Clinical High RiskNCT06774417
Digital Strategies to Advance Help-Seeking - Aim 3
A study testing Digital nudge in people with 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
- What is being tested?
- Digital nudge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25,000 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2026to 31 May 2028
- Phase
- Interventional
- 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
- No healthy volunteers
- Child, Adult
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 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
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. Despite the implementation of evidence-based early intervention services across the U.S., CHR youth wait months to years between symptom onset and receiving care, resulting in significantly worse outcomes. Current CHR identification strategies have relied on costly, inefficient, and outdated resources. Global efforts to expedite treatment initiation in CHR youth, have catalyzed unprecedented demand for innovative digital healthcare solutions aimed at increasing access to available and effective treatment options. Searching online represents one of the first proactive step towards treatment initiation, yet very little research to date has informed how best to support CHR youth as they engage in critical early online help-seeking steps towards care.
To address this knowledge gap, this study involves a partnership between Mental Health America (MHA), the world's largest online mental health screening and advocacy organization, Strong365, an online resource hub dedicated to early psychosis education and care navigation, Accelerating Medicines Partnership - Schizophrenia (AMP-SCZ), a NIH-funded network of CHR programs across the US, and four academic partners with expertise in the assessment and management of CHR youth (Columbia, UCSF, UCD) online psychosis screening and care navigation (Columbia, UCD) and digital mental health engagement (UW, Columbia). Building on MHA's research partnership focused on digital mental health engagement (R01MH125179), this approach leverages the Health Action Process Approach (HAPA) model, which describes how individuals move from intention to action when considering behavioral change. This study will first characterize help-seeking subtypes in 25,000 youth who score above threshold for psychosis-risk on the Prodromal-Questionnaire (PQ-B), on MHA's national screening platform. Next, the investigators will use this large dataset to establish the PQ-B score most effective at identifying CHR youth online, given that the risk of false positives may be higher in online self-screening, and that optimal thresholds can vary depending upon sample prevalence, population, and setting. The investigators will then iteratively develop and test theory and data driven digital strategies using a series of Micro Randomized Trials (MRT) designed to advance help-seeking in CHR youth from pre-intention to intention, from intention to action, and from action to super-action by directly engaging HAPA target mechanisms: self-efficacy, perceived needs/risks, and outcome expectancies. The specific aims and hypotheses include:
Aim 1: Characterize help-seeking patterns in 25,000 youth who score above 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.
Aim 3: Iteratively develop, test, and select the most effective help-seeking advancement strategies using MRTs in 25,000 youth, at 3 timepoints along the pathway to care when youth are most likely to disengage (post PQ-B completion, post texting with a peer navigator, post remote clinical assessment). H3a: Digital strategies on the PQ-B results page will advance youth from online screening alone to texting (pre-intender to intender). Strategies to enhance task self-efficacy and outcome expectancies will be more effective than post-screening information as usual. H3b: Automated digital strategies delivered over text will advance youth from texting to remote clinical assessment (intender to actor). Strategies to enhance task self-efficacy and outcome expectancies will be more effective than control messages. H3c: Automated digital strategies delivered over text will advance youth from assessment to AMP-SCZ intake and treatment initiation, when indicated (actor to super-actor). Strategies to enhance maintenance and recovery self-efficacy will be more effective than control messages.
- Conditions
- Clinical High Risk, Early Psychosis, First Episode Psychosis
- Being tested
- Digital nudge
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital nudgeOther
Digital help seeking advancement strategies over text and online.
| Study group | Role | What they receive |
|---|---|---|
| Self-Efficacy Nudge | Active comparator | Participants will be randomized with equal probability into a unique HAPA construct category at baseline and this randomization process will continue as participants advance towards care Receives: Other: Digital nudge |
| Needs/Risks Nudge | Active comparator | Participants will be randomized with equal probability into a unique HAPA construct category at baseline and this randomization process will continue as participants advance towards care Receives: Other: Digital nudge |
| Outcome expectations | Active comparator | Participants will be randomized with equal probability into a unique HAPA construct category at baseline and this randomization process will continue as participants advance towards care Receives: Other: Digital nudge |
| Neutral nudge | No intervention | Participants will be randomized with equal probability into a unique HAPA construct category at baseline and this randomization process will continue as participants advance towards care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of youth who initiate a text or schedule an assessment after scoring PQ-B (Prodromal-Questionnaire) positive
Initiating a text or scheduling an assessment after scoring PQ-B positive
Measured: 2 weeks
Proportion of youth who advance to complete a clinical assessment
Advancing to complete a remote clinical assessment.
Measured: 2 weeks
Proportion of youth who advance to care
Advancing to local AMP-SCZ (Accelerating Medicines Partnership - Schizophrenia) intake and treatment initiation, if indicated.
