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NCT05135065 · ClinicalTrials.gov registry record · NA
Community-Based Care for Minority Adolescents With ADHD: Improving Fidelity With Machine Learning-Assisted Supervision and Fidelity Feedback.
A NA study, sponsored by Seattle Children's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 51
- Enrollment target
NCT05135065: Completed NA study, sponsored by Seattle Children's Hospital.
NCT05135065 is a NA study that has completed, run by Seattle Children's Hospital. The registered enrollment target is 51 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05135065, a NA study, has completed, sponsored by Seattle Children's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 51 participants
- Enrollment target
Study Summary
This project proposes to reduce disparities in care among disadvantaged racial/ethnic minority adolescents with ADHD by improving community therapist fidelity to evidence-based behavior therapy through a technology-assisted supervision intervention. In Y01, the research team will work with stakeholders to develop the proposed supervision intervention utilizing two novel technologies: Lyssn + Care4 (LC4S). In Y02, a preliminary clinical trial (N=72) will be conducted in three community mental health agencies in Miami, FL. Adolescent participants will be randomly assigned to receive supervision from a therapist who is trained in LCS4 or provides enhanced supervision as usual(ESAU)using a permuted block randomization strategy that randomizes within site. There will also be double randomization of agency therapists to supervisors. Supervisors will deliver both conditions and investigators will test for contamination to determine the integrity of this design prior to a future R01 that measures patient outcomes. Data from therapists, adolescents and their parents, and supervisors will be collected pre-training, post-training, weekly during service delivery, at EBT completion, and at the end of the trial. The proximal intervention target is therapist fidelity to EBT and the distal targets are service delivery outcomes that include quality, quantity, and speed of delivery. Investigators will also measure indices of consumer fit: cost, acceptability, feasibility, and fidelity to supervision procedures. Sources of data will be audio recorded therapy and supervision sessions, therapist and supervisor report, and project and electronic health records. In longitudinal analyses, time will be modeled as a person-specific variable representing months since baseline. Investigators will nest adolescents within therapists for all analyses.
Primary Outcome
Behavior therapy content: STAND treatment fidelity checklists (Sibley et al., 2013, 2016, 2019). This data will be collected via therapist self-report, Lyssn (the machine learning tool), and coded by trained research assistants from audio recordings. If there is a discrepancy in sources, a trained RA will code the tape to resolve the discrepancy.
Interventions
- OTHER Artificial Intelligence-Assisted Supervision Protocol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2021-11-18 |
| Est. Completion | 2024-12-01 |
| Phase | NA |
What the finished NCT05135065 record still lists
NCT05135065 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Artificial Intelligence-Assisted Supervision Protocol is the first listed.
NCT05135065 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05135065 about?
NCT05135065 is a clinical study titled "Community-Based Care for Minority Adolescents With ADHD: Improving Fidelity With Machine Learning-Assisted Supervision and Fidelity Feedback.". This project proposes to reduce disparities in care among disadvantaged racial/ethnic minority adolescents with ADHD by improving community therapist fidelity to evidence-based behavior therapy through a technology-assisted supervision intervention. In Y01, the research team will work with stakehold...
What is the current status of trial NCT05135065?
This trial is currently completed. It is a NA study. The enrollment target is 51 participants. The study started on 2021-11-18. Estimated completion is 2024-12-01.
What interventions are being tested in trial NCT05135065?
The interventions under investigation include: Artificial Intelligence-Assisted Supervision Protocol (OTHER).
Who is sponsoring clinical trial NCT05135065?
This trial is sponsored by Seattle Children's Hospital, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05135065's enrollment target sits among peer trials
51 1279th of 2000 higher than 722 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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