ADHD Clinical Trial
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.
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.
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