Well-being of Shelter Guests in Vancouver

Efficacy, Self Clinical Trial

Official title:

Well-being of Shelter Guests in Vancouver

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03524495
• Other study ID #: H18-00047
• Status: Recruiting
• Phase: N/A
• Start date: March 5, 2018
• Est. completion date: June 2019

Study information

• Verified date: May 2018
• Source: University of British Columbia
• Contact: Ryan Dwyer
• Phone: 604-822-2755
• Email: ryandwyer[@]psych.ubc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will primarily investigate the impacts of a one-time unconditional cash transfer on the well-being of recently homeless individuals.

Secondary research questions will examine the impact of personal coaching for cash recipients and the impact of a workshop and coaching intervention for non-cash recipients.

Description:

The goal of this project is to examine the effect of a direct cash transfer intervention involving recently homeless people in Metro Vancouver. In partnership with the New Leaf Project, the investigators will distribute a one-time unconditional cash grant of $7,500 to 50 participants. An additional seventy five participants will serve as a control group and will not receive the cash transfer. Some participants will receive supplementary affirmational workshops and/or professional coaching. Participants will be followed up one month after baseline and then again every three months for 12 months to evaluate the effect of the cash transfer, workshop, and coaching interventions. Over the course of the study, the investigators will assess participants' cognitive functioning, subjective well-being, and self-efficacy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: June 2019
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age - Participants must be between the ages of 19 and 65

• Length of Time Homeless - Participants must be homeless for two calendar years or less.

• Employability - Project participants must be able / eligible to gain full-time employment in the near future (i.e., Canadian citizen or permanent resident)

Exclusion Criteria:

• Severity of Substance Use - Participants scoring = 6 on the Drug Abuse Screening Test (DAST-10) will be excluded.

• Severity of Alcohol Use - Participants scoring within the problematic range (i.e., = 20) on the Alcohol Use Disorders Identification Test (AUDIT) will be excluded.

• Severity of Psychiatric Symptoms -Participants scoring = 3 on item 5, or scoring > 4 on items 13 or 14 of the Colorado Symptom Index (CSI) will be excluded.

• Participants will be excluded if they indicate that receiving a lump sum of around $8000 would have negative impacts on their life.

Related Conditions & MeSH terms

• Cognitive Function 1, Social
• Efficacy, Self
• Satisfaction, Personal

Intervention

Behavioral:
• Cash transfer
Participants will receive a one-time unconditional cash transfer of $7,500.
• Workshop
Participants will complete a workshop involving self-affirmation and personal planning exercises.
• Coaching
Participants will complete at least 1 one-on-one coaching session with a personal coach. Participants may complete as many as 3 sessions a month for 6 months (free of charge).

Locations

Country	Name	City	State
Canada	New Leaf Project	Vancouver	British Columbia

Sponsors (5)

Lead Sponsor	Collaborator
University of British Columbia	Government of Canada, Mitacs, New Leaf Project, U.S. National Science Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Satisfaction with Life	Satisfaction with Life will be measured using the 5-item Satisfaction with Life Scale. Items will be rated on a Likert scale from 1 (Strongly disagree) to 7 (Strongly agree). The items will be averaged to form a composite score. Multiple imputation will be used to account for missing data. Higher scores indicate a better outcome.; This measure will be assessed at each time point during the study, but confirmatory analyses will only be conducted from Baseline to 1-month. Analyses conducted at other time points will be considered exploratory.	Baseline to 1-month
Primary	Positive Affect	Positive affect will be measured using the 6 positive emotions from the 12-item Schedule of Positive and Negative Experience Scale. Items will be rated on a Likert scale from 1 (Very rarely or never) to 5 (Very often or always). The items will be averaged to form a composite score. Multiple imputation will be used to account for missing data. Higher scores indicate a better outcome.; This measure will be assessed at each time point during the study, but confirmatory analyses will only be conducted from Baseline to 1-month. Analyses conducted at other time points will be considered exploratory.	Baseline to 1-month
Primary	Negative Affect	Negative affect will be measured using the 6 negative emotions from the 12-item Schedule of Positive and Negative Experience Scale. Items will be rated on a Likert scale from 1 (Very rarely or never) to 5 (Very often or always). The items will be averaged to form a composite score. Multiple imputation will be used to account for missing data. Lower scores indicate a better outcome.; This measure will be assessed at each time point during the study, but confirmatory analyses will only be conducted from Baseline to 1-month. Analyses conducted at other time points will be considered exploratory.	Baseline to 1-month
Primary	Subjective Well-being	A composite score will be computed by first standardizing scores of satisfaction with life, positive affect, and negative affect (reverse-coded), and then averaging these three standardized scores for each participant. Higher scores indicate a better outcome.; This measure will be assessed at each time point during the study, but confirmatory analyses will only be conducted from Baseline to 1-month. Analyses conducted at other time points will be considered exploratory.	Baseline to 1-month
Primary	Fluid Intelligence	Fluid intelligence will be measured using 10 Raven's Standard Progressive Matrices. The accuracy (the number of items answered correctly divided by the total number of items) is the primary measurement. Items that are skipped or declined will be treated as incorrect answers. Higher scores indicate a better outcome.; This measure will be assessed at each time point during the study, but confirmatory analyses will only be conducted from Baseline to 1-month. Analyses conducted at other time points will be considered exploratory.	Baseline to 1-month
Primary	Executive Function (accuracy)	Executive function will be measured using 12 trials of a visual Stroop task. Participants will be asked to click a button on the same side of the screen when image A appears, but the opposite side of the screen when image B appears. There are 6 congruent trials and 6 incongruent trials. Trials will be presented in random order.; Executive function will be assessed in two ways. The first measure is accuracy (the number of items answered correctly divided by the total number of items). Higher scores indicate a better outcome.; This measure will be assessed at each time point during the study, but confirmatory analyses will only be conducted from Baseline to 1-month. Analyses conducted at other time points will be considered exploratory.	Baseline to 1-month
Primary	Executive Function (efficiency)	Executive function will be measured using 12 trials of a visual Stroop task. Participants will be asked to click a button on the same side of the screen when image A appears, but the opposite side of the screen when image B appears. There are 6 congruent trials and 6 incongruent trials. Trials will be presented in random order.; Executive function will be assessed in two ways. The second measure is an efficiency score (the accuracy divided by the mean reaction time (RT) of correct trials). We will remove the participant if their mean RT is 3 standard deviations away from the mean RT of the sample at that time point. Higher scores indicate a better outcome.; This measure will be assessed at each time point during the study, but confirmatory analyses will only be conducted from Baseline to 1-month. Analyses conducted at other time points will be considered exploratory.	Baseline to 1-month
Primary	Self-efficacy	Self-efficacy will be measured using the 10-item General Self-Efficacy Scale. Items will be rated on a Likert scale from 1 (Not at all true) to 4 (Exactly true). The items will be averaged to form a composite score. Multiple imputation will be used to account for missing data. Higher scores indicate a better outcome.; This measure will be assessed at each time point during the study, but confirmatory analyses will only be conducted from Baseline to 1-month. Analyses conducted at other time points will be considered exploratory.	Baseline to 1-month