed into Microsoft Word by the co-investigator immediately after each biweekly meeting. The 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 meeting with the participants, the co-investigator will conduct a preliminary data analysis, reading the field notes multiple times, separating the data into coded segments, making analytic memos beside large portions of the field notes or transcripts, identifying emerging themes (and comparing/contrasting these between participants), and complying new questions to ask the participants. Participants 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 Dedoose39 will be utilized to assist with sorting and coding the qualitative data.

Study participants may benefit from the opportunity to share with the co-investigator and with each other about whether and how an identity-building intervention delivered outside the social service sector impacts their life-trajectories. Additionally, participants may derive satisfaction from knowing that their contributions will help advance understanding about how best to design interventions that help tackle poverty and improve social inclusion for young people transitioning out of homelessness.

Conditions
Youth, Homelessness
Being tested
dk Leadership
Keywords
Hopelessness, Self Esteem, Social Isolation, Employment Status, Education, Housing Problems, Identity, Social, Self Efficacy, Control Locus, Poverty, Youth, Homelessness, Homeless Youth
Medical subject headings
Social Isolation, Social Identification

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dk LeadershipBehavioural

    Participants will attend two full-day workshops and four half-day group coaching sessions over the course of six weeks. The workshops and coaching sessions will be supplemented by on-line (e.g., podcasts) and print (e.g., workbooks) material. The full-day workshops will focus on identity-enhancing topics such as self-understanding, creating a life of meaning and purpose, and strategic career development. The half-day group coaching sessions will focus on workshop debriefing and on exploring solutions to transition-related challenges faced by study participants. The program was designed and carried out by dk Leadership - an established leadership and executive coaching centre in Toronto, Canada.

Study groups in NCT03772522
Study groupRoleWhat they receive
Immediate dk Leadership InterventionExperimentalParticipants allocated to the immediate intervention group are assessed for study outcomes immediately prior to the 6-week dk Leadership intervention and immediately after the intervention. Outcomes measured immediately post-intervention are compared with participants who have not received the intervention during the 6 weeks. After the delayed intervention group takes the intervention, the two groups are joined into a single arm.
Receives: Behavioral: dk Leadership
Delayed dk Leadership InterventionPlacebo comparatorParticipants allocated to this arm receive 6 weeks of no intervention. Outcomes are measured immediately before and immediately after the 6 week period. The change in outcomes are compared with participants who have received the intervention during the 6 week period. This group then receives the same dk Leadership intervention; after this point, the two groups are joined into a single arm for subsequent analyses.
Receives: Behavioral: dk Leadership

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Change From Baseline in Hopelessness as Measured by the Beck Hopelessness Scale

    Assessed using Beck's Hopelessness Scale, a 20-item scale which measures motivation, expectations, and feelings about the future (internal consistency α = .93). The total scoring range is 0-20, with 0-3 = no or minimal hopelessness, 4-8 = mild hopelessness, 9-14 = moderate hopelessness- requires monitoring, and 15+ = severe hopelessness- suicide risk.

    Participants' scores at baseline will be compared with their scores post-intervention to detect changes in levels of hopelessness. The change in scores over time will describe the general trajectory of hopelessness.

    Measured: Assessed at 6 weeks pre-baseline (for the delayed intervention group only), at baseline (immediately pre-intervention), immediately post-intervention, 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention

  2. Mean Change From Baseline in Community Integration (Psychological and Physical) Scores as Measured by the Community Integration Scale (CIS)

    Assessed using the Community Integration Scale, an 11-item scale which measures behavioural (e.g., participation in activities) and psychological (e.g., sense of belonging) aspects of community integration. The CIS includes a physical subscale (with scores ranging from 0-7) and a psychological subscale (with scores ranging from 4-20). Higher scores indicate greater community integration. This scale was used extensively in the Chez Soi/At Home study, but psychometric properties have yet to be reported.

    Participants' scores at baseline will be compared with their scores post-intervention to detect changes in levels of community integration. The change in scores over time will describe the general trajectory of community integration.

    Measured: Assessed at 6 weeks pre-baseline (for the delayed intervention group only), at baseline (immediately pre-intervention), immediately post-intervention, 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention

  3. Mean Change From Baseline in Social Connectedness Scores as Measured by the Social Connectedness Scale (SCS)

    Measured using the Social Connected Scale, a 20-item scale which measures belongingness - the degree to which people feel connected to others (internal consistency α = .92). Scores range from 20-120, with higher scores indicating greater social connectedness.

    Participants' scores at baseline will be compared with their scores post-intervention to detect changes in social connectedness. The change in scores over time will describe the general trajectory of social connectedness.

    Measured: Assessed at 6 weeks pre-baseline (for the delayed intervention group only), at baseline (immediately pre-intervention), immediately post-intervention, 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention

  4. Mean Change From Baseline in Self-esteem Scores as Measured by the Rosenberg Self-Esteem Scale (RSS)

    Assessed using the Rosenberg Self-Esteem Scale, a 10-item scale which measures of global self-worth (internal consistency α = .77 - .88). Scores range from 0-30. A score of <15 is categorized as low self-esteem, and 15-30 is categorized as normal self-esteem.

    Participants' scores at baseline will be compared with their scores post-intervention to detect changes in self-esteem. The change in scores over time will describe the general trajectory of self-esteem.

    Measured: Assessed at 6 weeks pre-baseline (for the delayed intervention group only), at baseline (immediately pre-intervention), immediately post-intervention, 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention

Secondary outcomes (5)
  1. Change in Vocational Participation/Employment as Assessed by a Questionnaire From Baseline to 9-Months

    Acquirement of meaningful employment will be assessed. Participants will be prompted to answer questions about their current employment status, intensity of employment, and type of employment in the questionnaire. The change in the number of participants engaging in employment over time at the aggregate level will be assessed.

    Measured: Assessed at baseline (immediately pre-intervention) and 9 months post-intervention

  2. Change in Academic Participation/Educational Attainment as Assessed by a Questionnaire From Baseline to 9-Months

    Participants will be prompted to answer questions about their current educational pursuit, and type of schooling or training program in a questionnaire. The change in the number of participants engaging in education over time on the aggregate will be assessed.

    Measured: Assessed at baseline (immediately pre-intervention) and 9 months post-intervention

  3. Number of Themes Related to Change in Career Awareness Informed by Focus Groups With Participants

    This outcome will describe the general trajectory of career awareness. Self-awareness, confidence, ability to articulate career goals, and understanding of how to achieve career goals will be assessed in focus groups. The questions posed during the focus groups will be guided by the evaluation objectives, but will be conversational and exploratory in nature with particular attention to identity capital, life-trajectories, and social inclusion. All will be conducted by the co-investigator at locations most convenient for the study participants, and will be audio recorded and transcribed verbatim. All focus groups will be analyzed together; the themes identified from the analysis will be presented as one data entry.

    Measured: 60 - 90 minute focus groups at each of the following timepoints: immediately post-intervention, 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention

  4. Number of Themes Related to Change in Knowledge and Use of Soft Skills Informed by Focus Groups With Participants

    Acquirement of soft skills such as motivation, goal setting, self-discipline, and organization will be assessed in focus groups. The questions posed during the focus groups will be guided by the evaluation objectives, but will be conversational and exploratory in nature with particular attention to identity capital, life-trajectories, and social inclusion. All will be conducted by the co-investigator at locations most convenient for the study participants, and will be audio recorded and transcribed verbatim. All focus groups will be analyzed together; the themes identified from the analysis will be presented as one data entry.

    Measured: 60 - 90 minute focus groups at each of the following timepoints: immediately post-intervention, 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention

  5. Number of Themes Related to Participant Perspectives of Intervention Barriers and Facilitators, as Informed by Focus Groups With Participants

    In focus groups, youth will be prompted to discuss the strengths and drawbacks of conventional programs for youth transitioning out of homelessness. These evaluations will be compared to this intervention to determine what aspects of programs youth find most helpful, and which could be improved upon. The questions posed during the focus groups will be guided by the evaluation objectives, but will be conversational and exploratory in nature with particular attention to identity capital, life-trajectories, and social inclusion.All will be conducted by the co-investigator at locations most convenient for the study participants, and will be audio recorded and transcribed verbatim. All focus groups will be analyzed together; the themes identified from the analysis will be presented as one data entry.

    Measured: 60 - 90 minute focus groups at each of the following timepoints: immediately post-intervention, 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2018
  2. Study start1 Apr 2018
  3. Primary completion6 Aug 2019
  4. Study completion6 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Thirty young people (aged 18 - 26 years) who have transitioned out of homelessness within the past three years will be offered scholarships to participate in a six-week intervention that focuses on building identity capital and providing career direction. The intervention will be designed and carried out by dk Leadership - an established, highly successful leadership and counseling centre in Toronto with a track record of significantly improving the life trajectories of teens and adults. Importantly, study participants will be incorporated into the centre's current programming, meaning the intervention will be held at a location not associated with homelessness. All of the participants will be invited to attend two focus groups, which will be conducted immediately post-intervention and at six months post-intervention. Each focus group will contain approximately 8 - 10 youth. Participants in the intervention and delayed intervention will be in separate focus groups.
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03772522
Sponsor's protocol ID
18-002
Acronym
TIP
Status last verified
Jun 2023
First submitted
23 Sep 2018
Last updated
22 Jun 2023
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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., & 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

  • 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

  • Covenant House Toronto. (2016). Facts and stats. Retrieved from http://www.covenanthousetoronto.ca/homeless-youth/Facts-and-Stats

  • 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/s10560-015-0424-2

  • 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

  • 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

  • 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.

    PubMed 29981071
  • 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.

    PubMed 20494240
  • Coren E, Hossain R, Pardo JP, Veras MM, Chakraborty K, Harris H, Martin AJ. Interventions for promoting reintegration and reducing harmful behaviour and lifestyles in street-connected children and young people. Evid Based Child Health. 2013 Jul;8(4):1140-272. doi: 10.1002/ebch.1923.

    PubMed 23877940
  • 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.

    PubMed 25390579
  • 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

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

  • 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

  • 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. doi: 10.1111/j.1532-7795.2009.00610.x.

    PubMed 25067896

Questions about this trial

What is this clinical trial studying?

A study testing dk Leadership in people with Youth and Homelessness, run by Unity Health Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change From Baseline in Hopelessness as Measured by the Beck Hopelessness Scale (time frame: Assessed at 6 weeks pre-baseline (for the delayed intervention group only), at baseline (immediately pre-intervention), immediately post-intervention, 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03772522, which also lists 37 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023; AzTrials last refreshed its copy on 27 Oct 2026.

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