Clinical trial Recruiting at 1 site Interventional Ages 8 and up

Melillo Method for kids with behavior and learning challenges

Official title: The Effects of the Melillo Method® on Biopsychosocial Outcomes in School-Age Children: A Pilot Randomized Delayed-Start Trial

Run by Life University · NCT07779889 · Data updated 2026-11-12

This pilot test will see if the Melillo Method can be feasibly delivered in two Illinois schools to help kids aged 8 and up who have behavioral and learning difficulties.

Quick facts

Study typeInterventional
Ages8 Years and up
SexAll
Enrollment34 (estimated)
SponsorLife University
Academic / other
Locations1 site (Roodhouse, Illinois)
StatusRecruiting
StartedSeptember 14, 2026
Main results expectedMay 2027
Study endsMay 2027
Registry record updatedSeptember 22, 2026
Trial IDNCT07779889 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Children aged 8 years or older who attend Roodhouse Elementary or North Greene Jr. High School and have SDQ-P Total Difficulties ≥17 and Total Impact ≥2.

Probably not a fit

Children with epilepsy, or a diagnosis of oppositional defiance or conduct disorder, or who have impairments preventing standard assessments or therapy, may not benefit from this approach.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot randomized study examines a school-based brain-training program called the Melillo Method in elementary and middle school students with social and neurodevelopmental challenges. About 34 participants will be enrolled and randomly assigned to start the program immediately or after a 12-week delay, allowing both groups to receive the intervention while enabling comparison of early versus later start outcomes. The program combines sensory stimulation, rhythm-based activities, reflex integration, and other components designed to improve attention, behavior, and learning. The trial uses a delayed-start design to account for maturation and natural changes over time in a real-world school setting. Outcomes will be measured using teacher and family reports and standardized assessments.

Why it matters

Potential benefit: If successful, the Melillo Method could offer a structured school-based approach to improving behavior and learning in children with neurodevelopmental and social behavior challenges.

How similar studies have gone: This specific randomized, school-based application of the Melillo Method is novel; prior evidence is limited to clinical observations and non-randomized settings.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

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

Exclusion Criteria:

* History of Epilepsy
* Diagnosis of Oppositional Defiance Disorder (ODD) or Conduct Disorder (CD)
* Impairments that preclude standardized administration of the assessments and/or therapy (e.g., uncorrected visual or hearing loss, paralysis of the arms or legs)

Where it's running

  • North Greene School District
    Roodhouse, Illinois, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.