Digital Strategies to Advance Help-Seeking Aim 1 and 2 (NCT06774430) | Clinical Trial Compass
RecruitingNot Applicable
Digital Strategies to Advance Help-Seeking Aim 1 and 2
United States25,000 participantsStarted 2025-04-07
Plain-language 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 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.
Who can participate
Age range
12 Years – 29 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial seems focused on studying how young people seek help online for early psychosis rather than testing a new treatment — does that mean there's no direct therapeutic benefit for my child, and is this the right step before exploring actual treatment programs?
2Since this is a non-interventional study categorized as Phase NA, what exactly would my child be asked to do as a participant, and are there any emotional or psychological risks from answering questions about psychosis symptoms?
3The trial is trying to identify a 'threshold score' to spot Clinical High-Risk youth through online tools — if my child participates and meets that threshold, would they automatically be connected to clinical care, or is this purely research data?
4Given that my child may already be at Clinical High Risk or experiencing a first episode of psychosis, should we be prioritizing getting them into an established Early Psychosis Intervention program right now rather than a help-seeking research study?
5Could participating in this study delay or interfere with my child starting any treatment, or is it something they could do alongside receiving care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Aim 1: Proportion of participants in each help-seeking category
Timeframe: 1 year
2
Aim 2: Threshold score for identifying Clinical High-Risk Youth online