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Stepped Care for Youth at Risk of Psychosis

Primary Purpose

Clinical High Risk for Developing Psychosis

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Supportive therapy and CBT
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Clinical High Risk for Developing Psychosis

Eligibility Criteria

13 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Meeting SIPS criteria for clinical high risk for psychosis

Exclusion Criteria:

  • meeting criteria for any current or past axis I psychotic disorder, IQ less than 70, or past or current history of a clinically significant central nervous system disorder.

Sites / Locations

  • Mathison Centre for Research and Education, University of CalgaryRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open treatment

Arm Description

Supportive therapy followed by CBT

Outcomes

Primary Outcome Measures

Scale of Psychosis Risk Symptoms
Individuals' clinical symptoms will be measured using scores on positive symptoms on the SOPS.

Secondary Outcome Measures

Global Functioning Scale: Social and Role
Clinical rating scales to assess if there are changes in social and role functioning.

Full Information

First Posted
March 29, 2021
Last Updated
June 14, 2023
Sponsor
University of Calgary
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1. Study Identification

Unique Protocol Identification Number
NCT04829292
Brief Title
Stepped Care for Youth at Risk of Psychosis
Official Title
A Framework for Research in Emerging Adults: Stepped Care for Youth at Risk of Psychosis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
April 30, 2026 (Anticipated)
Study Completion Date
April 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary

4. Oversight

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

5. Study Description

Brief Summary
The study will recruit 60 young people who meet established criteria for being at clinical high risk for psychosis. They will be offered a range of psychological interventions starting with the most benign treatments in different steps. At step 1 they will be offered individual or group support and if there is no improvement they will be offered more intensive CBT individual therapy or CBSST group therapy. Assessments will occur at baseline, 6,12 and 18 months
Detailed Description
In treating youth at clinical high risk of developing psychosis we have not been able to address what treatment to offer first and when to offer more intense and, ultimately, more costly treatments. The goals of achieving Precision Health objectives require that these questions be addressed through research. The overall aim is to determine the most effective and efficient way to offer active and maintenance treatment resources for CHR youth. The first step would be to offer a range of treatments starting with the most benign as advocated in the McGorry and Hickie stage model. We will use this project to test whether clinical staging will improve prediction of prognosis and result in improved matching of treatment. The specific objectives of this project are: (1) to determine which and what proportion of participants would remit (i) within the first 1-2 months of treatment, (ii) after a brief supportive therapy, (iii) after longer term, focused psychological interventions such as CBT, CBSST and family intervention and (iv) how many make use of medications; (2) to determine adherence of CHR individuals to different treatments; and (3) to determine the need for maintenance treatment. To assess these objectives the following outcomes will be determined: Improvement of Attenuated Psychotic Symptoms Improved social functioning as rated by Global: Social Functioning Percentage of the sample that demonstrate either symptomatic or functional improvement after Step 1 treatments and do not require to move to Step 2 treatments. Percentage of sample that move to Step 2 Treatments and the percentage that achieve improvement in either symptoms or functioning. Percentage of participants allocated to a given treatment that adhere to the treatment. Participants will be between ages 13 and 25. We will recruit 60 participants who meet well-established criteria for clinical high risk for psychosis based on the Structured Interview for Psychosis-Risk Syndromes (SIPS). Assessments will be conducted at baseline and 2, 6, 12, and 18 months after baseline. Assessments consist of clinical assessments. Clinical raters will be experienced raters and will be trained on all clinical measures and routine reliability checks will be conducted.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clinical High Risk for Developing Psychosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Open treatment
Arm Type
Experimental
Arm Description
Supportive therapy followed by CBT
Intervention Type
Behavioral
Intervention Name(s)
Supportive therapy and CBT
Intervention Description
In this open trial participants are first offered supportive therapy followed by CBT
Primary Outcome Measure Information:
Title
Scale of Psychosis Risk Symptoms
Description
Individuals' clinical symptoms will be measured using scores on positive symptoms on the SOPS.
Time Frame
Baseline and 18 months
Secondary Outcome Measure Information:
Title
Global Functioning Scale: Social and Role
Description
Clinical rating scales to assess if there are changes in social and role functioning.
Time Frame
Baseline and 18 months

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meeting SIPS criteria for clinical high risk for psychosis Exclusion Criteria: meeting criteria for any current or past axis I psychotic disorder, IQ less than 70, or past or current history of a clinically significant central nervous system disorder.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Monica Chu
Phone
403-210-8737
Email
mochu@ucalgary.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Cari Jahraus
Phone
403-210-8740
Email
cari.jahraus@ucalgary.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean M Addington, PhD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mathison Centre for Research and Education, University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean M Addington, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Stepped Care for Youth at Risk of Psychosis

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