Adaptation of Critical Time Intervention for Young Adults With MH Challenges (CTI-YAMH)

Adaptation of Critical Time Intervention for Young Adults With Mental Health Challenges in the Transition From Homelessness to Housing

Young adults experiencing homelessness have high rates of mental health conditions but low rates of service utilization and the point of transition from homelessness to supported housing provides a window of opportunity for intervention. The goal of this study is to adapt the evidenced-based intervention, Critical Time Intervention, for young adults with mental health conditions who are entering a rapid rehousing program and test the adapted intervention in a randomized feasibility pilot trial. Participants in the pilot trial will be asked to participate in the CTI-YAMH intervention that involves structured case management and supports from a mental health liaison and a peer support specialist. After a pilot feasibility phase (n=8), we will test the intervention by randomly assigning young adults on the housing wait list to a housing program with CTI-YAMH (n=26) or to get housing supports from another agency that does not provide CTI-YAMH (treatment as usual, n=26).

Study Overview

• Status: Recruiting
• Conditions: Mental Disorder
• Intervention / Treatment: Behavioral: Critical Time Intervention for Young Adults with Mental Health conditions

Detailed Description

The design of the phased open trial allows for us to test and further refine our intervention procedures, then include this learning in a randomized feasibility pilot. This will enable us to examine several issues that we anticipate will need refinement prior to larger testing in a fully powered future large study. Our sample (n=60) will include young adults (age 18-24) who have qualified for RRH supports. Entry into the homelessness system is managed through a coordinated access system with a consistent assessment process and centralized wait list which is prioritized based on a screener that asks respondents to self-report whether they have been diagnosed with a mental disorder. Young adults are assigned to a RRH case manager based on capacity across agencies that provide RRH including Covenant House TExas (CHT). CTI-YAMH targets young adults with mental health symptoms and will be implemented at CHT. The screening tool used to prioritize assignment to housing asks for a self-report of mental health symptoms as well as other risk factors that give a housing priority score. When CHT has capacity for a new youth, we will work with the coordinated access system to match and enroll two young adults with similar priority scores into our study after screening for mental health symptoms, then randomize one to CHT and one to another agency providing young adult RRH with capacity (TAU). We will closely track the feasibility of this real-world process, keeping track of the number of YAEH who are on the waiting list, number contacted, number successfully enrolled, and number that meet our enrollment criteria. For this study, we will partner with CHT which currently employs three RRH case managers who each carry a caseload of 18 young adults.

For the first phase of the open trial, we aim to recruit and enroll a sample of 8 participants. We anticipate this will take approximately 3 months which will enable us to refine our enrollment procedures and finalize intervention procedures. After 6 months we will move into the next phase. For the second phase of the open trial, we aim to recruit a sample of 52 young adults, 26 for each condition over the course of the 12-month period. Across the community, the average length of stay in RRH is 12 months so without accounting for likely expansion, we anticipate that there will be approximately 4-5 intakes per month for the CHT RRH program at current size. Given the new focus on young adults in the community and potential expansion of RRH services at CHT, we expect that this number will increase as services ramp up. Based on our prior research, we estimate that 60-75% will screen positive for mental health problems as assessed with the Kessler-6 so at current capacity we would identify 3-4 participants per month that are eligible for the study and enroll 2-3 of these for approximately 12 months in the intervention condition and 2-3 participants per month for 12 months in the TAU condition..condition.

