Recruiting

Melillo Method

Sponsor:

Life University

Code:

NCT07779889

Conditions

Social Behavior Disorders

Neurodevelopmental Disorders

Eligibility Criteria

Sex: All

Age: 8+

Healthy Volunteers: Not accepted

Interventions

Melillo Method

Study Details

Brief summary:

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.

Conditions

Social Behavior Disorders

Neurodevelopmental Disorders

Study ID

NCT07779889

Start date

Sep 15, 2026

Status verified date

Sep, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

34 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Melillo Method

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

Primary outcome measure

  • Proportion of consenting parents [ Time Frame: Through study completion (up to 10 months) ]
  • Proportion Strength and Difficulties Questionnaire - Teacher version (SDQ-T) completed [ Time Frame: Through study completion (up to 10 months) ]
  • Proportion Strength and Difficulties Questionnaire - Parent version (SDQ-P) completed [ Time Frame: Through study completion (up to 10 months) ]
  • Proportion of completed assessment batteries [ Time Frame: Through study completion (up to 10 months) ]
  • Proportion of students adhering to the care plan [ Time Frame: Through study completion (up to 10 months) ]
  • Proportion of students retained in the immediate-start arm [ Time Frame: Through study completion (up to 10 months) ]
  • Proportion of students retained in the delayed-start arm. [ Time Frame: Through study completion (up to 10 months) ]

Central Contacts and Locations

Central contacts

Associate Vice President of Research

678-331-4527research.studies@life.edu

Locations

North Greene School District

Recruiting

Roodhouse, Illinois, United States, 62082

Contacts

Site Principal Investigator

217-942-6562avandersand@boydhcs.org

More Information

Sponsor

Life University

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Keywords

  • Pilot Projects
  • Pediatrics
  • Melillo Method

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Life University on 2026-09-08.