AzTrials
AzTrials

ADHDNCT04329663

Effectiveness of the Indonesian Computer-based Game

A study testing Indonesian computer-based game prototype in people with ADHD and Executive Function, run by Tjhin Wiguna at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 12 years
Conditions the study is for
ADHD, Executive Function
What is being tested?
Indonesian computer-based game prototype
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteIndonesia
Study dates
7 Nov 2017to 15 Dec 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • N/A

Trial locations and contacts

1 site in 1 country.

Indonesia1 site
  • dr. Cipto Mangunkusumo General Hospital

    Jakarta Pusat, DKI Jakarta, 10430

Other trials in Indonesia

About this study

Official title: Effectiveness of the Indonesian Computer-based Game Prototype Towards ADHD Clinical Symptoms and Executive Function: A Functional Magnetic Resonance Imaging-blood-oxygen-level-dependent Pilot Study

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.

Read the detailed description

This study had two phases and was designed as a mix-method study. The first step was an exploratory qualitative study, and the second was a quasi-experimental study without any control.

  1. First Phase On the first phase, study conducted by using qualitative explorative design to develop and create computer-based game with Indonesian content in order to increase working memory capacity. This phase was done by focus group discussion (FGD) approach which involve participation from Indonesian Game Laboratorium from Faculty of Computer Science of Binus University International; and child and adolescent psychiatrist from Department of Psychiatry dr Cipto Mangunkusumo General Hospital - Faculty of Medicine Universitas Indonesia, Jakarta. .
  2. Second Phase:

On the second phase of the study, it used ' the one group pre- and post-test' without control design which aims to prove that the predeveloped game has impact to executive function of the child and impact to DLPFC region of the brain. 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. Number of study's subject which needed on this research was obtained by using sample size table formula for clinical studies', with α = 0,05, β=0,2, 2-sided and consider that Δ (effect size) = 1 resulting that 10 subjects were needed. This formula was used because to date, similar study has not found or conducted ( training with game and imaging with fMRI BOLD)

Operational definition which used in this study are:

  1. ADHD (Attetion Deficit Hyperactivity Disorder) defines as neurodevelopmental disorder which marked by hyperactivity, impulsive behaviour and difficulty in concentrate which happens more often and severe compares to peer group from same age group. This disorder causes impairment and distress to the child and his/her family. Diagnosis of ADHD and exclusion of other mental disorder was conducted by trained child and adolescent psychiatrist which established by structured interview using MINI kids.
  2. Working memory deficit defines as deficit in ability to store and manipulate information for a short period of time and to be able to look upon, memorize, and take action on an information simultaneously. Clinical measuring of working memory deficit is done by BRIEF questionnaire which have been validated into Indonesion language 2011.
  3. Imaging with fMRI was conducted by special stimuli to stimulate child's executive function with go and no-go modification which were images that had to be memorized in accordance to specific order and truth of the image. fMRI was conducted at Radiology Unit, Abdi Waluyo Hospital, using MRI scanner from GE Health care, 3 Tesla, 8-channel-coil. Sequence which used was Echo Plannar Imaging (EPI), with some modification; TR 3 seconds, TE 30, bandwidth 250kHZ, FOV 240 x 240, slice thickness 3 mm, space 1 mm, matrix 84 x 84 (frequency x phase), NEX 1, total slices 36, time 312 seconds. The measuring would be changes in activity by imaging result of fMRI BOLD (blod Oxygen-Level Dependent Contrast), which the level will increase on the more active brain part and decrease on the less active brain part.

Data Analysis Qualitative data was analysed by qualitative approach and described in a form of text. Data analysis for quantitative study was conducted by 't' test analytic for variable dependent by SPSS version 21 for Mac.

Data from MRI result would undergo pre-processing process which are realignment, writing and smoothing with FHWM 8 mm, then processed with Statistical Parametric Mapping (SPM) software version 12 and CONN Toolbox version 17. Analysis method which conducted was ROI-to ROI method wth the chosen ROI for this studty were lef and right Dorsolateral Prefrontal Cortex and Hippocampus fucntional connectivity.

Being tested
Indonesian computer-based game prototype
Keywords
Indonesia, computer-based game, executive function, ADHD, BRIEF, CATPRS, Primary school children
Medical subject headings
Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Indonesian computer-based game prototypeDevice

    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.

Study groups in NCT04329663
Study groupRoleWhat they receive
training groupExperimentalTen 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
Receives: Device: Indonesian computer-based game prototype

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 5 - 10 minutes

  2. 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

    Measured: 5 - 10 minutes

  3. executive function

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

    Measured: 15 - 20 minutes

  4. DLPFC-Hippocampus functional connectivity

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

    Measured: 20 - 30 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2020
  2. Study start7 Nov 2017
  3. Primary completion15 Dec 2017
  4. Study completion15 Dec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04329663
Sponsor's protocol ID
Indonesian computer-based game
Status last verified
Mar 2020
First submitted
30 Mar 2020
Last updated
2 Apr 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Study protocol

Questions about this trial

What is this clinical trial studying?

A study testing Indonesian computer-based game prototype in people with ADHD and Executive Function, run by Tjhin Wiguna at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ADHD clinical symtpoms-parent rating (time frame: 5 - 10 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2020.

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