Clinical High Risk for Developing PsychosisNCT04829292
Stepped Care for Youth at Risk of Psychosis
A study testing Supportive therapy and CBT in people with Clinical High Risk for Developing Psychosis, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 30 years
- Conditions the study is for
- Clinical High Risk for Developing Psychosis
- What is being tested?
- Supportive therapy and CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2021to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Meeting SIPS criteria for clinical high risk for psychosis
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Mathison Centre for Research and Education, University of Calgary
Calgary, Alberta, T2N 4Z6
About this study
Official title: A Framework for Research in Emerging Adults: Stepped Care for Youth at Risk of Psychosis
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
Read the 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 12 and 30. 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.
- Being tested
- Supportive therapy and CBT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive therapy and CBTBehavioural
In this open trial participants are first offered supportive therapy followed by CBT
| Study group | Role | What they receive |
|---|---|---|
| Open treatment | Experimental | Supportive therapy followed by CBT Receives: Behavioral: Supportive therapy and CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scale of Psychosis Risk Symptoms
Individuals' clinical symptoms will be measured using scores on positive symptoms on the SOPS.
Measured: Baseline and 18 months
Secondary outcomes (1)
Global Functioning Scale: Social and Role
Clinical rating scales to assess if there are changes in social and role functioning.
Measured: Baseline and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start1 Sep 2021
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clinical High Risk for Developing PsychosisStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean Addington, PhD, University of Calgary
- Investigators
- Jean M Addington, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04829292
- Sponsor's protocol ID
- ACH Foundation
- Status last verified
- Sep 2026
- First submitted
- 29 Mar 2021
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Addington J, Liu L, Jahraus C, Jones E, Singh J. Psychoeducation for Youth at Clinical High-Risk of Psychosis. Early Interv Psychiatry. 2026 Oct;20(10):e70274. doi: 10.1111/eip.70274.
PubMed 42827309
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Framework for Research in Emerging Adults: Stepped Care for Youth at Risk of Psychosis
- ClinicalTrials.gov ID
- NCT04829292
- Acronym / sponsor ID
- ACH Foundation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 2 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 12 and 30. 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open treatment | Experimental | Behavioral: Supportive therapy and CBTSupportive therapy followed by CBT |
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Meeting SIPS criteria for clinical high risk for psychosis
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supportive therapy and CBTIn this open trial participants are first offered supportive therapy followed by CBT | Behavioural | Open treatment |
Primary outcome
Scale of Psychosis Risk Symptoms
Time frame: Baseline and 18 months
Individuals' clinical symptoms will be measured using scores on positive symptoms on the SOPS.
1 secondary outcome
Global Functioning Scale: Social and Role
Time frame: Baseline and 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Derived from this study: PubMed 42827309Addington J, Liu L, Jahraus C, Jones E, Singh J. Psychoeducation for Youth at Clinical High-Risk of Psychosis. Early Interv Psychiatry. 2026 Oct;20(10):e70274. doi: 10.1111/eip.70274.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean M Addington, PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive therapy and CBT in people with Clinical High Risk for Developing Psychosis, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scale of Psychosis Risk Symptoms (time frame: Baseline and 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04829292, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.