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

June 21, 2024 updated by: Alejandro Caña Pino, University of Extremadura

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Badajoz, Spain
        • Berta Caro Puértolas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: neurocognitive therapy based on new technologies
Device: neurocognitive therapy based on new technologies

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).
Active Comparator: conventional neurocognitive therapy
Other: conventional neurocognitive therapy

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks
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.
8 weeks
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.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Extremadura

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Actual)

March 20, 2024

Study Completion (Actual)

June 21, 2024

Study Registration Dates

First Submitted

June 21, 2024

First Submitted That Met QC Criteria

June 21, 2024

First Posted (Estimated)

June 27, 2024

Study Record Updates

Last Update Posted (Estimated)

June 27, 2024

Last Update Submitted That Met QC Criteria

June 21, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 210624

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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