Trial Review

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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
Scientific title
The Youth Pain Course: A feasibility trial of an Internet-delivered psychological pain management program for adolescents with chronic pain
Secondary ID [1] 312344 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic pain 334114 0
Depressive symptoms 334243 0
Anxiety symptoms 334242 0
Condition category
Condition code
Mental Health 330786 330786 0 0
Anxiety
Mental Health 330787 330787 0 0
Depression
Anaesthesiology 330785 330785 0 0
Pain management

Intervention/exposure
Study type
Interventional
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)
Intervention code [1] 328929 0
Treatment: Other
Intervention code [2] 328830 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338546 0
Anxiety symptoms
Assessment method [1] 338546 0
Revised Child Anxiety and Depression Scale (RCADS)
Timepoint [1] 338546 0
Pre-treatment (week 0), Post-treatment (week 9 - primary timepoint), Follow-up (week 26)
Primary outcome [2] 338547 0
Depression symptoms
Assessment method [2] 338547 0
Revised Child Anxiety and Depression Scale (RCADS)
Timepoint [2] 338547 0
Pre-treatment (week 0), Post-treatment (week 9 - primary timepoint), Follow-up (week 26)
Primary outcome [3] 338545 0
Disability (pain-related interference with daily living)
Assessment method [3] 338545 0
Child Activity Limitation Interview 9-item (CALI-9)
Timepoint [3] 338545 0
Pre-treatment (week 0), Mid-treatment (week 5), Post-treatment (week 9 - primary timepoint), Follow-up (week 26)
Secondary outcome [1] 436406 0
Global impression of change
Assessment method [1] 436406 0
Patient Global Impression of Change (PIC)
Timepoint [1] 436406 0
Post-treatment (week 9)
Secondary outcome [2] 436398 0
Pain experience
Assessment method [2] 436398 0
Custom-built questionnaire which includes questions on pain location, frequency, intensity, duration
Timepoint [2] 436398 0
Pre-treatment (week 0), Mid-treatment (week 5), Post-treatment (week 9), Follow-up (week 26)
Secondary outcome [3] 436397 0
Pain affect
Assessment method [3] 436397 0
Fear of Pain Questionnaire (FPQ)
Timepoint [3] 436397 0
Pre-treatment (week 0), Post-treatment (week 9)
Secondary outcome [4] 437212 0
Parent emotional wellbeing - depression
Assessment method [4] 437212 0
Patient Health Questionnaire 2-Item (PHQ-2)
Timepoint [4] 437212 0
Pre-treatment (week 0), Post-treatment (week 9), Follow-up (week 26)
Secondary outcome [5] 436399 0
Cognitive functioning
Assessment method [5] 436399 0
Patient-Reported Outcomes Measurement InformationSystem (PROMIS) – Cognitive functioning
Timepoint [5] 436399 0
Pre-treatment (week 0), Post-treatment (week 9), Follow-up (week 26)
Secondary outcome [6] 436402 0
Family functioning
Assessment method [6] 436402 0
Family Assessment Device (FAD) – General Functioning Scale
Timepoint [6] 436402 0
Pre-treatment (week 0), Post-treatment (week 9), Follow-up (week 26)
Secondary outcome [7] 436951 0
Treatment feasibility/acceptability: Treatment satisfaction
Assessment method [7] 436951 0
Treatment Satisfaction Questionnaire (TSQ)
Timepoint [7] 436951 0
Post-Treatment (week 9)
Secondary outcome [8] 436403 0
Parental responding to pain
Assessment method [8] 436403 0
Adult Responses to Children’s Symptoms (ARCS)
Timepoint [8] 436403 0
Pre-treatment (week 0), Post-treatment (week 9), Follow-up (week 26)
Secondary outcome [9] 436401 0
Parental emotional wellbeing - anxiety
Assessment method [9] 436401 0
Generalized Anxiety Disorder 2-Item (GAD-2)
Timepoint [9] 436401 0
Pre-treatment (week 0), Post-treatment (week 9), Follow-up (week 26)
Secondary outcome [10] 436407 0
Health economic outcome: Work/School absenteeism
Assessment method [10] 436407 0
Purpose-built questionnaire assessing youth and parental school/work absenteeism over the past 3 months.
Timepoint [10] 436407 0
Pre-treatment (week 0), Follow-up (week 26)
Secondary outcome [11] 436396 0
Physical functioning
Assessment method [11] 436396 0
Bath Adolescent Pain Questionnaire (BAPQ) – Physical Functioning Scale
Timepoint [11] 436396 0
Pre-treatment (week 0), Post-treatment (week 9), Follow-up (week 26)
Secondary outcome [12] 436952 0
Treatment feasibility/acceptability: Barriers to treatment
Assessment method [12] 436952 0
Barriers to Treatment Questionnaire (BTQ)
Timepoint [12] 436952 0
Post-treatment (week 9)
Secondary outcome [13] 436949 0
Health economic outcome: Health Services use
Assessment method [13] 436949 0
Purpose-built questionnaire assessing youth pain-health services use over the past 3 months.
Timepoint [13] 436949 0
Pre-treatment (week 0), Follow-up (week 26)
Secondary outcome [14] 436405 0
Adverse events
Assessment method [14] 436405 0
Purpose-built questionnaire assessing negative changes in disability, mood, stress and pain-interference during the trial.
Timepoint [14] 436405 0
Post-treatment (week 9), Follow-up (week 26)
Secondary outcome [15] 436400 0
Quality of life
Assessment method [15] 436400 0
Child Health Utility 9 Dimension (CHU9D)
Timepoint [15] 436400 0
Pre-treatment (week 0), Post-treatment (week 9), Follow-up (week 26)
Secondary outcome [16] 436950 0
Pain cognition
Assessment method [16] 436950 0
Pain Catastrophising Scale (PCS)
Timepoint [16] 436950 0
Pre-treatment (week 0), Post-treatment (week 9)

