34 Participants NeededMy employer runs this trial

Melillo Method for Neurodevelopmental Disorders

(ILL Trial)

Recruiting at 1 trial location
AV
Overseen ByAssociate Vice President of Research
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Life University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This pilot study will test whether a school-based neurodevelopmental brain-training program, called the Melillo Method®, is feasible to deliver and study in elementary and middle school students who are struggling with behavior and learning. The study will enroll about 34 children ages 8 and older at two schools in Illinois. Children will be identified by teachers and school staff as needing extra support, and families will complete a brief questionnaire to confirm eligibility.

Children who qualify will be randomly assigned to start the program right away (24 weeks of sessions) or after a delay (12 weeks of sessions, starting partway through the study). This "delayed-start" design lets every enrolled child eventually receive the program while still allowing researchers to compare outcomes between children who started earlier versus later.

The program combines sensory stimulation (lights, gentle vibration, scent), rhythm-based exercises, primitive reflex integration activities, and balance/coordination training, delivered by a trained clinician in small groups of two. Sessions occur three times per week for about 20 minutes each.

Researchers will measure whether the study procedures are practical and acceptable. For example, how many eligible families enroll, how well families and teachers complete follow-up questionnaires, how well students tolerate the assessments, and how consistently families attend sessions. As a secondary goal, the study will explore whether children show changes in thinking skills, fine motor coordination, and emotional/behavioral functioning, measured using standardized tools (the NIH Toolbox and the Strengths and Difficulties Questionnaire) completed by the children, their parents, and their teachers.

This is a feasibility study. It is not intended to prove that the program works, but rather to determine whether a larger, more rigorous trial is realistic and well-designed.

Who Is on the Research Team?

TP

Tyson Perez

Principal Investigator

Life University

Are You a Good Fit for This Trial?

This trial is for children aged 8 and older in elementary or middle school who are having difficulties with behavior or learning, as identified by teachers or staff. Families must complete a short questionnaire to confirm eligibility.

Inclusion Criteria

Attends Roodhouse Elementary or North Greene Jr. High School
Screening SDQ-P Total Difficulties Score ≥17 and Total Impact Score ≥2
I am at least 8 years old.

Exclusion Criteria

I do not have impairments that prevent me from completing tests or therapy.
I have a history of epilepsy.
I have been diagnosed with ODD or Conduct Disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Immediate-start Treatment

Participants receive Melillo Method therapy for approximately 24 weeks, 3 times per week

24 weeks
72 sessions (in-person)

Delayed-start Treatment

Participants on the waitlist receive Melillo Method therapy for approximately 12 weeks, 3 times per week

12 weeks
36 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Melillo Method®

Trial Overview

The study tests the Melillo Method®, a brain-training program using sensory activities, rhythm exercises, reflex integration, and balance training. Children are randomly assigned to start right away or after a delay; all receive the program in small groups at school.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Immediate-startExperimental Treatment1 Intervention
Group II: Delayed-startActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Life University

Lead Sponsor

Trials
21
Recruited
450+