Digital Strategies to Advance Help-Seeking Aim 1 and 2
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12-29
SponsorColumbia University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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).
Time frame
1 year2
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.
Time frame
1 yearSponsors and contacts
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Columbia University
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov