About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

8+ years old

Attends Roodhouse Elementary or North Greene Jr. High School

Screening SDQ-P Total Difficulties Score ≥17 and Total Impact Score ≥2

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

Melillo Method
Procedure/Surgery
The intervention is delivered by a Melillo Method-certified clinician and a trained assistant in dyadic (n=2) small-group format, three sessions weekly. This group size is intended to preserve a high clinician-to-student ratio for individualized manual therapy while allowing structured peer-to-peer engagement during cooperative timing tasks. Each intervention block begins and concludes with a standardized neurodevelopmental assessment (primitive reflex grading, postural and oculomotor evaluation, Interactive Metronome baseline timing metrics) to characterize functional status independent of the ongoing outcome battery. Participants are assigned to a right- or left-hemisphere-targeted stimulation protocol based on clinical synthesis of neurobehavioral history and observed asymmetry patterns, determining the laterality of sensory stimulation (visual, tactile-vibratory, olfactory, and auditory) and the directionality of oculomotor an

Treatment groups

34 Participants

are divided into 2 treatment groups

Group A: Immediate-startExperimental treatment 1 intervention

Group B: Delayed-startActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of consenting parents

Number of parents who consent, divided by the total number of eligible students identified via the online screen. This assesses 'Consent rate'

Time frame