Enrollment and Data Collection Procedures. For both phases, young adults (age 18-24) on the housing eligibility list will be screened for study criteria (meeting criteria for psychological distress on Kessler-6 [74] or self-reported prior diagnosis of depression, anxiety, bipolar or a psychotic disorder with ongoing symptoms) and invited to participate at the point of assignment to RRH. Young adults will be told of the opportunity to participate in the study at the time of eligibility assessment for housing and asked for permission to provide their names to the study team if interested. For the first phase we will attempt to enroll all those assigned to RRH at CHT who meet our criteria. For the second phase, when housing is about to be assigned for CHT, we will attempt to enroll two similar young people and assign one to CHT and one to TAU. For both phases 1 and 2, we will contact young people about their interest, then schedule a baseline interview to be held over zoom or by phone lasting approximately one hour. Interviewers will obtain informed consent electronically signed through DocuSign and administer the survey via phone or zoom with each meeting lasting approximately one hour. This format enables us to be flexible and responsive in scheduling interviews. If participants do not have access to a phone or zoom, researchers have the ability to meet clients in the agency where they individual is connected to a case manager. In order to track outcomes through the course of the 6-month intervention, research assistants we will administer surveys at baseline, the midpoint (3 months), end of the intervention (6 months) and 6 month6-month follow-up (12 months). Survey data at each measurement point will be collected on tablets using a questionnaire programmed in Qualtrics. For those in phase 1, we will also conduct qualitative interviews (n=8) and will also interview each of the professionals involved in implementing it (n=5) to explore qualitatively how the intervention activities hit the hypothesized targets of the intervention and allow the potential for other key mechanisms to emerge as well as assess implementation outcomes of acceptability and appropriateness. Qualitative interviews will be conducted using a semi-structured interview guide and will be digitally recorded, then transcribed. If participants do not want to be recorded, detailed notes will be taken.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alicia Vargas; Phone Number: 713-743-9215; Email: avargas2@uh.edu
• Study Contact Backup: Name: Yadira Cortez; Phone Number: 713-743-5571; Email: ycortez2@central.uh.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77006
      • Recruiting
      • Covenant House Texas
      • Contact: Alan Prince, MPA; Phone Number: 713-523-2231; Email: aprince@covenanthouse.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Young adults (age 18-24) on the housing eligibility list assigned to rapid rehousing
• Positive for psychological distress on Kessler-6 or self-reported prior diagnosis of depression, anxiety, bipolar or a psychotic disorder with ongoing symptoms

Exclusion Criteria:

• Age 25 or older
• Not English speaking
• No eligible for rapid rehousing based on housing priority score

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Condition, CTI-YAMH; Participants receive the CTI-YAMH intervention in conjunction with rapid rehousing supports for the 6 month intervention	Behavioral: Critical Time Intervention for Young Adults with Mental Health conditions; SIx month supportive intervention involving CTI phased based casemanagement, support from a peer support specialist, and support from a mental health liaison
No Intervention: Treatment as Usual Condition; Participants will be assigned to a housing program at another agency that provides rapid rehousing with usual supports

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Housing Stability	Housing Security Scale Number of days homeless, Number of moves in prior 90 days	Baseline, 3 mo, 6 mo, 12 mo
Mental Disorder	Diagnosis of Common Disorders i.e. Depression, Anxiety, Bipolar, Psychotic Disorders	Baseline, 12 mo.
Depressive Symptoms	PHQ-9	Baseline, 3 mo, 6mo, 12 mo.
Anxiety Symptoms	GAD-7	Baseline, 3 mo, 6mo, 12 mo.
PTSD Symptoms	Primary Care PTSD Screen	Baseline, 3 mo, 6mo, 12 mo.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Engagement	Self-report of taking medication, attending appointments; Client Engagement in Child Protective Services Scale, modified for mental health services	Baseline, 3 mo, 6mo, 12 mo.

Collaborators and Investigators

• Sponsor: University of Houston

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2023
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): November 30, 2025

Study Registration Dates

• First Submitted: October 20, 2023
• First Submitted That Met QC Criteria: October 20, 2023
• First Posted (Actual): October 26, 2023

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 20, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: R34MH129542-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be uploaded to the NIMH NDA using GUID identifiers
• IPD Sharing Time Frame: in accordance with data sharing requirements for NIMH
• IPD Sharing Access Criteria: Institutional level through the NDA
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No