Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000754145
Ethics application status
Approved
Date submitted
29/03/2019
Date registered
21/05/2019
Date last updated
21/05/2019
Date data sharing statement initially provided
21/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Diagnostic Predictive Modelling of Attention Deficit Hyperactivity Disorder: Accuracy of Spatiotemporal Fractal Measures
Scientific title
Diagnostic Predictive Modelling of Attention Deficit Hyperactivity Disorder: Accuracy of Spatiotemporal Fractal Measures
Secondary ID [1] 297834 0
None
Universal Trial Number (UTN)
U1111-1227-4819
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attention Deficit Hyperactivity Disorder (ADHD) 312205 0
Condition category
Condition code
Mental Health 310749 310749 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a prospective, cross-sectional case-control study. Children between the ages of 5-12 will be taken to the study as a case and control group, and the game will be performed together with the questionnaires.
The case group consisted of 54 children (18 ADHD combined, 18 ADHD Inattentive, 18 ADHD Hyperactive), aged between 5 and 12 years, who were admitted to the Pediatric Psychiatry Outpatient Clinic for the first time. The case group will be newly diagnosed, previously untreated.
Participants and the parents of them will be informed in detail about the study.
After the clinical interview, the Conners' ADHD Rating Scale will be applied to the parents of children who have agreed to participate in the study and who have been informed in written and orally. The Battleship will be played on the computer for 20-40 minutes. Researchers will teach the children to play the game. After the children learn how to play the game, the game will be played by the children without any help. The player will play the game alone. The player will not be a competitor against the player or another player. When the game is completed, children will be able to learn their score. At the end of each game, the child will be asked if he or she would like to play another game. The children will play eight times the game. The total testing duration will be approximately 20-40 min; including one break after the fourth game. During the task completion the child will receive visual feedback (in the computer screen) about the number of shots already performed, time passed, and their ongoing performance (amount of sunk ships. After finishing the interview an archive file will be created for each participant containing the data coming from the computer game Battleship.
The Battleship: The game will attempt to discover four ships of different lengths stored as "battleships". You need to choose a frame to make a move. In any move a warning appears saying that he "missed" a ship, or "found" the ship. The total number of movements for each game played is saved to the computer. Then, for each game, a graph will be created to show the player's motion model. Each player has a different movement pattern.
Intervention code [1] 314071 0
Diagnosis / Prognosis
Comparator / control treatment
In the control group, 18 healthy children between the ages of 5 and 12 who are admitted to the Pediatric Outpatient Clinic and do not have the acute or chronic active disease will be included. The same protocol will be applied to the control group.
Control group
Active

Outcomes
Primary outcome [1] 319607 0
The Primary Outcome Measures of attention are the Total number of shots performed to solve the problem, their (x,y) coordinates and time between shots.
i A graph will be generated with the sequence of (x,y) coordinates of each shot fired to solve the problem;
ii Multifractal and Lacunarity spectrum along with other geometrical measures (biomarkers) will be estimated from the resulting graph.
Timepoint [1] 319607 0
Immediately after completion of interview and problem-solving task by each participant
Secondary outcome [1] 368846 0
Result of ADHD diagnostic coming from: Conners 3rd edition and DSM-IV-TR diagnostic interview.
Timepoint [1] 368846 0
Immediately after completion of interview and problem-solving task by each participant

Eligibility
Key inclusion criteria
Inclusion criteria for the case groups
DSM-V ADHD diagnosis including predominantly Inattentive, predominantly Hyperactive-Impulsive, and Combined types
Conners’ Rating Scale scores implying ADHD
Drug-naive patients; that never used any psychoactive drug or received any psychoactive therapy.
Diagnosed for the first time.

Inclusion criteria for the control group:
No DSM-V ADHD diagnosis including predominantly Inattentive, predominantly Hyperactive-Impulsive, and Combined types
No Conners’ Rating Scale scores implying ADHD
Minimum age
5 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria for the case group:
Any history of medical disorder or psychiatric disorder other than ADHD.
Old Diagnosis of ADHD.
Drug usage for ADHD.

Exclusion criteria for controls:
Any history of medical or psychiatric disorder.
DSM-V ADHD diagnosis.
Conners’ Rating Scale scores implying ADHD.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Conners' ADHD Rating Scale scores will be calculated for patients and the scores will be compared according to age and gender; t test or ANOVA test will be applied. When comparing scale scores, Pearson Correlation analysis will be applied to normal distributed data according to normality test, Spearman Correlation analysis will be applied to non-normally distributed data. By comparing the movement models obtained from the game of both groups, the difference between them will be investigated and the predictors of ADHD diagnosis will be determined.
Fractal analysis allows the mathematical expression of irregular and complex states. In this study, the spatiotemporal data obtained from the participants' movements during the play will be interpreted with the help of fractal analysis and the game will be investigated to predict ADHD diagnosis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment outside Australia
Country [1] 21379 0
Turkey
State/province [1] 21379 0
Ankara

Funding & Sponsors
Funding source category [1] 302356 0
Self funded/Unfunded
Name [1] 302356 0
Hakan Ögütlü
Country [1] 302356 0
Turkey
Primary sponsor type
Individual
Name
Hakan Ögütlü
Address
Ankara City Hospital, (Ankara Sehir Hastanesi), Üniversiteler Mahallesi Bilkent St. No:1 06800 Çankaya/Ankara, Turkey
Country
Turkey
Secondary sponsor category [1] 302243 0
None
Name [1] 302243 0
Address [1] 302243 0
Country [1] 302243 0
Other collaborator category [1] 280622 0
Individual
Name [1] 280622 0
Fabian Labra-Sprohnle
Address [1] 280622 0
Paediatric Research Unit
Nelson Marlborough District Health Board
PO Box: 1144 Nelson 7040
Country [1] 280622 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303030 0
Erzincan University Medical Faculty Ethical Committee
Ethics committee address [1] 303030 0
Ethics committee country [1] 303030 0
Turkey
Date submitted for ethics approval [1] 303030 0
Approval date [1] 303030 0
08/03/2019
Ethics approval number [1] 303030 0
01/19

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92230 0
Dr Hakan Ögütlü
Address 92230 0
Ankara City Hospital (Ankara Sehir Hastanesi) Üniversiteler Mahallesi Bilkent St. No:1 06800 Çankaya, Ankara, Turkey.
Country 92230 0
Turkey
Phone 92230 0
+905068509630
Fax 92230 0
Email 92230 0
[email protected]
Contact person for public queries
Name 92231 0
Fabian Labra-Sprohnle
Address 92231 0
Paediatric Research Unit
Nelson Marlborough District Health Board
PO Box: 1144 Nelson 7040
Country 92231 0
New Zealand
Phone 92231 0
+6435447866
Fax 92231 0
Email 92231 0
[email protected]
Contact person for scientific queries
Name 92232 0
Hakan Ögütlü
Address 92232 0
Ankara City Hospital (Ankara Sehir Hastanesi) Üniversiteler Mahallesi Bilkent St. No:1 06800 Çankaya, Ankara, Turkey.
Country 92232 0
Turkey
Phone 92232 0
+905068509630
Fax 92232 0
Email 92232 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.