Digital Strategies to Advance Help-Seeking Aim 1 and 2

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.

Study Overview

• Status: Recruiting
• Conditions: Clinical High Risk; First Episode Psychosis; Early Psychosis

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 Type: Observational
• Enrollment (Estimated): 25000

Contacts and Locations

• Study Contact: Name: Michael Birnbaum, MD; Phone Number: 212-523-2154; Email: mlb2216@cumc.columbia.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Irving Medical Center
      • Contact: Michael Birnbaum, MD; Phone Number: 212-523-2154; Email: mlb2216@cumc.columbia.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	1 year

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Michael Birnbaum, MD, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2025
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028

Study Registration Dates

• First Submitted: January 13, 2025
• First Submitted That Met QC Criteria: January 13, 2025
• First Posted (Actual): January 14, 2025

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Psychotic Disorders
• Other Study ID Numbers: AAAV1315 Aim 1 and 2; 1R01MH133569-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No