Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001091897p
Ethics application status
Not yet submitted
Date submitted
29/06/2021
Date registered
18/08/2021
Date last updated
28/04/2024
Date data sharing statement initially provided
18/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The Youth Pain Course: An Internet-delivered psychological pain management program for adolescents with chronic pain
Scientific title
Examining the effectiveness of the Youth Pain Course: A randomised controlled trial of an Internet-delivered psychological pain management program for adolescents with chronic pain
Secondary ID [1] 303849 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic pain 321413 0
Anxiety 321414 0
Depression 321415 0
Condition category
Condition code
Anaesthesiology 319173 319173 0 0
Pain management
Mental Health 319174 319174 0 0
Anxiety
Mental Health 319175 319175 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Youth Pain Course comprises 6 modules, delivered via the Internet 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 CBT-based psychological pain management interventions: (1) Education, (2) Behavioural skills, (3) Cognitive strategies, and (4) Relapse prevention.

Each module will take approximately 20 minutes to complete. Content will be delivered onscreen via text, illustrations, video and audio and will involve a variety of examples. Modules will be accompanied by an activity (e.g., goal setting, activity pacing, thought challenging) participants will work through during the week, and detailed case examples of other adolescents with different chronic pain conditions. Participants will be asked to practice the activities at least three times a week, for around 30 minutes each time. Caregivers will also be provided with online materials to support their child.

Each week participants will have brief contact lasting around 10-15 minutes with a nationally registered psychologist, who will support the family’s progress through the course via phone calls or through a private messaging system. Psychologists supporting families through the course will receive training and supervision from senior clinical psychologists in the team to ensure competence and safety in their practice. Participants will also receive automated email and/or text message reminders prompting and reminding the practice of skills and progression through the course.

Study questionnaires will be administered to adolescents and caregivers at application, pre-treatment, mid-treatment, post-treatment, and at 3- and 12-month follow-up. The major sets of questionnaires will take about 20-minutes to complete.
Intervention code [1] 320153 0
Treatment: Other
Intervention code [2] 320154 0
Behaviour
Comparator / control treatment
The control group is a "standard care waitlist control". The control group receive access to the Youth Pain Course following the 8-week control period.
Control group
Active

Outcomes
Primary outcome [1] 327234 0
Disability; assessed via the Child Activity Limitation Interview 9-item [CALI-9].
Timepoint [1] 327234 0
Child & Caregiver report: Administered at application, pre-treatment, mid-treatment, post-treatment, 3-month follow-up and 12-month follow-up.
Primary outcome [2] 327235 0
Anxiety symptoms; assessed via the Revised Child Anxiety and Depression Scale [RCADS].
Timepoint [2] 327235 0
Child & Caregiver report: Administered at pre-treatment, post-treatment, 3-month follow-up and 12-month follow-up.
Primary outcome [3] 327236 0
Depression symptoms; assessed via the Revised Child Anxiety and Depression Scale [RCADS].
Timepoint [3] 327236 0
Child & Caregiver report: Administered at pre-treatment, post-treatment, 3-month follow-up and 12-month follow-up.
Secondary outcome [1] 394325 0
Pain experience; assessed via the PROMIS Pediatric Pain Intensity - Short form (pain intensity) and a purpose built measure to assess aspects of patients pain (frequency, duration, location).
Timepoint [1] 394325 0
Child report: Administered at application, pre-treatment, mid-treatment, post-treatment, 3-month follow-up and 12-month follow-up.
Secondary outcome [2] 397520 0
Pain affect and cognition; assessed via the Fear of Pain Questionnaire [FPQ; affect] and the Pain Catastrophising Scale [PCS; cognition] and Pain Vigilance and Awareness Questionnaire [PVAQ; cognition].
Timepoint [2] 397520 0
Child report: Administered at pre-treatment and post-treatment.

Caregiver report (PCS only): Administered at pre-treatment and post-treatment.
Secondary outcome [3] 397526 0
Quality of Life; assessed via the Child Health Utility Instrument - 9 dimension [CHU9D]
Timepoint [3] 397526 0
Child & Caregiver report: Administered at pre-treatment, post-treatment, 3-month follow-up and 12-month follow-up.
Secondary outcome [4] 397527 0
Presenteeism and Absenteeism; assessed via a purpose built measure.
Timepoint [4] 397527 0
Child report: Administered at pre-treatment, post-treatment, 3-month follow-up and 12-month follow-up.

