Effectiveness of the Indonesian Computer-based Game

NCT04329663 | Completed

• 1 other identifier: Indonesian computer-based game
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to develop an Indonesian computer-based game prototype that targets the clinical symptoms of ADHD as well as executive function and to investigate effectiveness through fMRI BOLD examination. This was a mix-method study design; the first step was an exploratory qualitative study using focused group discussion. The second step was 'the one group pre- and post-test design study' without any control. Ten primary school children who were drug-naïve and had a diagnosis of ADHD with no other mental or physical disorders participated in the study. Clinical improvement was measured by the CATPRS, BRIEF, and fMRI BOLD examination that focused on DLPFC-Hippocampus functional connectivity before and after 20 sessions of the Indonesian computer-based game prototype training. Data were analyzed using the paired t test and Pearson's correlation in SPSS for Mac version 21, and fMRI BOLD functional analysis was performed using SPM software version 12 and CONN Toolbox version 17. The hypothesis was: the Indonesian computer-based game prototype had an effect towards ADHD clinical symptoms and executive function that correlated with DLPFC-Hippocampus functional connectivity.

Conditions

ADHD; Executive Function

Keywords

Indonesia, computer-based game; executive function; ADHD; BRIEF; CATPRS; Primary school children

Outcome Measures

Primary Outcomes (4)

• ADHD clinical symtpoms-parent rating

  Connors' Abbreviated Parent Teacher Rating Scale. The total lower score lower score is 0 and the higher total score is 30

  5 - 10 minutes

• ADHD clinical symtpoms-teacher rating. The total lower score lower score is 0 and the higher total score is 30

  Connors' Abbreviated Parent Teacher Rating Scale

  5 - 10 minutes

• executive function

  Behavior Rating Inventory of Executive Function (BRIEF). The raw data is transformed into the Tscore. The anaylsis using the Tscore

  15 - 20 minutes

• DLPFC-Hippocampus functional connectivity

  functional Magnetic Resonance Imaging Brain Oxygen Dependent Level. The functional connectivity is generated from the Conn toolsbox ans SPM 12.

  20 - 30 minutes

Study Arms (1)

training group

EXPERIMENTAL

Ten children with ADHD who got the 20 sessions training of the Indonesian computer-based game prototype. They we were assessed by CATPRS, BRIEF and fMRI BOLD

Device: Indonesian computer-based game prototype

Interventions

Indonesian computer-based game prototype DEVICE

In order to improve the ADHD clinical symptoms and executive function of the player, this game should has challenge similar to memory game which is the player was given object to be memorized and then match the object in accordance to the task given inside the game. With some difficulty leves, this game was tried to trigger players in terms of accuracy and quickness in completing the mission.

training group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children with ADHD diagnosis
• Aged 6 to 12 years who were drug-naïve prior to the study, does not have any other mental or physical chronic illnesses, and willing to undergo the Indonesian computer-based game prototype training for 20 sessions with approximately 30 minutes per session over 4 weeks consecutively

You may not qualify if:

• N/A

Sponsors & Collaborators

• Tjhin Wiguna: lead
• Dr Cipto Mangunkusumo General Hospital: collaborator
• Fakultas Kedokteran Universitas Indonesia: collaborator
• Binus University International: collaborator

Study Sites (1)

dr. Cipto Mangunkusumo General Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Tjhin Wiguna, PhD

  Dr Cipto Mangunkusumo General Hospital

  PRINCIPAL INVESTIGATOR

• Tjhin Wiguna, PhD

  Fakultas Kedokteran Univeristas Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. dr.

Model Details: The inclusion criteria was child with ADHD age 5 to 12 years old that never taken medication prior to the study and willing to undergo training with computer based game which developed from phase one of the study for about 20 sessions with approximately 30 minutes per each session for 4 weeks consecutively. The training was conducted at school where the sample attended school so it would not disturb the learning and teaching process at school. The training would be guided and supervised directly by the researcher team. The diagnosis of ADHD was conducted by trained child and adolescent psychiatrist guided by Mini-Kids which was structured interview guide built based on ICD-X. Children which included on the study were child with ADHD without any other mental disorder comorbidity and does not has chronic physical illness during the interview with the parents. Child which does not complete 90% of the numbers of the training that planned will not included in data analysis.

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: April 1, 2020
• Study Start: November 7, 2017
• Primary Completion: December 15, 2017
• Study Completion: December 15, 2017
• Last Updated: April 2, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)