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OpenTrials
Completed

NCT Number: NCT06477575

Effectiveness of Technology-based Interventions for the Improvement of Cognitive Processes in ADHD.

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

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Key information

Conditions

ADHD, Deficits in Motor Control and Perception Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Berta Caro Puértolas

Badajoz, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children and adolescents diagnosed with ADHD
  • Age: 6-17 years old

Exclusion criteria

  • Children and adolescents diagnosed with ADHD + ADD.
  • Age: under 6 years old or over 17 years old.
  • Other psychopharmacological treatments not specific for ADHD.

Treatment and study plan

neurocognitive therapy based on new technologies

Device

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).

conventional neurocognitive therapy

Other

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).

Primary outcomes

  1. WisC-V (Wechsler intelligence scale for children)

    Time frame: 8 weeks

    provides primary intelligence index scores that reflect intellectual functioning in different cognitive areas: verbal comprehension, visuospatial, fluid reasoning, working memory and processing speed.

  2. STROOP (Colors and Words Test)

    Time frame: 8 weeks

    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.

  3. CARAS-R(Difference perception test)

    Time frame: 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Extremadura

Other

Registry information

Official study title

Effectiveness of Technology-based Interventions for the Improvement of Cognitive Processes in Children and Adolescents With ADHD.

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 27, 2024
Registry last updated
Jun 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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