An interventional study of Melillo Method in Social Behavior Disorders and Neurodevelopmental Disorders, sponsored by Life University. Recruiting at 1 site in United States. Open to participants aged 8 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Life University · Not applicable, Interventional, and Treatment
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.
Scientific Rationale The intervention under study, the Melillo Method® (MM), is grounded in a "functional disconnection syndrome" model proposing that pediatric neurodevelopmental challenges arise from insufficient temporal synchronization and functional connectivity between brain hemispheres. This model builds on evidence that retained primitive reflexes - brainstem-mediated motor patterns typically inhibited through cortical maturation in infancy - are associated with impaired postural control, motor coordination difficulties, attentional challenges, and behavioral dysregulation when they persist beyond early childhood. MM applies individualized, lateralized sensory-motor stimulation intended to target the functionally weaker hemisphere, with the aim of supporting primitive reflex inhibition and neural maturation. This approach is consistent with experience-dependent neuroplasticity models. While MM has an established base of clinical observation, it has not previously been evaluated using a randomized controlled design in a school-based pediatric population; this trial addresses that methodological gap.
Design Rationale A delayed-start (waitlist-control) design was selected to balance the ethical goal of providing intervention access to a likely clinical population against the methodological need to control for natural maturation and regression to the mean. All enrolled students eventually receive the intervention, while the delayed-start arm provides a stable non-intervention comparison period.
Allocation uses a minimization (covariate-adaptive) procedure rather than simple randomization, balancing on school level (elementary vs. middle school) as the sole minimization factor. School level was selected because the structural and environmental transition into early adolescence is understood to be a predominant driver of fluctuations in student well-being, cognitive engagement, and emotional functioning, independent of chronological age. Limiting minimization to a single, biologically justified factor follows recommended practice for small trials, since stratifying on multiple factors can degrade balancing efficiency and increase the predictability of upcoming allocations, introducing risk of selection bias. Allocation is performed using a password-protected, web-based system (QMinim) that conceals allocation until randomization, using a biased-coin probability method (base probability 0.8) with marginal balance distance weighting.
Because the screening instrument also serves as a primary outcome measure, a second (run-in) administration is obtained after screening but prior to randomization, and this second administration - not the screening score - serves as the analytic baseline. This approach mitigates regression-to-the-mean and initial-elevation bias that can otherwise inflate apparent treatment effects when a single instrument is used for both eligibility screening and outcome measurement.
Intervention Delivery Model The intervention is delivered by a Melillo Method-certified clinician and a trained assistant in dyadic (n=2) small-group format, three sessions weekly, over each participant's assigned 12- or 24-week course. 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 and vestibular exercises delivered during each session.
Programmatic Evaluation Component Running in parallel with the RCT, a mixed-methods programmatic evaluation uses a volunteer advisory committee and structured stakeholder interviews/surveys (administrators, teachers, parents) at three timepoints to iteratively inform trial implementation and to generate qualitative data supporting the design of a future, adequately powered efficacy trial.
Statistical Approach to Feasibility Sample size and progression thresholds were determined using contemporary pilot/feasibility trial methodology (SS-PROGRESS), targeting ≥90% power to reject the "red/stop" zone for each feasibility outcome under the assumption that the "green/go" zone holds true, using investigator-specified minimal and hypothesized values for each outcome. This approach follows current recommendations for defining objective, pre-specified go/no-go criteria in pilot trials rather than relying on point estimates alone.
Exclusion Criteria:
Participants in this arm will receive \~24 weeks (3x week) of Melillo Method therapy
Procedure: Melillo Method
Participants in this arm will be allocated to a waitlist followed by \~12 weeks (3x week) of Melillo Method therapy
Procedure: 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
Also known as: Functional Neurology
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: Through study completion (up to 10 months)
Proportion Strength and Difficulties Questionnaire - Teacher version (SDQ-T) completed
The number of SDQ-T surveys completed, divided by the total number of SDQ-T surveys sent. This assesses teacher-level 'Response'
Time frame: Through study completion (up to 10 months)
Proportion Strength and Difficulties Questionnaire - Parent version (SDQ-P) completed
The number of SDQ-T surveys completed, divided by the total number of SDQ-T surveys sent. This assesses parent-level 'Response'
Time frame: Through study completion (up to 10 months)
Proportion of completed assessment batteries
The number of completed assessment batteries, divided by the total number of attempted assessment batteries. This assesses 'Tolerability'
Time frame: Through study completion (up to 10 months)
Proportion of students adhering to the care plan
The number of enrolled students attending at least 90% of their scheduled therapy sessions, divided by the total number of students attending therapy (excludes sessions scheduled after withdrawal). This assesses 'Adherence'
Time frame: Through study completion (up to 10 months)
Proportion of students retained in the immediate-start arm
The number of students allocated to the immediate-start arm attending the end-trial assessment session, divided by the total number of students allocated to the immediate-start arm. This assesses experimental arm 'Retention'
Time frame: Through study completion (up to 10 months)
Proportion of students retained in the delayed-start arm.
Number of students in the delayed-start arm attending the end-trial assessment session divided by the total number of students allocated to the delayed-start arm. This assesses control-arm 'Retention'
Time frame: Through study completion (up to 10 months)
Change difference in NIH Toolbox (v3) Cognition Battery Composites
Between-group change differences in the NIH Toolbox (v3) cognition battery composite scores. Recommended for ages 7+, the cognition battery involves a series of engaging and challenging cognitive tasks which yield the following summary age-adjusted standard scores (M=100, SD=15): 1) Total Cognition Composite, 2) Fluid Composite = Dimensional Change Card Sort + Flanker Inhibitory Control and Attention + Picture Sequence Memory + List Sorting Working Memory + Pattern Comparison Processing Speed, and 3) Crystallized Composite = Picture Vocabulary + Oral Reading Recognition.
Time frame: Through study completion (up to 10 months)
Change difference in NIH Toolbox (v3) Emotion Battery Composites
Between-group change differences in the NIH Toolbox (v3) emotion battery composite scores. Recommended for ages 8+, the emotion battery provides a multidimensional assessment of emotional health across four theoretical domains: 1) Negative Affect, 2) Psychological Well-Being, 3) Social Relationships, and 4) Stress and Self-Efficacy. This battery incorporates Computer Adaptive Testing (CAT) based on Item Response Theory to dynamically select items tailored to each child's responses. This adaptive framework ensures high measurement precision across the entire ability spectrum, effectively eliminating 'floor and ceiling' effects while minimizing participant burden. Age- and sex-corrected subscale T-scores (M=50, SD=10), automatically generated by the NIH Toolbox v3 app, will be combined to derive four higher-order composites: 1) Negative Affect, 2) Psychological Well-Being, 3) Negative Social Perception, and 4) Social Satisfaction.
Time frame: Through study completion (up to 10 months)
Change difference in the NIH Toolbox (v3) 9-hold Pegboard Dexterity Test
Between-group change differences in the NIH Toolbox (v3) 9-hold pegboard dexterity test. This assessment of fine motor control requires students to pick up 9 pegs from a container, place them into 9 corresponding holes on a board, and then remove them as quickly as possible. The task is performed twice, once with the dominant hand and once with the non-dominant hand. The raw score, measured as the total time in seconds taken to complete the task for each hand, is converted into an age-adjusted standard score (M=100, SD=15) based on national norms.
Time frame: Through study completion (up to 10 months)
Change difference in the Strengths & Difficulties Questionnaire - Parent (SDQ-P)
Between-group change difference in the SDQ-P. The SDQ is a validated, brief (25-item) instrument normed for children (ages 4-10) and adolescents (ages 11-17) that assesses five subscales: Emotional Symptoms, Conduct Problems, Hyperactivity/Inattention, Peer Problems, and Prosocial Behavior \[19\]. Each item is scored on a 3-point Likert scale (0 = 'Not True', 1 = 'Somewhat True', 2 = 'Certainly True'). The 20 items from the four problem-oriented subscales are summed to yield a Total Difficulties Score (0 to 40). The remaining 5 items comprise the Prosocial Behavior subscale, which is scored independently (0 to 10) to provide a standalone measure of positive social assets.
Time frame: Through study completion (up to 10 months)
Change difference in the Strengths & Difficulties Questionnaire - Teacher (SDQ-T)
Between-group change difference in the SDQ-T. The SDQ is a validated, brief (25-item) instrument normed for children (ages 4-10) and adolescents (ages 11-17) that assesses five subscales: Emotional Symptoms, Conduct Problems, Hyperactivity/Inattention, Peer Problems, and Prosocial Behavior \[19\]. Each item is scored on a 3-point Likert scale (0 = 'Not True', 1 = 'Somewhat True', 2 = 'Certainly True'). The 20 items from the four problem-oriented subscales are summed to yield a Total Difficulties Score (0 to 40). The remaining 5 items comprise the Prosocial Behavior subscale, which is scored independently (0 to 10) to provide a standalone measure of positive social assets.
Time frame: Through study completion (up to 10 months)
Plan to share: Yes — Deidentified IPD necessary to reproduce results.
Supporting information: Analytic code
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