Community-Based Care for Minority Adolescents With ADHD: Improving Fidelity With Machine Learning-Assisted Supervision and Fidelity Feedback.
Public ClinicalTrials.gov record NCT05135065. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05135065
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 51 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 11 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 17, 2021
- Primary completion
- Aug 29, 2024
- Completion
- Nov 30, 2024
- Last update posted
- Apr 23, 2026
2021 – 2024
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Seattle Children's Research Institute | Seattle | Washington | 98145 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05135065, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 23, 2026 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05135065 live on ClinicalTrials.gov.