Measured: 2 weeks
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 start2 Feb 2026
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Micro randomized trials (MRTs) are designed to repeatedly randomize participants several times over the course of a trial, facilitating effectiveness testing of multiple components of digital interventions including their timing (when the intervention is delivered), frequency (number of times an intervention is delivered) and content (the substance of the intervention, such as the specific wording in a text reminder). Using a stepped approach to MRTs, participants will be randomized with equal probability into a unique HAPA construct category at baseline and this randomization process will continue as participants advance towards care
- Masking
- None (open label)
- Enrolment
- 25,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, University of California, Davis, Mental Health America, University of Washington, Strong365, 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
- NCT06774417
- Sponsor's protocol ID
- AAAV1315 - Aim 3
- Other IDs
- 1R01MH133569-01A1
- Status last verified
- Jun 2026
- First submitted
- 13 Jan 2025
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 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
- NCT06774417
- Acronym / sponsor ID
- AAAV1315 - Aim 3
- Conditions
- Clinical High Risk, Early Psychosis, First Episode Psychosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25,000 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- University of California, San Francisco, University of California, Davis, Mental Health America, University of Washington, Strong365, National Institute of Mental Health (NIMH)
- Study start
- 2 Feb 2026 (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 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
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. Despite the implementation of evidence-based early intervention services across the U.S., CHR youth wait months to years between symptom onset and receiving care, resulting in significantly worse outcomes. Current CHR identification strategies have relied on costly, inefficient, and outdated resources. Global efforts to expedite treatment initiation in CHR youth, have catalyzed unprecedented demand for innovative digital healthcare solutions aimed at increasing access to available and effective treatment options. Searching online represents one of the first proactive step towards treatment initiation, yet very little research to date has informed how best to support CHR youth as they engage in critical early online help-seeking steps towards care.
To address this knowledge gap, this study involves a partnership between Mental Health America (MHA), the world's largest online mental health screening and advocacy organization, Strong365, an online resource hub dedicated to early psychosis education and care navigation, Accelerating Medicines Partnership - Schizophrenia (AMP-SCZ), a NIH-funded network of CHR programs across the US, and four academic partners with expertise in the assessment and management of CHR youth (Columbia, UCSF, UCD) online psychosis screening and care navigation (Columbia, UCD) and digital mental health engagement (UW, Columbia). Building on MHA's research partnership focused on digital mental health engagement (R01MH125179), this approach leverages the Health Action Process Approach (HAPA) model, which describes how individuals move from intention to action when considering behavioral change. This study will first characterize help-seeking subtypes in 25,000 youth who score above threshold for psychosis-risk on the Prodromal-Questionnaire (PQ-B), on MHA's national screening platform. Next, the investigators will use this large dataset to establish the PQ-B score most effective at identifying CHR youth online, given that the risk of false positives may be higher in online self-screening, and that optimal thresholds can vary depending upon sample prevalence, population, and setting. The investigators will then iteratively develop and test theory and data driven digital strategies using a series of Micro Randomized Trials (MRT) designed to advance help-seeking in CHR youth from pre-intention to intention, from intention to action, and from action to super-action by directly engaging HAPA target mechanisms: self-efficacy, perceived needs/risks, and outcome expectancies. The specific aims and hypotheses include:
Aim 1: Characterize help-seeking patterns in 25,000 youth who score above 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.
Aim 3: Iteratively develop, test, and select the most effective help-seeking advancement strategies using MRTs in 25,000 youth, at 3 timepoints along the pathway to care when youth are most likely to disengage (post PQ-B completion, post texting with a peer navigator, post remote clinical assessment). H3a: Digital strategies on the PQ-B results page will advance youth from online screening alone to texting (pre-intender to intender). Strategies to enhance task self-efficacy and outcome expectancies will be more effective than post-screening information as usual. H3b: Automated digital strategies delivered over text will advance youth from texting to remote clinical assessment (intender to actor). Strategies to enhance task self-efficacy and outcome expectancies will be more effective than control messages. H3c: Automated digital strategies delivered over text will advance youth from assessment to AMP-SCZ intake and treatment initiation, when indicated (actor to super-actor). Strategies to enhance maintenance and recovery self-efficacy will be more effective than control messages.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Micro randomized trials (MRTs) are designed to repeatedly randomize participants several times over the course of a trial, facilitating effectiveness testing of multiple components of digital interventions including their timing (when the intervention is delivered), frequency (number of times an intervention is delivered) and content (the substance of the intervention, such as the specific wording in a text reminder). Using a stepped approach to MRTs, participants will be randomized with equal probability into a unique HAPA construct category at baseline and this randomization process will continue as participants advance towards care
| Arm | Type | Receives |
|---|---|---|
| Self-Efficacy Nudge | Active comparator | Other: Digital nudgeParticipants will be randomized with equal probability into a unique HAPA construct category at baseline and this randomization process will continue as participants advance towards care |
| Needs/Risks Nudge | Active comparator | Other: Digital nudgeParticipants will be randomized with equal probability into a unique HAPA construct category at baseline and this randomization process will continue as participants advance towards care |
| Outcome expectations | Active comparator | Other: Digital nudgeParticipants will be randomized with equal probability into a unique HAPA construct category at baseline and this randomization process will continue as participants advance towards care |
| Neutral nudge | No intervention | –Participants will be randomized with equal probability into a unique HAPA construct category at baseline and this randomization process will continue as participants advance towards care |
Who may qualify
- Ages
- 12 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital nudgeDigital help seeking advancement strategies over text and online. | Other | Needs/Risks Nudge, Outcome expectations, Self-Efficacy Nudge |
Primary outcome
Proportion of youth who initiate a text or schedule an assessment after scoring PQ-B (Prodromal-Questionnaire) positive
Time frame: 2 weeks
Initiating a text or scheduling an assessment after scoring PQ-B positive
Proportion of youth who advance to complete a clinical assessment
Time frame: 2 weeks
Advancing to complete a remote clinical assessment.
Proportion of youth who advance to care
Time frame: 2 weeks
Advancing to local AMP-SCZ (Accelerating Medicines Partnership - Schizophrenia) intake and treatment initiation, if indicated.
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 18 Jun 2026.
- 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.
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?
A study testing Digital nudge in people with 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 18 Jun 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?
Proportion of youth who initiate a text or schedule an assessment after scoring PQ-B (Prodromal-Questionnaire) positive (time frame: 2 weeks). The study lists 3 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 18 Jun 2026.