Effectiveness of the Indonesian Computer-based Game
Condition: ADHD; Executive Function
Study type: Interventional

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.
    

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.
    

Intervention name(s): Indonesian computer-based game prototype
Intervention type(s): Device
Intervention description(s): 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.
Intervention model: Single Group Assignment
Intervention 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)
Primary purpose: Device Feasibility
Keywords: Indonesia, computer-based game; executive function; ADHD; BRIEF; CATPRS; Primary school children