Clinical trial NCT04314635: A Treatment Engagement Protocol for Psychiatrically Hospitalized Adolescents at Clinical High Risk for Psychosis
Official title: A Treatment Engagement Protocol to Improve Follow-Up Care for Psychiatrically Hospitalized Adolescents at Clinical High Risk for Psychosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Psychosis Nos/Other
Keywords: clinical high risk (CHR)
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
First posted: 2020-03-19
Enrollment: 80
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: mental health literacy
timeFrame: Change from baseline MHLq scores at 3-month follow-up
measure: treatment attitudes
timeFrame: Change from baseline MYTS scores at 3-month follow-up
measure: family partnership
timeFrame: Change from baseline PMI scores at 3-month follow-up
Secondary outcomes:
measure: outpatient service use
timeFrame: Measured at 3-month follow-up
measure: enrollment in CHR monitoring/case management program
timeFrame: Measured at 3-month follow-up
Other outcomes:
Locations:
city: East Providence
country: United States
facility: Bradley Hospital
state: Rhode Island
Study officials:
References: