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.
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
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.
- 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. .
- 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:
- 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.
- 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.
- 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.
- Conditions
- ADHD, Executive Function
- 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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Indonesian computer-based game prototype |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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
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.
- First posted1 Apr 2020
- Study start7 Nov 2017
- Primary completion15 Dec 2017
- Study completion15 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Tjhin Wiguna
- Sponsor type
- University, hospital or other
- Collaborators
- Dr Cipto Mangunkusumo General Hospital, Fakultas Kedokteran Universitas Indonesia, Binus University International
- Responsible party
- Sponsor-investigator, Tjhin Wiguna, Dr Cipto Mangunkusumo General Hospital
- Investigators
- Tjhin Wiguna, PhD, Principal investigator, Dr Cipto Mangunkusumo General HospitalTjhin Wiguna, PhD, Principal investigator, Fakultas Kedokteran Univeristas Indonesia
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04329663
- Acronym / sponsor ID
- Indonesian computer-based game
- Conditions
- ADHD, Executive Function
- Keywords
- Indonesia, computer-based game, executive function, ADHD, BRIEF, CATPRS, Primary school children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Tjhin WigunaUniversity, hospital or other
- Collaborators
- Dr Cipto Mangunkusumo General Hospital, Fakultas Kedokteran Universitas Indonesia, Binus University International
- Study start
- 7 Nov 2017 (actual)
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 15 Dec 2017 (actual)
- First posted
- 1 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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. .
- 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:
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| training group | Experimental | Device: Indonesian computer-based game prototypeTen 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 |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indonesian computer-based game prototypeIn 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. | Device | training group |
Primary outcome
ADHD clinical symtpoms-parent rating
Time frame: 5 - 10 minutes
Connors' Abbreviated Parent Teacher Rating Scale. The total lower score lower score is 0 and the higher total score is 30
ADHD clinical symtpoms-teacher rating. The total lower score lower score is 0 and the higher total score is 30
Time frame: 5 - 10 minutes
Connors' Abbreviated Parent Teacher Rating Scale
executive function
Time frame: 15 - 20 minutes
Behavior Rating Inventory of Executive Function (BRIEF). The raw data is transformed into the Tscore. The anaylsis using the Tscore
DLPFC-Hippocampus functional connectivity
Time frame: 20 - 30 minutes
functional Magnetic Resonance Imaging Brain Oxygen Dependent Level. The functional connectivity is generated from the Conn toolsbox ans SPM 12.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2020.
- Individual participant dataSharing planned: No. Study protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tjhin Wiguna, PhD principal investigator
Dr Cipto Mangunkusumo General Hospital
Tjhin Wiguna, PhD principal investigator
Fakultas Kedokteran Univeristas Indonesia
1 site in 1 country: see every site and its status.
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.