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Mental DisorderCTI-YAMHNCT06102850

Adaptation of Critical Time Intervention for Young Adults With MH Challenges

A study testing Critical Time Intervention for Young Adults with Mental Health conditions in people with Mental Disorder, run by University of Houston at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 24 yearsHealthy volunteers can take part
Conditions the study is for
Mental Disorder
What is being tested?
Critical Time Intervention for Young Adults with Mental Health conditions
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
5 Sep 2023to 30 Nov 2025
Phase
Interventional
Are there results?
None posted in the registry

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 24 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Alicia Vargas contact

713-743-9215

avargas2@uh.edu

United States1 site, 1 recruiting
  • Covenant House Texas

    Houston, Texas, 77006

    Alan Prince, MPA, 713-523-2231, aprince@covenanthouse.org

    Recruiting

Other trials in United States

About this study

Official title: 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).

Read the 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.

Conditions
Mental Disorder
Being tested
Critical Time Intervention for Young Adults with Mental Health conditions
Medical subject headings
Mental Disorders

What participants receive

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

  • Critical Time Intervention for Young Adults with Mental Health conditionsBehavioural

    SIx month supportive intervention involving CTI phased based casemanagement, support from a peer support specialist, and support from a mental health liaison

Study groups in NCT06102850
Study groupRoleWhat they receive
Intervention Condition, CTI-YAMHExperimentalParticipants receive the CTI-YAMH intervention in conjunction with rapid rehousing supports for the 6 month intervention
Receives: Behavioral: Critical Time Intervention for Young Adults with Mental Health conditions
Treatment as Usual ConditionNo interventionParticipants will be assigned to a housing program at another agency that provides rapid rehousing with usual supports

What is being measured

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

  1. Housing Stability

    Housing Security Scale Number of days homeless, Number of moves in prior 90 days

    Measured: Baseline, 3 mo, 6 mo, 12 mo

  2. Mental Disorder

    Diagnosis of Common Disorders i.e. Depression, Anxiety, Bipolar, Psychotic Disorders

    Measured: Baseline, 12 mo.

  3. Depressive Symptoms

    PHQ-9

    Measured: Baseline, 3 mo, 6mo, 12 mo.

  4. Anxiety Symptoms

    GAD-7

    Measured: Baseline, 3 mo, 6mo, 12 mo.

  5. PTSD Symptoms

    Primary Care PTSD Screen

    Measured: Baseline, 3 mo, 6mo, 12 mo.

Secondary outcomes (1)
  1. Treatment Engagement

    Self-report of taking medication, attending appointments;

    Client Engagement in Child Protective Services Scale, modified for mental health services

    Measured: Baseline, 3 mo, 6mo, 12 mo.

Timeline

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

  1. First posted26 Oct 2023
  2. Study start5 Sep 2023
  3. Primary completion31 Jan 2025 (estimated)
  4. Study completion30 Nov 2025 (estimated)

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study includes a phased open trial, first using a single group feasibility pilot (n=8) to refine the intervention manuals, then employed a randomized parallel feasibility pilot (n=26 in each group)
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06102850
Sponsor's protocol ID
R34MH129542-01A1
Acronym
CTI-YAMH
Status last verified
Oct 2023
First submitted
20 Oct 2023
Last updated
26 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data will be uploaded to the NIMH NDA using GUID identifiers

Publications

  • Narendorf SC, Munson MR, Khan U, Brown M, Gomez G, Santa Maria D, Gilmer T, Gattis MN, Hayward P, Herman D. Study protocol for a feasibility evaluation of Charge Up!: an adaptation of Critical Time Intervention for young adults moving from homelessness to housing. Pilot Feasibility Stud. 2025 Jul 2;11(1):91. doi: 10.1186/s40814-025-01677-7.

    PubMed 40605122

Questions about this trial

What is this clinical trial studying?

A study testing Critical Time Intervention for Young Adults with Mental Health conditions in people with Mental Disorder, run by University of Houston at 1 site in United States.

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 2 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: status not confirmed, as of the sponsor's last update on 26 Oct 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 United States. 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. 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?

Results are not available in the source record.

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

Contact Alicia Vargas (713-743-9215, avargas2@uh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Housing Stability (time frame: Baseline, 3 mo, 6 mo, 12 mo). The study lists 5 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 NCT06102850, which also lists 1 linked publication.

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 26 Oct 2023.

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