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Trial registered on ANZCTR


Registration number
ACTRN12618000387224
Ethics application status
Approved
Date submitted
5/03/2018
Date registered
15/03/2018
Date last updated
22/04/2020
Date data sharing statement initially provided
22/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Asking the right questions about attention-deficit hyperactivity disorder in children: evaluating the impact of a novel question prompt list
Scientific title
Asking the right questions about attention-deficit hyperactivity disorder in children: a cluster randomized controlled trial
Secondary ID [1] 294236 0
Nil Known
Universal Trial Number (UTN)
U1111-1205-8719
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attention-deficit hyperactivity disorder 306910 0
Condition category
Condition code
Mental Health 306003 306003 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A cluster randomised controlled trial will be used to evaluate the impact of a novel attention-deficit hyperactivity disorder (ADHD)-specific question prompt list (QPL).

The ADHD-specific QPL, the first to be developed, addresses pertinent issues across a child’s developmental lifespan. It consists of 88 structured questions on diagnosis, understanding ADHD, treatment (medicines, psychological, alternative), healthcare team, monitoring and managing ADHD, future expectations (approaching adolescence, health and medicines, academic and social progress), and support and information. The questions are written in simple language. The QPL is not intended to influence prescribing practice; it is intended to be used by parents to support question asking during consultations with clinicians over the lifespan of the child’s ADHD, i.e. into adolescence and adulthood if required.

The intervention group parents will be mailed a hardcopy of the ADHD-specific QPL to use at two consecutive visits to the paediatrician. The QPL will be given “extended paediatrician endorsement”. All intervention group paediatricians will be trained in “extended endorsement” of the QPL.

This novel attention-deficit hyperactivity disorder (ADHD)-specific question prompt list (QPL) was developed as a result of a qualitative needs analysis [1], Delphi study [2], and user testing [3], conducted by members of the research team.

1. Ahmed R, Borst JM, Yong CW, Aslani P (2014) Do parents of children with attention-deficit/hyperactivity disorder (ADHD) receive adequate information about the disorder and its treatments? A qualitative investigation Patient Preference and Adherence 8(8):661-670. doi: 10.2147/PPA.S60164
2. Ahmed R, McCaffery KJ, Aslani P (2016) Development and validation of a question prompt list for parents of children with attention-deficit/hyperactivity disorder: a Delphi study Health Expectations 19(2):234-252. doi: 10.1111/hex.12341
3. Ahmed R, Raynor DK, McCaffery KJ, Aslani P (2014) The design and user-testing of a question prompt list for attention-deficit/hyperactivity disorder BMJ Open 4(12):e006585. doi: 10.1136/bmjopen-2014-006585
Intervention code [1] 300530 0
Behaviour
Comparator / control treatment
A published information leaflet about ADHD (sourced from the KidsMatter website) will be mailed to control group parents to control for attention.
Control group
Active

Outcomes
Primary outcome [1] 305038 0
Adherence to therapy, assessed via the Medication Possession Ratio (MPR) and Proportion of Days Covered (PDC) measures, to be determined by accessing medication dispensing records.

This is a composite primary outcome.
Timepoint [1] 305038 0
Medication dispensing records obtained at 12 months after baseline for the nominated study period.
Primary outcome [2] 305039 0
Adherence to therapy, assessed via salivary sample analysis (for children using methylphenidate only).
Timepoint [2] 305039 0
Salivary samples taken at baseline/the first consultation, at the second consultation (primary timepoint), and at 12 months after baseline (at follow-up).
Primary outcome [3] 305098 0
Number of questions asked by parents and children, assessed via coding of the transcripts of each of the audio-recorded consultations.
Timepoint [3] 305098 0
Audio recordings of each consultation will be analysed by the researchers after each consultation.
Secondary outcome [1] 343969 0
Shared decision making, assessed via the use of the ‘observing patient involvement’ (OPTION) scale
Timepoint [1] 343969 0
Every consultation recorded during this study will be scored using the OPTION scale by the researchers after each consultation
Secondary outcome [2] 343970 0
Parent recall of clinicians’ recommendations, assessed via telephone interview.
Timepoint [2] 343970 0
Up to/approximately 7 days after the first consultation and up to/approximately 7 days after the second consultation.
Secondary outcome [3] 343971 0
Beliefs about medicines, elicited using the validated Beliefs about Medicines Questionnaire (BMQ-Specific), with the items adapted for the parent/caregiver to answer about their child’s ADHD medication.
Timepoint [3] 343971 0
At baseline, up to/approximately 7 days after the second consultation, and 12 months after baseline.
Secondary outcome [4] 343972 0
Achievement of information elicited by the Cassileth Information Styles Questionnaire .
Timepoint [4] 343972 0
At baseline, up to/approximately 7 days after the second consultation, and 12 months after baseline.
Secondary outcome [5] 343973 0
Decisional self-efficacy, measured using the Decision Self-Efficacy Scale.
Timepoint [5] 343973 0
At baseline, up to/approximately 7 days after the second consultation, and 12 months after baseline.
Secondary outcome [6] 343974 0
Depression, measured using Center for Epidemiologic Studies Depression Scale (CES-D).
Timepoint [6] 343974 0
At baseline, up to/approximately 7 days after the first consultation, up to/approximately 7 days after the second consultation, and 12 months after baseline.
Secondary outcome [7] 343975 0
Health-related quality of life, measured using the 50-item parent form version of the Child Health Questionnaire (CHQ-PF50).
Timepoint [7] 343975 0
At baseline, up to/approximately 7 days after the first consultation, up to/approximately 7 days after the second consultation, and 12 months after baseline.
Secondary outcome [8] 343976 0
Satisfaction with care/interaction, measured using questionnaire items developed by Street.

