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Psychosis Nos/OtherPhase 1NCT04314635

A Treatment Engagement Protocol for Psychiatrically Hospitalized Adolescents at Clinical High Risk for Psychosis

A Phase 1 study testing Brief family engagement intervention for CHR and Treatment as usual (TAU) in people with Psychosis Nos/Other, run by Rhode Island Hospital 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The current study explores the development and use of a family engagement intervention for psychiatrically hospitalized adolescents with emerging psychosis symptoms. The program is designed to increase understanding of mental health symptoms and promote motivation for engagement in outpatient services. Read more about this study

Who is it for?
Ages 13 to 18 years
Conditions the study is for
Psychosis Nos/Other
What is being tested?
Brief family engagement intervention for CHR and Treatment as usual (TAU)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited States
Study dates
29 Jun 2020to 30 Nov 2023
Phase
Phase 1
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 13 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • ages 13-18
  • must meet criteria for a clinical high risk (CHR) syndrome based on the Structured Interview for Psychosis-risk Syndromes
  • IQ > or = 70 as determined by the Wechsler Abbreviated Scales of Intelligence, Second Edition (WASI-II)
  • ability to communicate in English

Who cannot join

  • parent characteristics (inability to communicate in English, suspected intellectual impairment, or acute symptomatology) that interferes with parent's comprehension of study procedures and informed consent documents
  • teen's acute symptomatology that may interfere with their comprehension of study procedures and/or ability to complete interviews, assessments and/or intervention (clinical judgment will be used to determine assent/participation eligibility on a case-by-case basis)
  • teen's intellectual disability (IQ < 70) as determined by the WASI-II
  • teen meets criteria for a full threshold psychotic disorder (i.e. schizophrenia, schizoaffective disorder)

Trial locations and contacts

1 site in 1 country.

Elizabeth Thompson, PhD contact

401-432-1617

elizabeth_thompson@brown.edu

United States1 site, 1 recruiting
  • Bradley Hospital

    East Providence, Rhode Island, 02915

    Elizabeth Thompson, PhD, elizabeth_thompson@brown.edu

    Recruiting

Other trials in United States

About this study

Official title: A Treatment Engagement Protocol to Improve Follow-Up Care for Psychiatrically Hospitalized Adolescents at Clinical High Risk for Psychosis

The current study explores the development and use of a family engagement intervention for psychiatrically hospitalized adolescents with emerging psychosis symptoms. The program is designed to increase understanding of mental health symptoms and promote motivation for engagement in outpatient services. Findings from this study may inform ways to effectively educate and engage youth at clinical high risk for psychosis, and their families, in treatment that may be critical for improving future functioning and outcomes.

Read the detailed description

Many individuals who develop psychotic disorders report having experienced subthreshold psychosis (i.e., clinical high risk-CHR- symptoms) in adolescence, prior to full-threshold symptoms. The emergence of symptoms during this critical stage of maturation can cause a great deal of distress and disruption, oftentimes leading to long-term illness and functional impairment. Evidence supporting the benefits of psychosocial treatment, particularly family-oriented team-based approaches, for young people in the early stages of psychosis has inspired ongoing efforts to identify symptoms as early as possible. Identification and service engagement can facilitate risk monitoring, and early treatment (for psychosis and/or co-occurring concerns) maximizes recovery and minimizes the negative sequelae of illness. Given that many CHR youth seek help for a variety of mental health concerns prior to the emergence of full psychosis, often through emergency services, and many do not disclose psychosis-spectrum symptoms spontaneously, targeted CHR assessment and intervention within a general psychiatric population is important.

The purpose of this study is to identify psychiatrically hospitalized teens who present with new onset CHR symptoms and pilot, via a randomized trial, a brief intervention to enhance outpatient treatment engagement post-hospitalization. The intervention will directly target three mechanisms linked to service use: mental health literacy, attitudes toward treatment, and family partnership (i.e. family involvement and co-engagement in treatment). In the experimental group, teens and caregivers will participate in a brief intervention informed by existing evidence-based treatment protocols. The proposed intervention will include three modules: 1) assessment of psychosis-risk symptoms and treatment attitudes and barriers, 2) an evidence-based psychoeducation module designed for young people with psychosis-risk syndromes and their families, and 3) an empirically-supported motivational enhancement protocol developed for teens and parents to increase outpatient service use after hospital discharge.

