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

NCT04314635 | Unknown Phase 1 DMC

• 1 other identifier: 1K23MH119211
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychosis Nos/Other

Keywords

clinical high risk (CHR)

Outcome Measures

Primary Outcomes (3)

• 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.

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

• 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

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

• 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.

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

Secondary Outcomes (2)

• outpatient service use

  Measured at 3-month follow-up

• enrollment in CHR monitoring/case management program

  Measured at 3-month follow-up

Study Arms (2)

TAU comparison group

ACTIVE COMPARATOR

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.

Behavioral: Treatment as usual (TAU)

Brief intervention group

EXPERIMENTAL

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).

Behavioral: Brief family engagement intervention for CHR

Interventions

Brief family engagement intervention for CHR BEHAVIORAL

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.

Brief intervention group

Treatment as usual (TAU) BEHAVIORAL

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.

TAU comparison group

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rhode Island Hospital: lead

Study Sites (1)

Bradley Hospital

East Providence, Rhode Island, 02915, United States

RECRUITING

MeSH Terms

Interventions

Peroxisomal Biogenesis Factor 2; Therapeutics

Intervention Hierarchy (Ancestors)

Peroxins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Membrane Proteins

Central Study Contacts

Elizabeth Thompson, PhD

CONTACT

401-432-1617; elizabeth_thompson@brown.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Scientist

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: March 19, 2020
• Study Start: June 29, 2020
• Primary Completion: August 1, 2023
• Study Completion: November 30, 2023
• Last Updated: October 6, 2022

Record last verified: 2022-10

Locations

US (1)