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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 is a NA study that has completed, run by Seattle Children's Hospital. The registered enrollment target is 51 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05135065
The ClinicalTrials.gov registry entry for NCT05135065 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seattle Children's Hospital, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Artificial Intelligence-Assisted Supervision Protocol is the first listed.
NCT05135065 reports 0 study locations.
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.
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