The Effects of the Melillo Method® on Biopsychosocial Outcomes in School-Age Children

Part of paid clinical trials in Marietta, Georgia.

Sponsor
Life University
Study ID
NCT07779889
Status
Not Yet Recruiting

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Conditions

  • Neurodevelopmental Disorders
  • Social Behavior Disorders

Eligibility Criteria

Sex
ALL
Age
8 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Melillo Method — PROCEDURE
    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

Study Details

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.

Key Dates

First listed
Aug 21, 2026
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
34 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Immediate-start
    Participants in this arm will receive \~24 weeks (3x week) of Melillo Method therapy
  • Active Comparator: Delayed-start
    Participants in this arm will be allocated to a waitlist followed by \~12 weeks (3x week) of Melillo Method therapy

Primary Outcome Measure

Proportion of consenting parents [ Time Frame: Through study completion (up to 10 months) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Life UniversityMariettaGeorgia30060-
North Greene School DistrictRoodhouseIllinois62082
Site Principal Investigator
[email protected]
217-942-6562

Find similar trials in Marietta, GA

By research site
Life University· Marietta, GANorth Greene School District· Roodhouse, IL

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