The investigators will first pilot the intervention with parent-teen dyads (n = 20-30) using an iterative approach to refine the content and delivery. To inform intervention development, post-intervention session evaluations and qualitative exit interviews will be used to explore attitudes and opinions regarding intervention content and delivery. After this development phase, the investigators will conduct a randomized open trial comparing treatment-as-usual (TAU) to TAU + the experimental intervention (n = 80 dyads). TAU includes standard care modules (psychoeducation, coping, safety planning, problem solving, healthy lifestyle) administered to the teen. All teens, as part of TAU, also receive skills groups, individual treatment, and family planning meetings. Additionally, all enrolled families (experimental and TAU) will receive a referral to an outpatient provider for psychosocial treatment (standard care procedure) plus referral to specialized CHR case management services. Case management, if elected, will be provided through the local coordinated specialty care (CSC) psychosis-risk clinic, which offers empirically-supported team-based services including case monitoring, consultation to outside providers, and group and family treatment. Primary outcomes, measured at 1- and 3-month follow-ups, include the engagement of the purported therapeutic mechanisms (i.e. mental health literacy, attitudes toward treatment, family partnership). Secondary outcomes include outpatient service use and rates of enrollment in CSC case management services across groups.

Being tested
Brief family engagement intervention for CHR, Treatment as usual (TAU)
Keywords
clinical high risk (CHR)

What participants receive

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

  • Brief family engagement intervention for CHRBehavioural

    The individual sessions, done with the caregiver and the teen separately, include a review of symptoms and a qualitative interview exploring treatment priorities, attitudes, and perceived barriers. The first family session focuses on psychoeducation. The second family session focuses on motivational enhancement, to promote ongoing engagement in services after discharge, including outpatient treatment and case management through the CSC.

  • Treatment as usual (TAU)Behavioural

    The TAU group will receive treatment as usual on the adolescent inpatient unit. This includes individual therapy, psychiatric care, skills groups, and family therapy meetings.

Study groups in NCT04314635
Study groupRoleWhat they receive
TAU comparison groupActive comparatorTAU includes standard care modules (psychoeducation, coping, safety planning, problem solving, healthy lifestyle) administered to the teen while they are hospitalized on the inpatient unit. All teens, as part of TAU, also receive skills groups, individual treatment, and family planning meetings. All TAU families will receive a referral to an outpatient provider (standard care procedure) plus referral to specialized CHR case management services.
Receives: Behavioral: Treatment as usual (TAU)
Brief intervention groupExperimentalTAU + experimental intervention. The experimental group will receive all services provided to the TAU group (described above) and, additionally, the experimental intervention.The intervention includes 1 individual session for each teen and parent and 2 family sessions (focused on psychoeducation and motivational enhancement) with both the teen and parent, delivered during hospitalization (~45-60 minutes per session).
Receives: Behavioral: Brief family engagement intervention for CHR

What is being measured

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

  1. mental health literacy

    Measured using the Mental Health Literacy Questionnaire (MHLq): a self-report measure that includes 33 items rated on a 5-point Likert scale (1 = strongly disagree- 5 = strongly agree. Items assess knowledge and awareness of mental health, and factors that contribute to both illness and wellness.

    Measured: Change from baseline MHLq scores at 3-month follow-up

  2. treatment attitudes

    Measured using the Motivation for Youth's Treatment Scale (MYTS): an 8-item measure of motivation to engage in treatment at baseline and at follow-ups. The total scale and two subscales (Problem Recognition and the Treatment Readiness) produce alpha coefficients of above .80

    Measured: Change from baseline MYTS scores at 3-month follow-up

  3. family partnership

    Measured using the Parent Motivation Inventory (PMI): The PMI is a 25-item self-report measure of parent treatment motivation, rated on a five-point scale (1 = strongly disagree - 5 = strongly agree). Items correspond to three components of motivation including: 1) desire for child change, 2) readiness to change parent behavior, and 3) perceived ability to change parent behaviors.

    Measured: Change from baseline PMI scores at 3-month follow-up

Secondary outcomes (2)
  1. outpatient service use

    Service use (i.e. total outpatient appointments attended) will be tracked over the study period.

    Measured: Measured at 3-month follow-up

  2. enrollment in CHR monitoring/case management program

    Rates of enrollment in the CHR monitoring program will be tracked over the study period.

    Measured: Measured at 3-month follow-up

Timeline

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

  1. First posted19 Mar 2020
  2. Study start29 Jun 2020
  3. Primary completion1 Aug 2023 (estimated)
  4. Study completion30 Nov 2023 (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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04314635
Sponsor's protocol ID
1K23MH119211
Status last verified
Oct 2022
First submitted
16 Mar 2020
Last updated
6 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Brief family engagement intervention for CHR and Treatment as usual (TAU) in people with Psychosis Nos/Other, run by Rhode Island Hospital 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 4 inclusion and 4 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 6 Oct 2022. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Elizabeth Thompson, PhD (401-432-1617, elizabeth_thompson@brown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

mental health literacy (time frame: Change from baseline MHLq scores at 3-month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 6 Oct 2022.

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