Effectiveness of Technology-based Interventions for the Improvement of Cognitive Processes in ADHD.
1 other identifier
interventional
40
1 country
1
Brief Summary
To scientifically demonstrate the improvements in cognitive functions and core symptoms of children and adolescents diagnosed with ADHD through the implementation of a cognitive rehabilitation program based on the use of the most relevant technologies found in the systematic review carried out during the first phase. Two intervention groups will be randomly assigned for the study: G1: composed of 20 patients who will receive neurocognitive therapy based on new technologies. This will be the experimental group. G2: composed of 20 patients who will receive conventional neurocognitive therapy for ADHD treatment. This group will be the control group
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2024
CompletedFirst Submitted
Initial submission to the registry
June 21, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 21, 2024
CompletedFirst Posted
Study publicly available on registry
June 27, 2024
CompletedJune 27, 2024
June 1, 2024
19 days
June 21, 2024
June 21, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
WisC-V (Wechsler intelligence scale for children)
provides primary intelligence index scores that reflect intellectual functioning in different cognitive areas: verbal comprehension, visuospatial, fluid reasoning, working memory and processing speed.
8 weeks
STROOP (Colors and Words Test)
reference test for the detection of neuropsychological problems and brain damage. It allows to evaluate the phenomenon of interference, intimately linked to inhibitory control processes.
8 weeks
CARAS-R(Difference perception test)
evaluates the ability to quickly and correctly perceive similarities and differences in partially ordered patterns of stimulation. It measures perceptual and attentional skills by means of 60 graphic items consisting of schematic drawings of faces with elementary strokes.
8 weeks
Study Arms (2)
neurocognitive therapy based on new technologies
EXPERIMENTALconventional neurocognitive therapy
ACTIVE COMPARATORInterventions
The cognitive neurorehabilitation program is based on gaming through the use of the Nintendo Switch device. The following games have been chosen: Pufferfish, Hex Egg, Mystic Totem, Thor's Thunder, since they are games that work on selective attention, concentration and processing speed, which are the variables to be studied in this project. Hardware: Nintendo Switch Software: 60 in 1 game Games: Pufferfish, Hex Egg, Mystic Totem, Thor's Thunder. Therapy time: 30 minutes effective. Number of Sessions: 2 per week / Number of weeks: 8 Total number of intervention sessions: 16 sessions Place: Thercli Center (Don Benito).
The cognitive neurorehabilitation program for group active comparator is based on playing more conventional board games that work on selective attention, concentration and processing speed, which are the variables to be studied in this project. Traditional games and token book. Games: Dobble, Lynx, Crazy cups, Jungle speed, animalea, ghost. Card: Stimulate and learn level 3 and 4. Therapy time: 30 minutes effective. No. of sessions: 2 per week / No. of weeks: 8 Total number of intervention sessions: 16 sessions Place: Thercli Center (Don Benito).
Eligibility Criteria
You may qualify if:
- Children and adolescents diagnosed with ADHD
- Age: 6-17 years old
You may not qualify if:
- Children and adolescents diagnosed with ADHD + ADD.
- Age: under 6 years old or over 17 years old.
- Other psychopharmacological treatments not specific for ADHD.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Berta Caro Puértolas
Badajoz, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Proffesor
Study Record Dates
First Submitted
June 21, 2024
First Posted
June 27, 2024
Study Start
March 1, 2024
Primary Completion
March 20, 2024
Study Completion
June 21, 2024
Last Updated
June 27, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share