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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
Anxiety symptoms 334242 0
Depressive symptoms 334243 0
Condition category
Condition code
Anaesthesiology 330785 330785 0 0
Pain management
Mental Health 330786 330786 0 0
Anxiety
Mental Health 330787 330787 0 0
Depression

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] 328830 0
Behaviour
Intervention code [2] 328929 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338545 0
Disability (pain-related interference with daily living)
Timepoint [1] 338545 0
Pre-treatment (week 0), Mid-treatment (week 5), Post-treatment (week 9 - primary timepoint), Follow-up (week 26)
Primary outcome [2] 338546 0
Anxiety symptoms
Timepoint [2] 338546 0
Pre-treatment (week 0), Post-treatment (week 9 - primary timepoint), Follow-up (week 26)
Primary outcome [3] 338547 0
Depression symptoms
Timepoint [3] 338547 0
Pre-treatment (week 0), Post-treatment (week 9 - primary timepoint), Follow-up (week 26)
Secondary outcome [1] 436396 0
Physical functioning
Timepoint [1] 436396 0
Pre-treatment (week 0), Post-treatment (week 9), Follow-up (week 26)
Secondary outcome [2] 436397 0
Pain affect
Timepoint [2] 436397 0
Pre-treatment (week 0), Post-treatment (week 9)
Secondary outcome [3] 436398 0
Pain experience
Timepoint [3] 436398 0
Pre-treatment (week 0), Mid-treatment (week 5), Post-treatment (week 9), Follow-up (week 26)
Secondary outcome [4] 436399 0
Cognitive functioning
Timepoint [4] 436399 0
Pre-treatment (week 0), Post-treatment (week 9), Follow-up (week 26)
Secondary outcome [5] 436400 0
Quality of life
Timepoint [5] 436400 0
Pre-treatment (week 0), Post-treatment (week 9), Follow-up (week 26)
Secondary outcome [6] 436401 0
Parental emotional wellbeing - anxiety
Timepoint [6] 436401 0
Pre-treatment (week 0), Post-treatment (week 9), Follow-up (week 26)
Secondary outcome [7] 436402 0
Family functioning
Timepoint [7] 436402 0
Pre-treatment (week 0), Post-treatment (week 9), Follow-up (week 26)
Secondary outcome [8] 436403 0
Parental responding to pain
Timepoint [8] 436403 0
Pre-treatment (week 0), Post-treatment (week 9), Follow-up (week 26)
Secondary outcome [9] 436405 0
Adverse events
Timepoint [9] 436405 0
Post-treatment (week 9), Follow-up (week 26)
Secondary outcome [10] 436406 0
Global impression of change
Timepoint [10] 436406 0
Post-treatment (week 9)
Secondary outcome [11] 436407 0
Health economic outcome: Work/School absenteeism
Timepoint [11] 436407 0
Pre-treatment (week 0), Follow-up (week 26)
Secondary outcome [12] 436949 0
Health economic outcome: Health Services use
Timepoint [12] 436949 0
Pre-treatment (week 0), Follow-up (week 26)
Secondary outcome [13] 436950 0
Pain cognition
Timepoint [13] 436950 0
Pre-treatment (week 0), Post-treatment (week 9)
Secondary outcome [14] 436951 0
Treatment feasibility/acceptability: Treatment satisfaction
Timepoint [14] 436951 0
Post-Treatment (week 9)
Secondary outcome [15] 436952 0
Treatment feasibility/acceptability: Barriers to treatment
Timepoint [15] 436952 0
Post-treatment (week 9)
Secondary outcome [16] 437212 0
Parent emotional wellbeing - depression
Timepoint [16] 437212 0
Pre-treatment (week 0), Post-treatment (week 9), Follow-up (week 26)

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
Address
Country
Australia
Secondary sponsor category [1] 318953 0
None
Name [1] 318953 0
Address [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
https://www.mq.edu.au/research/ethics-integrity-and-policies/ethics/human-ethics
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
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.
Trial website
Trial related presentations / publications
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
Fax 134946 0
Email 134946 0
[email protected]
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
Fax 134947 0
Email 134947 0
[email protected]
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
Fax 134948 0
Email 134948 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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.
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.
Available to whom?
Researchers working with the approval, and under the governance, of a Human Research Ethics Committee following a data-sharing agreement.
Available for what types of analyses?
Any analyses required to verify the outcomes reported in published reports.
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.


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.