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

Primary Purpose

Psychosis Nos/Other

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Brief family engagement intervention for CHR
Treatment as usual (TAU)
Sponsored by
Rhode Island Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychosis Nos/Other focused on measuring clinical high risk (CHR)

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Bradley HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

TAU comparison group

Brief intervention group

Arm Description

TAU 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.

TAU + 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).

Outcomes

Primary Outcome Measures

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.
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
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.

Secondary Outcome Measures

outpatient service use
Service use (i.e. total outpatient appointments attended) will be tracked over the study period.
enrollment in CHR monitoring/case management program
Rates of enrollment in the CHR monitoring program will be tracked over the study period.

Full Information

First Posted
March 16, 2020
Last Updated
October 5, 2022
Sponsor
Rhode Island Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04314635
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 29, 2020 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rhode Island Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis Nos/Other
Keywords
clinical high risk (CHR)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TAU comparison group
Arm Type
Active Comparator
Arm Description
TAU 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.
Arm Title
Brief intervention group
Arm Type
Experimental
Arm Description
TAU + 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).
Intervention Type
Behavioral
Intervention Name(s)
Brief family engagement intervention for CHR
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual (TAU)
Intervention Description
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.
Primary Outcome Measure Information:
Title
mental health literacy
Description
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.
Time Frame
Change from baseline MHLq scores at 3-month follow-up
Title
treatment attitudes
Description
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
Time Frame
Change from baseline MYTS scores at 3-month follow-up
Title
family partnership
Description
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.
Time Frame
Change from baseline PMI scores at 3-month follow-up
Secondary Outcome Measure Information:
Title
outpatient service use
Description
Service use (i.e. total outpatient appointments attended) will be tracked over the study period.
Time Frame
Measured at 3-month follow-up
Title
enrollment in CHR monitoring/case management program
Description
Rates of enrollment in the CHR monitoring program will be tracked over the study period.
Time Frame
Measured at 3-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Thompson, PhD
Phone
401-432-1617
Email
elizabeth_thompson@brown.edu
Facility Information:
Facility Name
Bradley Hospital
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02915
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Thompson, PhD
Email
elizabeth_thompson@brown.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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