Evaluation of Sustained Endogenous Attention Deficits in Attention Deficit Hyperactivity Disorder: Validation of a Computerized Neuropsychological Test."
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Performances on Sustained-Paced Finger Tapping test
Study Overview
Brief Summary
Subjects with ADHD may exhibit deficits in sustained internal attention. The "Sustained-Paced Finger Tapping" test was recently developed and experimentally used in international literature to assess sustained internal attention in typically developing children. This clinical study has several objectives: 1) to assess the presence of "internal" sustained attention deficits in children with ADHD through the "Sustained-Paced Finger Tapping"; 2) to evaluate the discriminant and ecological validity of the "Sustained-Paced Finger Tapping."
Detailed Description
Recently, a distinction has been recognized between external sustained attention and internal sustained attention. Internal sustained attention is defined as the ability to maintain attention over time on neurocognitive processes that, rather than processing external information, act on information stored in memory. The "Sustained-Paced Finger Tapping" test was developed and used in experimental research protocols in international literature to assess internal sustained attention in typically developing children. While numerous studies confirm that ADHD is associated with deficits in external sustained attention, the international literature emphasizes that internal attention has been underexplored in ADHD. A pilot study conducted by the University of Salento revealed preliminary data showing that children with ADHD exhibit significantly lower performance compared to control subjects in the "Sustained-Paced Finger Tapping." Despite these preliminary data suggesting that the "Sustained-Paced Finger Tapping" test has the ability to discriminate between children with and without ADHD, there are no published studies formally investigating this hypothesis. Two subject samples will be recruited: one sample of subjects with ADHD and one sample of subjects without ADHD and with typical development. The ADHD diagnosis will be made based on the concordance of four data sources: 1) the detection of diagnostic criteria indicated in the DSM-5 through interviews, medical history, and observation during a neuropsychiatric and psychological visit; 2) high and/or medium-high scores, i.e., ≥ 65/70 T, on the ADHD symptom subscales of both the Conners-3-Parent and the CBCL-Parent; 3) high and/or medium-high scores, i.e., ≥ 65/70 T, on the ADHD symptom subscales of at least one questionnaire (Conners-3 or CBCL) administered to teachers; 4) the presence of all DSM-5 symptoms for ADHD on the Conners-3 scale for both parents and teachers.
Inclusion criteria:
ADHD Group:
Subjects with a diagnosis of ADHD (of any severity level and subtype) aged between 6 and 10 years; "Medication-naive" ADHD subjects, i.e., subjects who have not been prescribed and/or have not yet started taking any medication for ADHD; IQ ≥ 70.
Non-ADHD Group:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 13 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •ADHD Group (1) Subjects with a diagnosis of ADHD of any severity level and subtype
- •ADHD Group (2) "Medication-naive" ADHD subjects, meaning subjects who have not been prescribed and/or have not yet started any pharmacological treatment for ADHD
- •ADHD Group (3) IQ ≥ 70
- •Non-ADHD Group, Normal IQ
Exclusion Criteria
- •for both groups, symptomatology suggestive of autism spectrum disorders, psychotic disorders, mood disorders, and anxiety disorders
- •for both groups, use of psychotropic drugs
- •for both groups, subjects with cerebral palsy and/or neuromotor and neuromuscular disorders
- •for both groups, CNS diseases, e.g., epilepsy and/or neurodegenerative diseases, or central nervous system injuries resulting from, for example, head trauma or stroke
- •for the non-ADHD group, presence of ADHD symptoms
Arms & Interventions
ADHD group and Control Group
The same neuropsychological test (i.e.Sustained-Paced Finger Tapping) is administered to two groups of subjects: one group of subjects with ADHD and one group of typically developing subjects. Sustained-Paced Finger Tapping" (Petilli et al., 2018) is a computerized test that lasts approximately 10 minutes. It involves maintaining and reproducing the rhythm of a sound (auditory version) .
Intervention: Sustained-Paced Finger Tapping" (Petilli et al., 2018) (Diagnostic Test)
Outcomes
Primary Outcomes
Performances on Sustained-Paced Finger Tapping test
Time Frame: baseline
Both groups of subjects (i.e. ADHD group and Control Group) will be administered the "Sustained-Paced Finger Tapping" (Petilli et al., 2018). It is a computerized test that lasts approximately 10 minutes. It consists of maintaining and reproducing for a certain period of time (10 minutes) the rhythm of a sound presentation (auditory version).
Secondary Outcomes
No secondary outcomes reported