Digital Strategies to Advance Help-Seeking - Aim 3

NCT06774417 | Recruiting

• 2 other identifiers: AAAV1315 - Aim 31R01MH133569-01A1
• Study Type: interventional
• Target: 25,000
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Early Psychosis; First Episode Psychosis; Clinical High Risk

Outcome Measures

Primary Outcomes (3)

• 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

  2 weeks

• Proportion of youth who advance to complete a clinical assessment

  Advancing to complete a remote clinical assessment.

  2 weeks

• Proportion of youth who advance to care

  Advancing to local AMP-SCZ (Accelerating Medicines Partnership - Schizophrenia) intake and treatment initiation, if indicated.

  2 weeks

Study Arms (4)

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

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

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

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

Interventions

Digital nudge OTHER

Digital help seeking advancement strategies over text and online.

Needs/Risks Nudge; Outcome expectations; Self-Efficacy Nudge

Eligibility Criteria

• Age: 12 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• Mental Health America: collaborator
• University of California, San Francisco: collaborator
• University of California, Davis: collaborator
• University of Washington: collaborator
• Strong365: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Michael Birnbaum, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Birnbaum, MD

CONTACT

212-523-2154; mlb2216@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst Professor of Clinical

Model Details: 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

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 14, 2025
• Study Start: February 2, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: March 23, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)