| NCT ID | NCT06915480 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Hugo W. Moser Research Institute at Kennedy Krieger, Inc. |
| Condition | Neurodevelopmental Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 5,000 participants |
| Start Date | 2025-12-29 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 5,000 participants in total. It began in 2025-12-29 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
There are four goals of this project: (1) To examine the impact of different appointment reminder messages on appointment attendance; (2) to determine the added benefit of a patient navigator reaching out in advance of appointments to families at elevated risk of missing their appointment, and determine the most common barriers families face in appointment attendance; (3) to evaluate which patients are at highest risk of missing their appointment, and to determine the effectiveness of the intervention trial across different patient risk levels; and (4) to examine if the missing appointment interventions increase the socioeconomic diversity patients.
Eligibility Criteria
Inclusion Criteria: * All patients who are scheduled to be seen within the center for autism or the center for neuropsychological and psychological assessment for evaluation appointments will be automatically enrolled in the reminder message portion of the intervention trial. * Patients who are at elevated risk within the center for neuropsychological and psychological assessment are automatically enrolled in the patient navigator portion of the intervention trial. Exclusion criteria: * None for the messaging portion of the study * For patient navigation, patients \>18 years of age will be excluded.
Contact & Investigator
luther G kalb, PhD
PRINCIPAL INVESTIGATOR
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Frequently Asked Questions
Who can join the NCT06915480 clinical trial?
This trial is open to participants of all sexes, aged 1 Month or older, up to 24 Years, studying Neurodevelopmental Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06915480 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 5,000 participants.
Is NCT06915480 currently recruiting?
Yes, NCT06915480 is actively recruiting participants. Contact the research team at kalb@kennedykrieger.org for enrollment information.
Where is the NCT06915480 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT06915480 clinical trial?
NCT06915480 is sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.. The principal investigator is luther G kalb, PhD at Hugo W. Moser Research Institute at Kennedy Krieger, Inc.. The trial plans to enroll 5,000 participants.