Citation: Street RL. Physicians’ communication and parents’ evaluations of pediatric consultations. Med Care 1991;29:1146–1152
Timepoint [8] 343976 0
Up to/approximately 7 days after the first consultation and up to/approximately 7 days after the second consultation.
Secondary outcome [9] 343977 0
Parent views about the acceptability and impact of the QPL/information leaflet, elicited using a 20-item questionnaire adapted from that used by Clayton et al. and any open-ended comments given about the QPL/information leaflet.

Citation: Clayton J, Butow P, Tattersall M, Chye R, Noel M, Davis JM, Glare P. Asking questions can help: development and preliminary evaluation of a question prompt list for palliative care patients. Brit J Cancer 2003;89:2069-77
Timepoint [9] 343977 0
Up to/approximately 7 days after the first consultation, up to/approximately 7 days after the second consultation, and 12 months after baseline.
Secondary outcome [10] 343978 0
Clinician satisfaction with the consultation and views about acceptability of the QPL/information leaflet, measured using study-developed Likert scales.
Timepoint [10] 343978 0
At the end of the first consultation and at the end of the second consultation. Furthermore, at the end of the study, clinicians will be asked to rate the usefulness of the QPL/information leaflet and comment on whether they would incorporate the QPL/information leaflet into their everyday practice.
Secondary outcome [11] 344329 0
Involvement preferences, elicited by adapted items from the Control Preferences Scale for Pediatrics.
Timepoint [11] 344329 0
At baseline, up to/approximately 7 days after the second consultation, and 12 months after baseline.

Eligibility
Key inclusion criteria
Key inclusion criteria for paediatricians (including child psychiatrists) are that they:
(i) are practising in private or public health settings; and
(ii) manage and treat children with ADHD.

Parents attending the practices of the enrolled paediatricians will be eligible to participate if they:
(i) are 18 years or older;
(ii) have a child (aged 3-18 years) with a recent diagnosis of ADHD (in the previous 12 months) irrespective of type of pharmacological or non-pharmacological treatment;
(iii) are the primary carer of their child; and
(iv) are fluent in the English language.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Parents are not eligible for inclusion if their child has a diagnosis of autism spectrum disorder (ASD) and ADHD, as the focus of parents’ questions will likely be on ASD rather than ADHD.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This study adopts a cluster randomised controlled trial design. Consenting paediatricians will be randomly allocated to control and intervention groups. Allocation will be concealed, and will involve contact with the biostatistician on the research team who will hold the block randomisation list. The biostatistician will not be directly involved in the recruitment process.

