NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

Not Yet RecruitingNA

Sponsor: Life University

Conditions: Social Behavior Disorders, Neurodevelopmental Disorders

Interventions: Melillo Method

Countries: United States

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 overview

Sex: ALL

Age: 8 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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)

Locations (2)

Marietta, Georgia, United States
Roodhouse, Illinois, United States