Video games-Optima Stimulation-attention problems-school age children-II

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General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

VOEAE-2

Scientific title:

Evaluation of the effectiveness of video games for attention intervention in school-age boys and girls

Secondary indentifying numbers:

N-D-SW-3.3-1

Issuing authority of the secondary identifying numbers:

Cuban Center for Neuroscience (CNEURO)

Source(s) of monetary or material support:

Cuban Center for Neuroscience (CNEURO), National Program for Neuroscience and Neurotechnology

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Reference number:

In process

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Caridad

Last name:

Hernandez Perez

Medical Specialty :

Pedagogical Science PhD.

Affiliation:

Pedagogical University “Enrique Jose Varona”

Postal address:

Av 29 and 102, Marianao

City:

Havana

Country:

Cuba

Zip Code:

11400

Telephone:

+53-72741476

Email address:

caridadhp@ucpejv.edu.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Havana, Seguidores de Camilo Elementary School, Marbelis Casas Santamaria. Bachelor of Education

Havana, Rubén Bravo Elementary School, Adolfo Tornes Tornes. Bachelor of Education

Havana, Marcelo Salado Elementary School, Yiseli Aguilar Arison. Bachelor of Education

Havana, Pedro Domingo Murillo Elementary School, Reina Villavicencio Nuñez. Bachelor of Education

Havana, Capitán San Luis Elementary School, Aliema Marquetti Coll. Bachelor of Psychology

Havana, Patricio Lumumba Elementary School, Rosa Ibis Hernandez Valdes. Bachelor of Education

Havana, República de Corea Elementary School, Giomar de la Caridad Alvarez Roldan. Bachelor in Computer Science

Havana, Manuel Ascunce Domenech Elementary School, Mercedes Echarte Martinez. Bachelor of Education

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

20/03/2023

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

attention problems and impulsivity

Health condition(s) code:

Attention Deficit Disorder with Hyperactivity

Problem Behavior

Intervention(s):

Group I (Experimental): Optimal Stimulation Software (two video games of the attention training module). Group II (Control): Participants will play two commercial video games for the same number of sessions and duration as the experimental group. Both groups will play on a 10-inch tablet with Android Operating System. The intervention consist of 30 training sessions of 30 minutes each (15 minutes per game), 5 weekly sessions during 6 weeks.

Intervention keyword:

Videojuegos

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Continuos Performance Test (CPT): - Number of correct reponses (values between 0 and 20) - Number of omission errors (values between 0 and 20) - Number of commission errors (values between 0 and 80) - Reaction time (average reaction time in seconds) All variables will be measured before the intervention, immediately after the intervention and 3 months later.

Key secondary outcomes:

Math fluency (raw score, values between 0 and 100) Text segmentation task( number of words correctly parsed) Behavior Rating Inventory of Executive Functioning: -Inhibition (T score, values between 0 and >90) -Change (T score, values between 0 and >90) - Planning and organizanize (T score, values between 0 and >90) All variables will be measured before the intervention, immediately after the intervention and 3 months later.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

7 years

Maximum age:

12 years

Inclusion criteria:

1- Age between 7-12 years old 2- Attending a mainstream elementary school 3- Been at risk of behavioral problems (classification 1 or 2) according to Risk Signs Questionnaire for Attention Deficit Hyperactivity Disorder (CSR-C) of Optima Pesquisa 4- Presenting with attention deficits: scores below the expected level in any variable according to Crowdford's test in the Simple and Complex Continuos Performance Test (Optima Evaluación) 5-Parents signed a written Informed Consent and chindren assent to particpate in the study.

Exclusion criteria:

1- Presenting with emotional disorders according to the semi-structured psychiatric interview Kiddie-SADS - Lifetime Version (K-SADS-PL). 2- Previous diagnosis of photosensitive epilepsy. 3- Diagnosis of neurological or sensory disorders that hinder the correct perception of the details of the game or the motor response necessary for its execution. 4- Score below the 10th percentile on the Raven's Colored Matrices test.

Type of population:

Children

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Active

Study design:

Parallel

Phase:

2

Target sample size:

128

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Yuniel

Last Name:

Romero Quintana

Specialty:

Psychology

Affiliation:

Cuban Center for Neuroscience (CNEURO)

Postal Address:

190 street #19818 b/ Ave. 25 and 27, Cubanacan, Playa

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

+53-72637100 ext: 321

Email :

yuniel@cneuro.edu.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Maria

Middle Name:

del Rosario

Last Name:

Torres Diaz

Specialty:

Psychology

Affiliation:

Cuban Center for Neuroscience (CNEURO)

Postal Address:

190 street #19818 b/ Ave. 25 and 27, Cubanacan, Playa

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

+53-72637170

Email :

rosario@cneuro.edu.cu

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

Institute of Basic and Preclinical Sciences "Victoria de Girón

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

30/11/2022

Postal address of Ethic Committee :

146 street #3102 Cubanacan, Playa, Havana, ZC 11600, Cuba

Telephone:

+53-72084114

Email:

joseacostasariego@gmail.com

About study completion

Section to complete the data related to the study completion.

Study completion date:

17/08/2023

Date of available results:

17/08/2024

Date of first publication:

17/08/2024

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000419

Date of Registration in Primary Registry:

15/03/2023

Record Verification Date:

2023/03/15

Next update date:

2024/03/15

Link to the spanish version:

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Video games-Optima Stimulation-attention problems-school age children-II

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