Parents/carers recruited from the clinics of consenting paediatricians will be assigned to the same group as their child’s paediatrician.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Consenting paediatricians will be randomised to either the intervention or control group via block randomisation, stratified by public/private practice.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/03/2018
Actual
29/03/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
390
Accrual to date
47
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 298876 0
Government body
Name [1] 298876 0
National Health and Medical Research Council
Country [1] 298876 0
Australia
Primary sponsor type
Individual
Name
Parisa Aslani
Address
The University of Sydney School of Pharmacy
Faculty of Medicine and Health
Pharmacy and Bank Building (A15)
Science Road
The University of Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 298085 0
None
Name [1] 298085 0
Address [1] 298085 0
Country [1] 298085 0
Other collaborator category [1] 279993 0
Individual
Name [1] 279993 0
Michael Kohn
Address [1] 279993 0
Westmead Hospital
Corner Hawkesbury Road and Darcy Road
Westmead NSW 2145
Country [1] 279993 0
Australia
Other collaborator category [2] 279994 0
Individual
Name [2] 279994 0
Natalie Silove
Address [2] 279994 0
The Children’s Hospital at Westmead
Corner Hawkesbury Road and Hainsworth Street
Westmead NSW 2145
Country [2] 279994 0
Australia
Other collaborator category [3] 279995 0
Individual
Name [3] 279995 0
Patrick Kelly
Address [3] 279995 0
The University of Sydney School of Public Health
Faculty of Medicine and Health
Edward Ford Building (A27)
University of Sydney NSW 2006
Country [3] 279995 0
Australia
Other collaborator category [4] 279996 0
Individual
Name [4] 279996 0
Simon Clarke
Address [4] 279996 0
Westmead Hospital
Corner Hawkesbury Road and Darcy Road
Westmead NSW 2145
Country [4] 279996 0
Australia
Other collaborator category [5] 279997 0
Individual
Name [5] 279997 0
Phyllis Butow
Address [5] 279997 0
Centre for Medical Psychology & Evidence-based Decision-making Chris O'Brien Lifehouse (C39Z)
University of Sydney NSW 2006
Country [5] 279997 0
Australia
Other collaborator category [6] 279998 0
Individual
Name [6] 279998 0
Kirsten McCaffery
Address [6] 279998 0
The University of Sydney School of Public Health
Faculty of Medicine and Health
Edward Ford Building (A27)
University of Sydney NSW 2006
Country [6] 279998 0
Australia
Other collaborator category [7] 279999 0
Individual
Name [7] 279999 0
Paul Groundwater
Address [7] 279999 0
The University of Sydney School of Pharmacy
Faculty of Medicine and Health
Pharmacy and Bank Building (A15)
Science Road
The University of Sydney
NSW 2006
Country [7] 279999 0
Australia
Other collaborator category [8] 280000 0
Individual
Name [8] 280000 0
Vivien Tong
Address [8] 280000 0
The University of Sydney School of Pharmacy
Faculty of Medicine and Health
Pharmacy and Bank Building (A15)
Science Road
The University of Sydney
NSW 2006
Country [8] 280000 0
Australia
Other collaborator category [9] 280001 0
Individual
Name [9] 280001 0
Rana Ahmed
Address [9] 280001 0
School of Health and Biomedical Sciences - RMIT University
Corner Janefield Drive and Plenty Road
Bundoora VIC 3083
Country [9] 280001 0
Australia
Other collaborator category [10] 281293 0
Individual
Name [10] 281293 0
Michelle Mui Sze
Address [10] 281293 0
The University of Sydney School of Pharmacy
Faculty of Medicine and Health
Pharmacy and Bank Building (A15)
Science Road
The University of Sydney
NSW 2006
Country [10] 281293 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299817 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 299817 0
Ethics committee country [1] 299817 0
Australia
Date submitted for ethics approval [1] 299817 0
03/07/2017
Approval date [1] 299817 0
03/10/2017
Ethics approval number [1] 299817 0
2017/584
Ethics committee name [2] 305845 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [2] 305845 0
Ethics committee country [2] 305845 0
Australia
Date submitted for ethics approval [2] 305845 0
15/11/2017
Approval date [2] 305845 0
30/05/2018
Ethics approval number [2] 305845 0
AU RED HREC/17/WMEAD/560

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

Contacts
Principal investigator
Name 81658 0
Prof Parisa Aslani
Address 81658 0
The University of Sydney School of Pharmacy
Faculty of Medicine and Health
Pharmacy and Bank Building (A15)
Science Road
The University of Sydney
NSW 2006
Country 81658 0
Australia
Phone 81658 0
+61 2 9036 6541
Fax 81658 0
+61 2 9351 4391
Email 81658 0
[email protected]
Contact person for public queries
Name 81659 0
Parisa Aslani
Address 81659 0
The University of Sydney School of Pharmacy
Faculty of Medicine and Health
Pharmacy and Bank Building (A15)
Science Road
The University of Sydney
NSW 2006
Country 81659 0
Australia
Phone 81659 0
+61 2 9036 6541
Fax 81659 0
+61 2 9351 4391
Email 81659 0
[email protected]
Contact person for scientific queries
Name 81660 0
Parisa Aslani
Address 81660 0
The University of Sydney School of Pharmacy
Faculty of Medicine and Health
Pharmacy and Bank Building (A15)
Science Road
The University of Sydney
NSW 2006
Country 81660 0
Australia
Phone 81660 0
+61 2 9036 6541
Fax 81660 0
+61 2 9351 4391
Email 81660 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.