Caregiver report: Administered at application, post-treatment, 3-month follow-up and 12-month follow-up.
Secondary outcome [5] 397528 0
Sleep; assessed via the Adolescent Insomnia Questionnaire [AIQ]
Timepoint [5] 397528 0
Child report: Administered at pre-treatment and post-treatment.
Secondary outcome [6] 397529 0
Cognitive functioning; assessed via the Behavior Rating Inventory of Executive Function 2 [BREIF-2] Screener.
Timepoint [6] 397529 0
Child & Caregiver report: Administered at pre-treatment, post-treatment, 3-month follow-up and 12-month follow-up.
Secondary outcome [7] 397530 0
Treatment Satisfaction; assessed via a purpose built measure.
Timepoint [7] 397530 0
Child & Caregiver report: Administered at post-treatment.
Secondary outcome [8] 397531 0
Barriers to treatment; assessed via a purpose built measure.
Timepoint [8] 397531 0
Child report: Administered at post-treatment.
Secondary outcome [9] 397532 0
Treatment expectancy; assessed via the Credibility and Expectancy Questionnaire [CEQ].
Timepoint [9] 397532 0
Child & Caregiver report: Administered at pre-treatment.
Secondary outcome [10] 397533 0
Family functioning; assessed via the Family Assessment Device [FAD] - general functioning scale.
Timepoint [10] 397533 0
Caregiver report: Administered at pre-treatment, post-treatment, 3-month follow-up and 12-month follow-up.
Secondary outcome [11] 397534 0
Caregiver pain responses; assessed via the Adult Responses to Children's Symptoms [ARCS].
Timepoint [11] 397534 0
Caregiver report: Administered at pre-treatment, post-treatment, 3-month follow-up and 12-month follow-up.
Secondary outcome [12] 397535 0
Caregiver mental health; assessed via the Generalised Anxiety Disorder - 2 [GAD-2; anxiety] and the Patient Health Questionnaire - 2 [PHQ-2; depression].
Timepoint [12] 397535 0
Caregiver report: administered at pre-treatment and post-treatment.
Secondary outcome [13] 397536 0
Caregiver disability; assessed via the World Health Organization Disability Assessment Schedule 2.0 12-Item [WHODAS-12]
Timepoint [13] 397536 0
Caregiver report: Administered at pre-treatment and post-treatment.

Eligibility
Key inclusion criteria
1) Aged between 12-17
2) Presence of persistent or recurrent pain for three months or more
3) Experiencing the impact of pain on at least one area of daily functioning
4) Lives with a parent (or primary caregiver), who is willing to take part in the trial
5) Willingness to provide informed consent and willingness to participate and comply with the study requirements.
Minimum age
12 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Adolescent exclusion criteria are:
1) Imminently suicidal or unable to keep themselves safe
2) Parent-reported child developmental disability which would impede participation
3) Currently receiving treatment for a serious medical condition (e.g., cancer, transplant)
4) Does not have access to a computer or the internet
5) Unable to read and understand English.

Caregiver exclusion criteria are:
1) Imminently suicidal or unable to keep themselves safe
2) Does not have access to a computer or the internet
3) Unable to read and understand English.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Concealment occurs through the use of locked and concealed cells in a spreadsheet, which recruitment staff are required to open serially.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will occur at application, prior to any contact with study staff. Participants will be randomised using a list generated prior to the study via a software program (www.random.org) using a stratified block randomisation process.
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
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Due to the novelty of this project for an Australian adolescent population the trial design has been amended to a single-group feasibility study. As such, we have withdrawn this project and will register a new trial with ANZCTN with the updated trial design information and measures.
Date of first participant enrolment
Anticipated
1/01/2022
Actual
Date of last participant enrolment
Anticipated
31/08/2023
Actual
Date of last data collection
Anticipated
30/11/2024
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 308244 0
University
Name [1] 308244 0
Macquarie University
Country [1] 308244 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
eCentreClinic
Department of Psychology, Faculty of Medicine, Health and Human Sciences
Balaclava Road, North Ryde NSW 2109
Country
Australia
Secondary sponsor category [1] 309037 0
None
Name [1] 309037 0
Address [1] 309037 0
Country [1] 309037 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 308224 0
Macquarie University Human Ethics Committee
Ethics committee address [1] 308224 0
Macquarie University
Balaclava Road, North Ryde NSW, 2109
Ethics committee country [1] 308224 0
Australia
Date submitted for ethics approval [1] 308224 0
30/09/2021
Approval date [1] 308224 0
Ethics approval number [1] 308224 0

Summary
Brief summary
The primary objective is to evaluate, through a randomised controlled trial, the clinical efficacy of an Internet-delivered pain self-management program, the Youth Pain Course, for adolescents with chronic pain. Clinical efficacy will be assessed through clinically meaningful (>30%) improvements in primary (physical functioning) and secondary (pain effects, emotional functioning, role functioning) outcomes at post-treatment.

We hypothesise that:
(a) The Youth Pain Course will result in improvements in physical functioning at the completion of treatment;
(b) The Youth Pain Course will result in improvements in pain effects (intensity, frequency, affect and cognitions), emotional functioning (anxiety and depressions symptoms), and role functioning (quality of life, school presenteeism and absenteeism) at the completion of treatment; and
(c) Improvements on primary and secondary outcomes will be maintained at 3- and 12-months post-treatment.

The secondary objectives of this project are to explore predictors and moderators of treatment response to guide program improvements and research directions. These objectives are exploratory, and no specific hypotheses can be made; however, the results of these analyses will guide the further development, evaluation and eventual deployment of the treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109986 0
Dr Joanne Dudeney
Address 109986 0
Department of Psychology
Faculty of Medicine, Health and Human Sciences
Macquarie University
NSW 2109
Country 109986 0
Australia
Phone 109986 0
+61 2 9850 9464
Fax 109986 0
Email 109986 0
[email protected]
Contact person for public queries
Name 109987 0
Dr Joanne Dudeney
Address 109987 0
Department of Psychology
Faculty of Medicine, Health and Human Sciences
Macquarie University
NSW 2109
Country 109987 0
Australia
Phone 109987 0
+61 2 9850 9464
Fax 109987 0
Email 109987 0
[email protected]
Contact person for scientific queries
Name 109988 0
Dr Joanne Dudeney
Address 109988 0
Department of Psychology
Faculty of Medicine, Health and Human Sciences
Macquarie University
NSW 2109
Country 109988 0
Australia
Phone 109988 0
+61 2 9850 9464
Fax 109988 0
Email 109988 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-identifiable 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 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.
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 to the chief investigator 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. Data can be obtained by e-mailing the chief investigator ([email protected])


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.