Recruiting
Phase 3

Observational Study

Sponsor:

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Code:

NCT06915480

Conditions

Neurodevelopmental Disorders

Eligibility Criteria

Sex: All

Age: 0 - 24

Healthy Volunteers: Not accepted

Interventions

Reminder message and patient navigation

Study Details

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.

Conditions

Neurodevelopmental Disorders

Study ID

NCT06915480

Start date

Dec 29, 2025

Status verified date

Mar, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 24

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

5000 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: Standard message, no navigator

This arm represents the standard operating procedures. It includes basic appointment information and no personal assistance with appointment navigation.

experimental: Standard message with navigator

This arm represents the standard pre-appointment reminder message. This arm will include personal assistance with appointment navigation.

experimental: Enhanced message #1, no navigator

This arm represents a novel pre-appointment reminder message based on existing scientific literature. This arm will not include personal assistance with appointment navigation.

experimental: Enhanced message #1 with navigator

This arm represents a novel pre-appointment reminder message based on existing scientific literature. This arm will include personal assistance with appointment navigation.

experimental: Enhanced message #2, no navigator

This arm represents a second novel pre-appointment reminder message based on existing scientific literature. This arm will not include personal assistance with appointment navigation.

experimental: Enhanced message #2 with navigator

This arm represents a second novel pre-appointment reminder message based on existing scientific literature. This arm will include personal assistance with appointment navigation.

Interventions

Reminder message and patient navigation

This study will evaluate the combination of pre-appointment messages and patient navigation services.

Primary outcome measure

  • Patient appointment no-show [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

luther G kalb, PhD

4439239439kalb@kennedykrieger.org

Locations

Kennedy Krieger Institute

Recruiting

Baltimore, Maryland, United States, 21211

Contacts

Luke Kalb

443-923-9439

Principal Investigator:

Luther Kalb, PhD

More Information

Sponsor

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Last update posted

Mar 18, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. on 2026-03-18.