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.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2024
Actual
Date of last participant enrolment
Anticipated
29/08/2025
Actual
Date of last data collection
Anticipated
27/02/2026
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 316744 0
University
Name [1] 316744 0
Macquarie University
Country [1] 316744 0
Australia
Primary sponsor type
University
Name
Macquarie University
Country
Australia
Secondary sponsor category [1] 318953 0
None
Name [1] 318953 0
Country [1] 318953 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315515 0
Macquarie University Human Research Ethics Committee Medical Sciences
Ethics committee address [1] 315515 0
Ethics committee country [1] 315515 0
Australia
Date submitted for ethics approval [1] 315515 0
06/05/2024
Approval date [1] 315515 0
Ethics approval number [1] 315515 0

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 134946 0
Dr Joanne Dudeney
Address 134946 0
School of Psychological Sciences, 75 Talavera Rd, Macquarie University NSW 2109
Country 134946 0
Australia
Phone 134946 0
+612 9850 9464
Email 134946 0
joanne.dudeney@mq.edu.au
Contact person for public queries
Name 134947 0
Joanne Dudeney
Address 134947 0
School of Psychological Sciences, 75 Talavera Rd, Macquarie University NSW 2109
Country 134947 0
Australia
Phone 134947 0
+612 9850 9464
Email 134947 0
joanne.dudeney@mq.edu.au
Contact person for scientific queries
Name 134948 0
Joanne Dudeney
Address 134948 0
School of Psychological Sciences, 75 Talavera Rd, Macquarie University NSW 2109
Country 134948 0
Australia
Phone 134948 0
+612 9850 9464
Email 134948 0
joanne.dudeney@mq.edu.au

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers working with the approval, and under the governance, of a Human Research Ethics Committee following a data-sharing agreement.

Conditions for requesting access:
• -

What individual participant data might be shared?
• Any non-identifable data necessary to verify the outcomes reported in any published reports by the research team.

What types of analyses could be done with individual participant data?
• Any analyses required to verify the outcomes reported in published reports.

When can requests for individual participant data be made (start and end dates)?
From:
Data will be made available following publication of original reports from the trial. There will be no end date to the availability.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Data will be made available following formal request via email to the chief investigator (joanne.dudeney@mq.edu.au) 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.

Are there extra considerations when requesting access to individual participant data?
No


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.