NCT06477575

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 27, 2024

Completed
Last Updated

June 27, 2024

Status Verified

June 1, 2024

Enrollment Period

19 days

First QC Date

June 21, 2024

Last Update Submit

June 21, 2024

Conditions

Keywords

ADHDcognitive rehabilitationnew technologies

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

EXPERIMENTAL
Device: neurocognitive therapy based on new technologies

conventional neurocognitive therapy

ACTIVE COMPARATOR
Other: conventional neurocognitive therapy

Interventions

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).

neurocognitive therapy based on new technologies

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).

conventional neurocognitive therapy

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

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

Locations