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Trial registered on ANZCTR


Registration number
ACTRN12615000296538
Ethics application status
Approved
Date submitted
29/01/2015
Date registered
31/03/2015
Date last updated
11/02/2020
Date data sharing statement initially provided
11/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Identifying Patterns of Executive Functions in children and adolescents with suspected Attention-Deficit-Hyperactive-Disorder using a novel computerized system: the EfA system
Scientific title
In children and adolescents, is assessment of ADHD using the novel "EfA system" as effective and sensitive as other known methods in reaching a high quality and accurate diagnosis?
Secondary ID [1] 285933 0
Nil
Universal Trial Number (UTN)
U1111-1165-6096
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attention Deficit Hyperactive Disorder (ADHD) 293861 0
Condition category
Condition code
Mental Health 294164 294164 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The research is comprised of two steps:
In step one: Once a client has enrolled to the study, he/she will be going through three independent assessments (which might take place over 1-3 weeks, depending on the client's and the clinic's schedules):
1. A clinical assessment is done by a consultant, either a Paediatrician or a Child Psychiatrist (up to 45 minutes)
2. A full TEA-Ch assessment (which is a pen and paper psychological assessment tool, done by a qualified psychologist, trained in administering the TEA-Ch)- up to 1.5 hours
3. A full EfA assessment: the EfA System is computer software which assesses functions of the brain related to ADHD. It is relatively short (duration of 25-35 min) assessment, comprised of 7 mini-games.

In step two: We will continue to use the same recruitment resources and research framework, only this time we will focus on the controls (non-ADHD) to gather a broader database of their measures, to establish a range of norms. This step will be initiated once we have collected 70-100 clients of the clinical sample (i.e. suspected to be diagnosed with ADHD).
Intervention code [1] 290910 0
Diagnosis / Prognosis
Comparator / control treatment
As for Step-1 of the research:
The control for this research will be a double-active one.
The Software (i.e. The EfA System) will be compared to both the TEA-Ch (=a validated psychological assessment tool) and to a clinical review done by a physician (as required by the current up-to-date literature and guidelines).

As for Step-2 of the research: there will be no control, as we are establishing norms only
Control group
Active

Outcomes
Primary outcome [1] 293954 0
Sensitivity of the EfA system will be calculated by statistical formula. See detailed formula in this link: http://ceaccp.oxfordjournals.org/content/8/6/221.full
Timepoint [1] 293954 0
One year after the research has been initiated
Primary outcome [2] 293955 0
Specificity of the EfA system will be calculated by statistical formula. See detailed formula in this link: http://ceaccp.oxfordjournals.org/content/8/6/221.full
Timepoint [2] 293955 0
One year after the research has been initiated
Primary outcome [3] 293956 0
Efficacy of the EfA system in comparison to the other diagnostic methods in the research. Efficacy is the capacity for beneficial change of a given intervention. We will compare resources invested, time consumption and overall sensitivity and specificity of each one of the 3 assessments. The assessment that would yield the best sensitivity/specificity, with the least amount of resource consumption, would be considered to have the highest efficacy.
Timepoint [3] 293956 0
One year after the research has been initiated
Secondary outcome [1] 312230 0
Assessment of the cost and burden in terms of time, money and human resources, of the three different methods of assessments: clinician, psychology and the software.
We will quantify each and every assessment in terms of time and money spent on completion, mounting to a total and average amount of resources for each and every test. Those figures will then be compared to each other.
Timepoint [1] 312230 0
One year after the research has been initiated

Eligibility
Key inclusion criteria
* Age 6-18 years
* Referred query ADHD
* Both the client and his/her parent/legal guardian have given their consent (when applicable)
* Both the client and the legal guardian are cognitively able to give an informed consent
Minimum age
6 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Known intellectual impairment
* Known major neurological disorder (such as: Epilepsy, CNS disease, head trauma, CP, etc)
* Sensory impairment (deafness, blindness)
* Other major mental health diagnosis (Psychosis, Major depression, Severe anxiety/OCD, etc)

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)
* The participants will be chosen from both CAMHS and Paediatric community clinics, ages 6-18 years and who were referred to either of the clinics query ADHD.
* The research is designed to be a national one, hence the CAMHS and Paediatric clinics will be chosen from various DHBs across New Zealand, who will choose to participate in the research. We will initially start in the Taranaki region in order to make sure that the software and database/servers are running smoothly. Then we will gradually incorporate more and more DHBs.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The trial is a non-randomized one
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
The trial is meant to become a national one, incorporating several DHBs across NZ. The initial phase will take place in Taranaki's DHB.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We will be using several comparative tests and tools in order to assess both the macro-level (i.e. the actual diagnosis) and the micro-level (i.e. comparison of sub-tests). Calculating the size of the sample needed for our study requires the prespecification of statistical power and the level of significance of the statistical test . The level of significance is the probability of obtaining a statistically significant test result, even when there is no real difference. This is conventionally taken as 2.5% for one-tailed tests.
Unfortunately - I cannot provide any exact or more detailed formula at the moment, as we are required to have several active participants so we can test our figures and statistical system. Once that will be done (after ethical approval has been granted) we could proceed and calculate a more precise number of clients/participants needed for our trial.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2015
Actual
1/04/2015
Date of last participant enrolment
Anticipated
30/12/2020
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
110
Final
Recruitment outside Australia
Country [1] 6619 0
New Zealand
State/province [1] 6619 0
Taranaki

Funding & Sponsors
Funding source category [1] 290654 0
Hospital
Name [1] 290654 0
"Taranaki Medical Foundation" which is based on the Taranaki District Heath Board's Base hospital (New Plymouth)
Country [1] 290654 0
New Zealand
Primary sponsor type
Individual
Name
Dr. Yariv Doron
Address
3 Bushview Place
Upper Vogeltown
New Plymouth 4310

Work organization (Main Sponsor):
Taranaki DHB
Base Hospital
23 David Street
Westown
New Plymouth 4310
Country
New Zealand
Secondary sponsor category [1] 289346 0
None
Name [1] 289346 0
Address [1] 289346 0
Country [1] 289346 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292284 0
Health and Disability Ethics Committee
Ethics committee address [1] 292284 0
Ethics committee country [1] 292284 0
New Zealand
Date submitted for ethics approval [1] 292284 0
30/01/2015
Approval date [1] 292284 0
26/02/2015
Ethics approval number [1] 292284 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 289 289 0 0
/AnzctrAttachments/367707-Research proposal 06.pdf

Contacts
Principal investigator
Name 53886 0
Dr Yariv Doron
Address 53886 0
Taranaki Base Hospital
Child and Adolescent Mental Health Services
David Street
New Plymouth 4620
Country 53886 0
New Zealand
Phone 53886 0
+6467537790
Fax 53886 0
Email 53886 0
yariv.doron@tdhb.org.nz
Contact person for public queries
Name 53887 0
Yariv Doron
Address 53887 0
Taranaki Base Hospital
Child and Adolescent Mental Health Services
David Street
New Plymouth 4620
Country 53887 0
New Zealand
Phone 53887 0
+6467537790
Fax 53887 0
Email 53887 0
yariv.doron@tdhb.org.nz
Contact person for scientific queries
Name 53888 0
Yariv Doron
Address 53888 0
Taranaki Base Hospital
Child and Adolescent Mental Health Services
David Street
New Plymouth 4620
Country 53888 0
New Zealand
Phone 53888 0
+6467537790
Fax 53888 0
Email 53888 0
yariv.doron@tdhb.org.nz

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.