N/A
Completed N=32
A Novel, Non-pharmacological, Intervention for the Management of ADHD in Adolescents
Source: ClinicalTrials.gov NCT05835336 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcomePrimary: Change in the ADHD Rating Scale (ADHD-RS) Parent-report Questionnaire - Total Score - at Baseline and 2 Months Follow up — 30.30; 22.85 score on a scale — p=<0.001
Summary
This is a 2-month study in which eligible ADHD adolescents will be provided with personalized VIZO Glasses
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the ADHD Rating Scale (ADHD-RS) Parent-report Questionnaire - Total Score - at Baseline and 2 Months Follow up |
30.30; 22.85 | <0.001 sig |
| PRIMARY Change in the ADHD Rating Scale (ADHD-RS) Parent-report Questionnaire - Inattentiveness Subscale - at Baseline and 2 Months Follow up |
18.00; 14.10 | <0.001 sig |
| PRIMARY Change in the ADHD Rating Scale (ADHD-RS) Parent-report Questionnaire - Hyperactivity-Impulsivity Subscale - at Baseline and 2 Months Follow up |
12.30; 8.75 | 0.001 sig |
| PRIMARY Change in Behavior Rating Inventory of Executive Function (BRIEF) - Metacognitive Index - at Baseline and 2 Months Follow up |
107.89; 102.74 | 0.032 sig |
| SECONDARY Clinical Global Impression-Improvement (CGI-I) - at 2 Months Follow up |
21; 1 | — |
| SECONDARY Change in Behavior Rating Inventory of Executive Function (BRIEF) - Global Executive Composite - at Baseline and 2 Months Follow up |
161.47; 153.89 | 0.035 sig |
| SECONDARY Change in Conners' Continuous Performance Test-3 (CPT-3) - Detectability (d') at Baseline and 2 Months Follow up |
50.55; 51.68 | .521 |
Eligibility Criteria
Inclusion Criteria
- Documented history of primary ADHD diagnosis by certified clinicians
- Age 12-17 y
- Minimum total of 24 on the parent ADHD-IV Rating Scale (ADHD-RS)
- Written informed consent
- Able and willing to complete all required ratings and assessments
Exclusion Criteria
- Any current psychiatric/neurological comorbidity (e.g., epilepsy, Autism, depression, TBI, etc.), other than ADHD
- ADHD Medications (stimulants, non-stimulants, other)
- Undergoing Neurofeedback, cognitive training
Data sourced from ClinicalTrials.gov (NCT05835336). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.