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Trial registered on ANZCTR


Registration number
ACTRN12618001972213
Ethics application status
Approved
Date submitted
30/11/2018
Date registered
6/12/2018
Date last updated
4/12/2019
Date data sharing statement initially provided
6/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Attention deficit hyperactivity disorder, developmental coordination disorder, and the cognitive orientation to daily occupational performance approach: Is there a role for diagnostic profiling and treatment to improve mental health outcomes?
Scientific title
Attention deficit hyperactivity disorder, developmental coordination disorder, and the cognitive orientation to daily occupational performance approach: Is there a role for diagnostic profiling and treatment to improve mental health outcomes?
Secondary ID [1] 296751 0
Nil known.
Universal Trial Number (UTN)
U1111-1224-7914
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attention Deficit Hyperactivity Disorder 310631 0
Developmental Coordination Disorder 310632 0
Condition category
Condition code
Mental Health 309351 309351 0 0
Other mental health disorders
Physical Medicine / Rehabilitation 309352 309352 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project consists of two linked studies Study A; Diagnostic profiling for developmental coordination disorder in 8-12 year old children with attention deficit hyperactivity disorder, and Study B; Developmental coordination disorder, attention deficit hyperactivity disorder and the cognitive orientation to daily occupational performance approach: Is there a role for improving mental health outcomes?
Materials Used: pencils, pens, paper, assessment booklets (BOT-2 - readily available), informational/educational handouts re: DCD (from CanChild website - readily available), testing equipment (BOT-2 - readily available), intervention equipment pertaining directly to client chosen goal.
Procedures Used: Study A consists of a clinical interview and x2 assessments being conducted. Study B consists of an established intervention, the Cognitive Orientation to daily Occupational Performance (CO-OP) Approach being applied. CO-OP is a strategy-based problem-solving method of teaching and improving functional motor skills in 7-12 year olds. It typically runs over a 10 week period, although this can be slightly shorter or longer if required.
Intervention Delivery: Leiemma Canty, Occupational Therapist with 24 years clinical experience and is the postgraduate student researcher.
Mode of Delivery: face to face one-to-one sessions and phone calls.
Intervention Dosage: Study A will require a maximum of 2 hours per participant, with two face to face sessions to i) discuss project and ii) complete screening assessments and brief phone contact before and after sessions. Study B will involve a maximum of a 25 hour time commitment per participant, spread across a 24-28 week period, with participants seen up to 15 times, for 30-60 minute sessions. Sessions in Study B will be held in week 1, then weeks 5-17/20, then x1/mth for a further 2 months. A subset of participants from Study A will be invited to participate in Study B ie. if they are diagnosed with DCD, up to the first 10 to accept will participate in Study B.
Location: private practice clinic of postgraduate researcher, Invermay Allied Health.
Fidelity: the CO-OP Approach fidelity checklist will be completed by the postgraduate investigator for each participant at each face-to-face intervention session in Study B.
Intervention code [1] 313064 0
Diagnosis / Prognosis
Intervention code [2] 313065 0
Treatment: Other
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 308309 0
Developmental Coordination Disorder as assessed by the Developmental Coordination Disorder Questionnaire 2007 (DCDQ'07).
Timepoint [1] 308309 0
Data is collected during a 1.5 hour assessment session in Study A.
Primary outcome [2] 308327 0
Developmental Coordination Disorder as assessed by the Bruininks-Oseretsky Test of Motor Proficiency 2nd Ed. (BOT-2)

Adverse Events: may include mild physical discomfort and frustration with some of the assessment tasks.
Timepoint [2] 308327 0
Data is collected during a 1.5 hour assessment session in Study A.
Primary outcome [3] 308328 0
Performance and satisfaction ratings as assessed by the Canadian Occupational Performance Measure (COPM).
Timepoint [3] 308328 0
Reapeated measure in Study B - week 1 (face-to-face), week 2-4 (phone), week 5-15 (bi-weekly, x1 face-to-face and x1 phone), week 24 and 28 (by phone)..
Secondary outcome [1] 354593 0
Time use and participation patterns as assessed by the Children's Assessment of Participation and Enjoyment (CAPE) and the Preferences for Activities of Children (PAC)
Timepoint [1] 354593 0
Data will be collected pre-post in Study B (first and last face-to-face session).
Secondary outcome [2] 354618 0
Child mental health symptoms as assessed by the Revised Children's Anxiety and Depression Scale (RCADS), the NICHQ Vanderbilt Assessment Scales and the Brief Scales of Feelings and Emotions
Timepoint [2] 354618 0
Data will be collected pre-post in Study B (first and last face-to-face session).

Eligibility
Key inclusion criteria
Inclusion criteria:
- aged between 8-12 years
- must have a pre-existing diagnosis of ADHD
- current pharmacotherapy treatment for ADHD
- current Paediatrician
- if CO-OP is used in Study B with a participant also diagnosed with DCD in Study A, an additional inclusion criteria applies for cognition (have adequate cognitive ability to participate in the intervention program (the child can attend and understand the strategies to be used in the CO-OP Approach).
Minimum age
8 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
- clients without a pre-existing diagnosis of ADHD
- pre-exisiting motor disorder (as precludes a potential diagnosis of DCD)
- identified intellectual disability
- clients with ADHD currently unmedicated
- clients outside of Northern Tasmania
- cannot proceed to Study B if criteria for DCD not met in Study A.

Study design
Purpose of the study
Treatment
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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Single group
Other design features
Study B is a single subject experimental design.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size: 30 participants for Study A has been selected so as sufficient distribution is achieved to approximate a normal distribution of characteristics. As the aim and research question of Study A are not analytic, with descriptive statistics only being provided, no formalised power and effect size calculations were necessary to be conducted. Participants identified with the ADHD-DCD comorbidity from Study A will then be invited to participate in Study B and will form a subset sample N=10 (maximum).
Data analysis: de-identified raw data will be presented as descriptive statistics in Study A and will also be used to determine both clinical and statistical significance in Study B. Visual and statistical analysis will be used for the SSED in Study B.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/12/2018
Actual
10/12/2018
Date of last participant enrolment
Anticipated
4/02/2019
Actual
10/05/2019
Date of last data collection
Anticipated
31/08/2019
Actual
16/11/2019
Sample size
Target
30
Accrual to date
Final
19
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment postcode(s) [1] 25031 0
7248 - Invermay

Funding & Sponsors
Funding source category [1] 301331 0
Self funded/Unfunded
Name [1] 301331 0
Leiemma Canty, Occupational Therapist
Country [1] 301331 0
Australia
Funding source category [2] 301353 0
University
Name [2] 301353 0
La Trobe University
Country [2] 301353 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
La Trobe University
Plenty Rd & Kingsbury Drive
Bundoora
Victoria, Australia 3086
Country
Australia
Secondary sponsor category [1] 300997 0
None
Name [1] 300997 0
Address [1] 300997 0
Country [1] 300997 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302071 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 302071 0
Ethics committee country [1] 302071 0
Australia
Date submitted for ethics approval [1] 302071 0
Approval date [1] 302071 0
26/07/2018
Ethics approval number [1] 302071 0
HEC18239

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

Contacts
Principal investigator
Name 89022 0
Prof Leeanne Carey
Address 89022 0
La Trobe University
Plenty Rd & Kingsbury Drive
Bundoora
Victoria, Australia 3086
Country 89022 0
Australia
Phone 89022 0
+61 94795600
Fax 89022 0
Email 89022 0
L.Carey@latrobe.edu.au
Contact person for public queries
Name 89023 0
Leiemma Canty
Address 89023 0
La Trobe University
Plenty Rd & Kingsbury Drive
Bundoora
Victoria, Australia 3086
Country 89023 0
Australia
Phone 89023 0
+61478613593
Fax 89023 0
Email 89023 0
L.Canty@latrobe.edu.au
Contact person for scientific queries
Name 89024 0
Leiemma Canty
Address 89024 0
La Trobe University
Plenty Rd & Kingsbury Drive
Bundoora
Victoria, Australia 3086
Country 89024 0
Australia
Phone 89024 0
+61478613593
Fax 89024 0
Email 89024 0
L.Canty@latrobe.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
1. An identifiable summary of assessment results from Study A.
2. Personal results summary of participants.
3. De-identified data and data analysis for publications.

All other data is subject to the attached Research Data Management Plan.
When will data be available (start and end dates)?
1. Start: February 2019 & End: April 2019.
2. Start: February 2019 & End: August 2019
3. Start: February 2019 & End: December 2019
Available to whom?
1. Both private and public Paediatrician's will be involved in the diagnostic process of the research project.
2. To participants.
3. Wider audience and participants if they wish via publications.
Available for what types of analyses?
1. To aid with the DCD diagnostic decision making process at the end of Study A, to enable access into Study B.
2. & 3. For participants and the wider audience.
How or where can data be obtained?
1. Mailed or emailed.
2. Electronic or written form.
3. Publications such as thesis, journal article or conference presentations.


What supporting documents are/will be available?




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.