NCT03277794

Brief Summary

This project builds upon initial proof of concept work examining the optimal set of supports for youth who have recently exited homelessness - an intervention comprised of mental health and peer supports alongside transitional case management. This collaborative model will be tested as a proof-of-concept in Thunder Bay with Indigenous youth and a trial will be conducted in Toronto to optimize and determine the effectiveness of the existing model of support.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2017

Completed
28 days until next milestone

First Posted

Study publicly available on registry

September 11, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

February 23, 2021

Completed
Last Updated

March 18, 2021

Status Verified

February 1, 2021

Enrollment Period

1.8 years

First QC Date

August 14, 2017

Results QC Date

August 11, 2020

Last Update Submit

February 24, 2021

Conditions

Outcome Measures

Primary Outcomes (5)

  • Housing

    Participants coded in a binary manner as having gained or sustained housing (binary positive) or lost (binary negative) based on assessment of the participant's trajectory from baseline to 6 months.

    Change from Baseline to 6 months

  • Employment/Education

    Participants coded in a binary manner as having gained or sustained education or employment (binary positive) or lost (binary negative) based on assessment of the participant's trajectory from baseline to 6 months.

    Change from baseline to 6 months

  • Mental Health

    Participants coded in a binary manner as having gained or sustained mental health status without crises (binary positive) or experienced a crises that impacted major life domains (binary negative) based on assessment of the participant's trajectory from baseline to 6 months.

    Change from baseline to 6 months

  • Housing Security Scale

    The Housing Security Scale contains 12 items on a 5 point likert scale (Frederick et al., 2014). Scores range from "strongly disagree" (minimum = 1) to "strongly agree" (maximum = 5). Higher scores indicate better outcomes. Mean item range is 1-5 with pre-post difference reported.

    Change from Baseline to 6 months

  • Housing Security Scale (Subjective Housing Stability Subscale)

    The Housing Security Scale contains a 4 item subscale that measures subjective housing satisfaction and perception of housing stability (Frederick et al., 2014). Scores range from "strongly disagree" (minimum = 1) to "strongly agree" (maximum = 5). Higher scores indicate better outcomes with a mean range of 1-5 with pre-post change reported.

    Change from Baseline to 6 months

Secondary Outcomes (9)

  • Mental Health Continuum - Short Form

    Change from baseline to 6 month

  • Cognitive and Affective Mindfulness Scale

    Change from baseline to 6 months

  • Community Integration Scale

    Change from baseline to 6 months

  • Community Integration Measure

    Change from baseline to 6 months

  • Resilience Scale

    Change from baseline to 6 months

  • +4 more secondary outcomes

Study Arms (2)

Transitional Case Management Only

ACTIVE COMPARATOR

Participants in this arm will be provided with a transition-focused community support worker who will assist in areas ranging from general support and encouragement to assistance in navigating relevant systems. They will have weekly contacts with participants by phone, informal contact via text and email, and at least twice per month will visit the participant where they are residing. It is expected that all participants will engage a community support worker. The transitional case manager hired into this role will be highly experienced in case management for youth.

Behavioral: Transitional Case Management Only

Full HOP-C Service

EXPERIMENTAL

Service provision will be provided by Loft and Covenant House for the transitional case management component, the peer component will be supported through Sketch Arts, and the mental health component will be provided by a post-doctoral fellow clinical psychologist and a mindfulness therapist from the Centre for Mindfulness Studies, supervised by Dr. Sean Kidd.

Behavioral: HOP-C

Interventions

HOP-CBEHAVIORAL

Service provision will be provided by Loft and Covenant House for the transitional case management component, the peer component will be supported through Sketch Arts, and the mental health component will be provided by a post-doctoral fellow clinical psychologist and a mindfulness therapist from the Centre for Mindfulness Studies, supervised by Dr. Sean Kidd.

Full HOP-C Service

Participants in this arm will be provided with a transition-focused community support worker who will assist in areas ranging from general support and encouragement to assistance in navigating relevant systems. They will have weekly contacts with participants by phone, informal contact via text and email, and at least twice per month will visit the participant where they are residing. It is expected that all participants will engage a community support worker. The transitional case manager hired into this role will be highly experienced in case management for youth.

Transitional Case Management Only

Eligibility Criteria

Age16 Years - 26 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • between the ages of 16 and 26
  • have obtained secure housing in a time period up to 12 months previously

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

Location

Related Publications (45)

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  • Kidd SA, Vitopoulos N, Frederick T, Leon S, Wang W, Mushquash C, McKenzie K. Trialing the feasibility of a critical time intervention for youth transitioning out of homelessness. Am J Orthopsychiatry. 2020;90(5):535-545. doi: 10.1037/ort0000454. Epub 2020 Apr 20.

Related Links

Limitations and Caveats

Variability in youth service need resulting in variable effectiveness of treatment. In attempt to normalize the control group, it became less generalizable. RCT challenges with engagement and trust.

Results Point of Contact

Title
Dr. Sean Kidd
Organization
Centre for Addiction and Mental Health

Study Officials

  • Sean A Kidd, Phd

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinician Scientist

Study Record Dates

First Submitted

August 14, 2017

First Posted

September 11, 2017

Study Start

April 1, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

March 18, 2021

Results First Posted

February 23, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations