Clinical High RiskNCT06774430
Digital Strategies to Advance Help-Seeking Aim 1 and 2
An observational study of Clinical High Risk and Early Psychosis, run by Columbia University at 1 site in United States.
Trial summary
This proposal aims to establish a Digital Laboratory focused on advancing help-seeking and expediting treatment initiation in youth ages 12-29 who are at Clinical High-Risk (CHR) for developing psychosis. Read more about this study
- Who is it for?
- Ages 12 to 29 years
- Conditions the study is for
- Clinical High Risk, Early Psychosis, First Episode Psychosis
- How many people
- 25,000 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2025to 31 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 29 years
- All sexes
- Child, Adult
Study population: Based on current MHA user demographic data, the investigators expect a high percentage of youth from low-income families (over 50% report household income below $40,000/year) who have never been in psychiatric care (65% of those who screen positive report having no mental health diagnosis). MHA visitors who complete the PQ-B are a diverse and representative sample of US youth in terms of racial, ethnic, sexual orientation, and gender identity.
Who may be able to join
- Ages 12-29 years
- Living within a 50-mile radius of a US based AMP-SCZ site
- Able to complete the English language PQ-B on MHA's screening platform
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Michael Birnbaum, MD, 212-523-2154, mlb2216@cumc.columbia.edu
About this study
Official title: Digital Strategies to Advance Help-Seeking in Youth at Clinical High Risk for Developing Psychosis
This proposal aims to establish a Digital Laboratory focused on advancing help-seeking and expediting treatment initiation in youth ages 12-29 who are at Clinical High-Risk (CHR) for developing psychosis. Leveraging the Health Action Process Approach (HAPA) model, this study will identify help-seeking subtypes in 25,000 youth who screen positive for psychosis-risk on Mental Health America's national online screening platform, iteratively develop and test theory and data-driven, personalized strategies to advance help-seeking using Micro-Randomized Trials and a Sequential Multiple Assignment Randomized Trial, identify the most accurate CHR screening threshold in an online environment, and link youth, when indicated, to local clinical care via Accelerating Medicines Partnership - Schizophrenia (AMP-SCZ), a NIH funded national network of CHR programs throughout the US. This academic-industry partnership aims to curate one of the largest datasets of youth with CHR, and to develop effective strategies to enhance early help-seeking, in a population where help-seeking is critical and a significant barrier to care.
Read the detailed description
Aim 1: Characterize help-seeking patterns in 25,000 youth who score above Prodromal-Questionnaire (PQ-B) threshold. H1a: Youth will cluster into (1) pre-intenders (take the PQ-B and engage with educational content), (2) intenders (initiate a text exchange with a Strong365 peer navigator (3) actors (advance from texting to clinical assessment with a Strong365 clinician over phone/video) and (4) super-actors (advance from assessment to AMP-SCZ intake). Data will include online metadata (time spent online, # of resources viewed, time spent to complete the PQ-B, # of texts initiated/exchanged), self-report (demographics, symptom type and severity, PQ-B score, goals/needs, self-efficacy), and natural language. H1b (Strong365 only): Natural Language Processing (NLP) of data extracted from participant/provider interactions over text and video will identify linguistic markers of HAPA stages: intender, actor, super-actor. Models based on HAPA stages, along with behavioral features (i.e., message timing, frequency, response lag) will predict help-seeking advancement vs. disengagement. Top predictive features will be used to inform the crafting of help-seeking advancement strategies to be tested in MRTs (Aim 3).
Aim 2: To ensure that those who complete the PQ-B are directed appropriately, this study will establish the most accurate threshold for identifying CHR online. H2: Using data from population-based PQ-B screening, the investigators predict that a total distress score of 20+ will generate the highest diagnostic odds ratio with a sensitivity of at least 80% online, as determined by remote clinical assessment. For the remainder of the study, the threshold score that maximizes specificity and sensitivity will be used.
- Conditions
- Clinical High Risk, Early Psychosis, First Episode Psychosis
- Medical subject headings
- Psychotic Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Aim 1: Proportion of participants in each help-seeking category
Data from participants, including online metadata (time spent online, # of resources viewed, time spent to complete the PQ-B, # of texts initiated/exchanged), self-report (demographics, symptom type and severity, PQ-B score, goals/needs, self-efficacy), and natural language will be used to cluster participants into 4 categories: (1) Pre-intenders (take the PQ-B); (2) Intenders (initiate a text exchange with a peer navigator; (3) Actors (advance to clinical assessment); and (4) Super-actors (advance to intake).
Measured: 1 year
Aim 2: Threshold score for identifying Clinical High-Risk Youth online
This score will be determined using data from population-based PQ-B screening. A total distress score of 20+ is predicted to generate the highest diagnostic odds ratio with a sensitivity of at least 80% online, as determined by remote clinical assessment. For the remainder of the study, a threshold score that maximizes specificity and sensitivity will be used.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start7 Apr 2025
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical High RiskStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Michael Birnbaum, Columbia University
- Investigators
- Michael Birnbaum, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06774430
- Sponsor's protocol ID
- AAAV1315 Aim 1 and 2
- Other IDs
- 1R01MH133569-01A1
- Status last verified
- Apr 2026
- First submitted
- 13 Jan 2025
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Strategies to Advance Help-Seeking in Youth at Clinical High Risk for Developing Psychosis
- ClinicalTrials.gov ID
- NCT06774430
- Acronym / sponsor ID
- AAAV1315 Aim 1 and 2
- Conditions
- Clinical High Risk, Early Psychosis, First Episode Psychosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25,000 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 14 Jan 2025 (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.
This proposal aims to establish a Digital Laboratory focused on advancing help-seeking and expediting treatment initiation in youth ages 12-29 who are at Clinical High-Risk (CHR) for developing psychosis. Leveraging the Health Action Process Approach (HAPA) model, this study will identify help-seeking subtypes in 25,000 youth who screen positive for psychosis-risk on Mental Health America's national online screening platform, iteratively develop and test theory and data-driven, personalized strategies to advance help-seeking using Micro-Randomized Trials and a Sequential Multiple Assignment Randomized Trial, identify the most accurate CHR screening threshold in an online environment, and link youth, when indicated, to local clinical care via Accelerating Medicines Partnership - Schizophrenia (AMP-SCZ), a NIH funded national network of CHR programs throughout the US. This academic-industry partnership aims to curate one of the largest datasets of youth with CHR, and to develop effective strategies to enhance early help-seeking, in a population where help-seeking is critical and a significant barrier to care.
Detailed description
Aim 1: Characterize help-seeking patterns in 25,000 youth who score above Prodromal-Questionnaire (PQ-B) threshold. H1a: Youth will cluster into (1) pre-intenders (take the PQ-B and engage with educational content), (2) intenders (initiate a text exchange with a Strong365 peer navigator (3) actors (advance from texting to clinical assessment with a Strong365 clinician over phone/video) and (4) super-actors (advance from assessment to AMP-SCZ intake). Data will include online metadata (time spent online, # of resources viewed, time spent to complete the PQ-B, # of texts initiated/exchanged), self-report (demographics, symptom type and severity, PQ-B score, goals/needs, self-efficacy), and natural language. H1b (Strong365 only): Natural Language Processing (NLP) of data extracted from participant/provider interactions over text and video will identify linguistic markers of HAPA stages: intender, actor, super-actor. Models based on HAPA stages, along with behavioral features (i.e., message timing, frequency, response lag) will predict help-seeking advancement vs. disengagement. Top predictive features will be used to inform the crafting of help-seeking advancement strategies to be tested in MRTs (Aim 3).
Aim 2: To ensure that those who complete the PQ-B are directed appropriately, this study will establish the most accurate threshold for identifying CHR online. H2: Using data from population-based PQ-B screening, the investigators predict that a total distress score of 20+ will generate the highest diagnostic odds ratio with a sensitivity of at least 80% online, as determined by remote clinical assessment. For the remainder of the study, the threshold score that maximizes specificity and sensitivity will be used.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 29 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Based on current MHA user demographic data, the investigators expect a high percentage of youth from low-income families (over 50% report household income below $40,000/year) who have never been in psychiatric care (65% of those who screen positive report having no mental health diagnosis). MHA visitors who complete the PQ-B are a diverse and representative sample of US youth in terms of racial, ethnic, sexual orientation, and gender identity.
Key inclusion criteria (3 listed)
- Ages 12-29 years
- Living within a 50-mile radius of a US based AMP-SCZ site
- Able to complete the English language PQ-B on MHA's screening platform
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Aim 1: Proportion of participants in each help-seeking category
Time frame: 1 year
Data from participants, including online metadata (time spent online, # of resources viewed, time spent to complete the PQ-B, # of texts initiated/exchanged), self-report (demographics, symptom type and severity, PQ-B score, goals/needs, self-efficacy), and natural language will be used to cluster participants into 4 categories: (1) Pre-intenders (take the PQ-B); (2) Intenders (initiate a text exchange with a peer navigator; (3) Actors (advance to clinical assessment); and (4) Super-actors (advance to intake).
Aim 2: Threshold score for identifying Clinical High-Risk Youth online
Time frame: 1 year
This score will be determined using data from population-based PQ-B screening. A total distress score of 20+ is predicted to generate the highest diagnostic odds ratio with a sensitivity of at least 80% online, as determined by remote clinical assessment. For the remainder of the study, a threshold score that maximizes specificity and sensitivity will be used.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
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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.
Michael Birnbaum, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clinical High Risk and Early Psychosis, run by Columbia University at 1 site in United States.
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 3 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 5 May 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Birnbaum, MD (212-523-2154, mlb2216@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aim 1: Proportion of participants in each help-seeking category (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 May 2026.