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Trial registered on ANZCTR
Registration number
ACTRN12624000837527p
Ethics application status
Submitted, not yet approved
Date submitted
14/06/2024
Date registered
5/07/2024
Date last updated
5/07/2024
Date data sharing statement initially provided
5/07/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
The Youth Pain Course: A feasibility trial of an Internet-delivered psychological pain management program for adolescents with chronic pain
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Scientific title
The Youth Pain Course: A feasibility trial of an Internet-delivered psychological pain management program for adolescents with chronic pain
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Secondary ID [1]
312344
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic pain
334114
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Anxiety symptoms
334242
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Depressive symptoms
334243
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Condition category
Condition code
Anaesthesiology
330785
330785
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0
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Pain management
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Mental Health
330786
330786
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0
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Anxiety
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Mental Health
330787
330787
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0
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Depression
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The Youth Pain Course is an Internet-delivered psychological pain management program.
Youth component
The course contains 6 child modules, delivered over 8 weeks.
The modules provide adolescents with information and skills for the management of chronic pain generally as well as the comorbid pain-related disability, anxiety and depression that often result. Module content is structured around four themes, common in Cognitive Behaviour Therapy (CBT)-based psychological pain management interventions: (1) Education, (2) Behavioural skills, (3) Cognitive strategies, and (4) Relapse prevention.
Modules are delivered online and a mix of static information, audio and videos, they are released every week or other-week over the 8-weeks, and should take participants 20-30minutes to work through.
Lessons will be accompanied by an activity adolescents will work through during the week, and detailed examples of adolescents with different chronic pain conditions to illustrate how to integrate the skills learnt into every-day life.
Parent/guardian component
Parents/guardians have access to the youth course materials from their own login and will also be provided with their own online materials to support their child. For example, education and skills in adaptive communication, responding to pain, reinforcing adolescent activity despite pain, supporting autonomy, and modelling behaviour. This content will be delivered via 3-4 modules, released over the first 5 weeks of the course (weekly or fortnightly).
Clinician contact
Each week, youth and parents/guardians will have brief contact with a trial clinician (approximately 15 minutes per participant), who will support the family’s progress through the course via phone calls or through a private messaging system, per participant preference. Trial clinicians will be nationally registered psychologists.
Adherence
Adherence to the course will be monitored via the number of logins to the platform, % of modules accessed, and volume of contact with the clinician.
Questionnaires
All participants will be asked to complete questionnaire at the following timepoints:
- Pre-treatment (20 minutes)
- Midway through treatment (week 5; 5 minutes)
- Post-treatment (15 minutes)
- 6 months follow-up (15 minutes)
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Intervention code [1]
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Behaviour
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Intervention code [2]
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Treatment: Other
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Disability (pain-related interference with daily living)
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Assessment method [1]
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Child Activity Limitation Interview 9-item (CALI-9)
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Timepoint [1]
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Pre-treatment (week 0), Mid-treatment (week 5), Post-treatment (week 9 - primary timepoint), Follow-up (week 26)
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Primary outcome [2]
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Anxiety symptoms
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Assessment method [2]
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Revised Child Anxiety and Depression Scale (RCADS)
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Timepoint [2]
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Pre-treatment (week 0), Post-treatment (week 9 - primary timepoint), Follow-up (week 26)
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Primary outcome [3]
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Depression symptoms
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Assessment method [3]
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Revised Child Anxiety and Depression Scale (RCADS)
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Timepoint [3]
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Pre-treatment (week 0), Post-treatment (week 9 - primary timepoint), Follow-up (week 26)
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Secondary outcome [1]
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Physical functioning
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Assessment method [1]
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Bath Adolescent Pain Questionnaire (BAPQ) – Physical Functioning Scale
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Timepoint [1]
436396
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Pre-treatment (week 0), Post-treatment (week 9), Follow-up (week 26)
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Secondary outcome [2]
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Pain affect
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Assessment method [2]
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Fear of Pain Questionnaire (FPQ)
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Timepoint [2]
436397
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Pre-treatment (week 0), Post-treatment (week 9)
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Secondary outcome [3]
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Pain experience
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Assessment method [3]
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Custom-built questionnaire which includes questions on pain location, frequency, intensity, duration
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Timepoint [3]
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Pre-treatment (week 0), Mid-treatment (week 5), Post-treatment (week 9), Follow-up (week 26)
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Secondary outcome [4]
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Cognitive functioning
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Assessment method [4]
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Patient-Reported Outcomes Measurement InformationSystem (PROMIS) – Cognitive functioning
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Timepoint [4]
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Pre-treatment (week 0), Post-treatment (week 9), Follow-up (week 26)
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Secondary outcome [5]
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Quality of life
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Assessment method [5]
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Child Health Utility 9 Dimension (CHU9D)
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Timepoint [5]
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Pre-treatment (week 0), Post-treatment (week 9), Follow-up (week 26)
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Secondary outcome [6]
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Parental emotional wellbeing - anxiety
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Assessment method [6]
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Generalized Anxiety Disorder 2-Item (GAD-2)
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Timepoint [6]
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Pre-treatment (week 0), Post-treatment (week 9), Follow-up (week 26)
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Secondary outcome [7]
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Family functioning
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Assessment method [7]
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Family Assessment Device (FAD) – General Functioning Scale
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Timepoint [7]
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Pre-treatment (week 0), Post-treatment (week 9), Follow-up (week 26)
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Secondary outcome [8]
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Parental responding to pain
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Assessment method [8]
436403
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Adult Responses to Children’s Symptoms (ARCS)
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Timepoint [8]
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Pre-treatment (week 0), Post-treatment (week 9), Follow-up (week 26)
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Secondary outcome [9]
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Adverse events
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Assessment method [9]
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Purpose-built questionnaire assessing negative changes in disability, mood, stress and pain-interference during the trial.
