Recruiting
Phase 1

Engagement Protocol

Sponsor:

Rhode Island Hospital

Code:

NCT04314635

Conditions

Psychosis Nos/Other

Eligibility Criteria

Sex: All

Age: 13 - 18

Healthy Volunteers: Not accepted

Interventions

Brief family engagement intervention for CHR

Treatment as usual (TAU)

Study Details

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

Study ID

NCT04314635

Start date

Jun 29, 2020

Status verified date

Oct, 2022

Completion date

Nov 30, 2023

Anticipated

Primary completion date

Aug 1, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 18

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: TAU comparison group

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.

experimental: Brief intervention group

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).

Interventions

Brief family engagement intervention for CHR

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)

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

  • mental health literacy [ Time Frame: Change from baseline MHLq scores at 3-month follow-up ]
  • treatment attitudes [ Time Frame: Change from baseline MYTS scores at 3-month follow-up ]
  • family partnership [ Time Frame: Change from baseline PMI scores at 3-month follow-up ]

Central Contacts and Locations

Central contacts

Elizabeth Thompson, PhD

401-432-1617elizabeth_thompson@brown.edu

Locations

Bradley Hospital

Recruiting

East Providence, Rhode Island, United States, 02915

Contacts

Elizabeth Thompson, PhD

elizabeth_thompson@brown.edu

More Information

Sponsor

Rhode Island Hospital

Last update posted

Oct 6, 2022

Last verified

Oct, 2022

Keywords

  • clinical high risk (CHR)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rhode Island Hospital on 2022-10-06.