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Timepoint [9]
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Post-treatment (week 9), Follow-up (week 26)
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Secondary outcome [10]
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Global impression of change
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Assessment method [10]
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Patient Global Impression of Change (PIC)
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Timepoint [10]
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Post-treatment (week 9)
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Secondary outcome [11]
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Health economic outcome: Work/School absenteeism
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Assessment method [11]
436407
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Purpose-built questionnaire assessing youth and parental school/work absenteeism over the past 3 months.
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Timepoint [11]
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Pre-treatment (week 0), Follow-up (week 26)
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Secondary outcome [12]
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Health economic outcome: Health Services use
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Assessment method [12]
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Purpose-built questionnaire assessing youth pain-health services use over the past 3 months.
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Timepoint [12]
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Pre-treatment (week 0), Follow-up (week 26)
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Secondary outcome [13]
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Pain cognition
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Assessment method [13]
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Pain Catastrophising Scale (PCS)
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Timepoint [13]
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Pre-treatment (week 0), Post-treatment (week 9)
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Secondary outcome [14]
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Treatment feasibility/acceptability: Treatment satisfaction
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Assessment method [14]
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Treatment Satisfaction Questionnaire (TSQ)
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Timepoint [14]
436951
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Post-Treatment (week 9)
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Secondary outcome [15]
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Treatment feasibility/acceptability: Barriers to treatment
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Assessment method [15]
436952
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Barriers to Treatment Questionnaire (BTQ)
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Timepoint [15]
436952
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Post-treatment (week 9)
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Secondary outcome [16]
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Parent emotional wellbeing - depression
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Assessment method [16]
437212
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Patient Health Questionnaire 2-Item (PHQ-2)
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Timepoint [16]
437212
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Pre-treatment (week 0), Post-treatment (week 9), Follow-up (week 26)
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Eligibility
Key inclusion criteria
a) Aged between 12-17
b) Presence of persistent or recurrent pain for three months or more.
c) Experiencing the impact of pain on at least one area of daily functioning.
d) Lives with a parent/guardian who is willing to take part in the trial.
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Minimum age
12
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Adolescent exclusion criteria are:
a) Imminently suicidal or unable to keep themselves safe.
b) Parent/guardian-reported child developmental disability which would impede participation.
c) Does not have access to the internet.
d) Unable to read and understand English.
Parent/guardian exclusion criteria are:
a) Imminently suicidal or unable to keep themselves safe.
b) Does not have access to the internet.
c) Unable to read and understand English.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/08/2024
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Actual
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Date of last participant enrolment
Anticipated
29/08/2025
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Actual
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Date of last data collection
Anticipated
27/02/2026
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Actual
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Sample size
Target
90
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Macquarie University
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
University
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Name
Macquarie University
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
318953
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Country [1]
318953
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
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Macquarie University Human Research Ethics Committee Medical Sciences
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Ethics committee address [1]
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https://www.mq.edu.au/research/ethics-integrity-and-policies/ethics/human-ethics
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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06/05/2024
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Approval date [1]
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Ethics approval number [1]
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Summary
Brief summary
The primary objective is to evaluate the feasibility of an Internet-delivered psychology pain self-management program, the Youth Pain Course (YPC), for Australian adolescents with chronic pain. This will be achieved through the following aims: 1. Assessing the acceptability of the YPC, via levels of treatment engagement, adherence, and adolescent- and carer-reported treatment satisfaction. 2. Determining the potential efficacy of the YPC on improving disability, pain severity and emotional functioning, post-treatment and at 6-months follow-up. 3. Exploring the demographic and clinical moderators (predictors) of treatment feasibility, including acceptability, efficacy, and costs. 4. Completing a preliminary cost-consequence analysis examining the costs of the treatment to providers, adolescents, and their carers, in relation to a range of potential economic outcomes.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Joanne Dudeney
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Address
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School of Psychological Sciences, 75 Talavera Rd, Macquarie University NSW 2109
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Country
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Australia
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Phone
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+612 9850 9464
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Joanne Dudeney
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Address
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School of Psychological Sciences, 75 Talavera Rd, Macquarie University NSW 2109
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Country
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Australia
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Phone
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+612 9850 9464
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Joanne Dudeney
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Address
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School of Psychological Sciences, 75 Talavera Rd, Macquarie University NSW 2109
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Country
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Australia
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Phone
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+612 9850 9464
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Any non-identifable data necessary to verify the outcomes reported in any published reports by the research team.
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When will data be available (start and end dates)?
Data will be made available following publication of original reports from the trial. There will be no end date to the availability.
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Available to whom?
Researchers working with the approval, and under the governance, of a Human Research Ethics Committee following a data-sharing agreement.
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Available for what types of analyses?
Any analyses required to verify the outcomes reported in published reports.
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How or where can data be obtained?
Data will be made available following formal request via email to the chief investigator (
[email protected]
) using a mechanism that is satisfactory for the Macquarie University Human Research Ethics Committee (providing governance for the current research) and any other Human Research Ethics Committee's involved.
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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.
Download to PDF