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Trial registered on ANZCTR


Registration number
ACTRN12619000161123p
Ethics application status
Not yet submitted
Date submitted
29/01/2019
Date registered
4/02/2019
Date last updated
4/02/2019
Date data sharing statement initially provided
4/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title

A Cognitive Behavioural intervention for parents of children with Arthritis
Scientific title
Impact of a Cognitive Behavioural intervention for parents of children with Juvenile idiopathic Arthritis on parental behaviour and functioning: a pilot study
Secondary ID [1] 297222 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Juvenile Idiopathic Arthritis 311285 0
Condition category
Condition code
Musculoskeletal 309897 309897 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 309996 309996 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Parents will be randomly allocated into groups of 6-8 and invited to attend four, two-hour sessions of group Cognitive Behavioural Therapy (CBT) at the Murdoch University Psychology Clinic. The sessions will be conducted weekly and will be delivered by the student researcher, who is currently undertaking the second year of a Masters of Clinical Psychology. Training and supervision will be available from Dr Vance Locke, a Clinical Psychologist with significant experience in working with individuals with chronic pain. Structure of the intervention will be as followed;

Session 1:
Prior to commencement of the intervention, the aims and processes of the research will be discussed, allowing time for participants to ask questions if needed. Following this, participants will be asked to sign consent forms. Following this, pre-intervention data will be collected as participants will be required to fill out pre-intervention self-report measures. Participant adherence will be monitored by logging down their attendance each session.

Session structure
· Parents will be provided psychoeducation on the difference between acuteand chronic pain and will beintroduced to the chronic pain cycle.
· Parents will be provided with psychoeducation around pain and will be assisted in understanding factors that have an influence on pain through a bio-psycho-social perspective.
Factors that will be discussed:
· Physiological response to pain and threat
· Pain related thoughts/beliefs- catastrophizing thoughts
· Fear of pain and the fear-avoidance model of pain.
· Unhelpful coping
· Parents will be provided psychoeducation on the impact of stress on chronic pain
Session 2:
· Parents will be provided psychoeducation on pharmacological treatments of chronic pain
· Parents will be encouraged to understand the importance of managing chronic pain through a bio-psychosocial perspective.
· Parents will be educated about the biopsychosocial approach to pain management and learn strategies of how they can support their children using this approach.
Strategies that will be discussed:
· Challenging unhelpful thoughts/beliefs about pain (catastrophizing thoughts/fear of pain)
· Helpful coping – Relaxation, PACING.

Session 3:
· Pain will be introduced in a social context, looking at how other people may influence how their child perceives their pain.
· Parents will be educated about the interaction between parent-child that may impact on the child’s pain.
The following will be discussed;
·Parental response to child pain.
·Positive/negative reinforcement of pain
·Protective behaviours
·Child/adolescent autonomy.
· Parents will be provided an opportunity to learn and develop skills that will foster positive interactions with their children, that will reduce the likelihood of increasing children’s pain and disability.
Session 4:
· Parents will be provided education on the role of pain in the family – how it may place restrictions to the parent’s own life, marital and financial difficulties, and mood.
· Parents will be educated about the interactions between parents- parental distress, mental health and support.
· Parents will be introduced to the concept of helping their child by helping themselves-looking at self-care and social support.

1. Two days after intervention completion, participants will be emailed post-intervention questionnaires and will be asked to complete the questionnaires and mail/email them back to the researchers within a 7 day period.
Intervention code [1] 313477 0
Behaviour
Comparator / control treatment
No control group
This is a pilot study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 318837 0
Composite Primary outcome 1: Impact of parenting a child with chronic pain on the parent (Depression, anxiety, child-related catastrophizing, self-blame and helplessness, partner relationship, leisure functioning, parental behaviour and parental strain)
- The Bath Adolescent Pain- Parent Impact Questionnaire (BAPQ-PIQ)
Timepoint [1] 318837 0
- Time point: 1- Baseline- Commencement of intervention (prior to session 1)
- Time point 2- 7 days following intervention end
Primary outcome [2] 318839 0
Primary outcome 2: Parental psychological functioning
- The Depression and Anxiety Stress Scale (DASS-21)
Timepoint [2] 318839 0
Time point: 1- Baseline-Commencement of intervention (prior to session 1)
- Time point 2- 7 days following intervention end
Primary outcome [3] 318841 0
Primary outcome 3: Parental fear of pain
- Fear of pain Questionnaire-parent report (FOPQ-P)
Timepoint [3] 318841 0
- Time point: 1- Baseline-Commencement of intervention (prior to session 1)
- Time point 2- 7 days following intervention end
Secondary outcome [1] 366215 0
Composite Secondary Outcome 1.
Composite secondary outcome 1:
Impact of chronic pain on child outcomes
(Social functioning, physical functioning, depression, general anxiety, pain specific anxiety, family functioning and development)
- The Bath Adolescent Pain Questionnaire- Parent report. (BAPQ-P)
Timepoint [1] 366215 0
- Time point: 1- Baseline- Commencement of intervention (prior to session 1)
- Time point 2- 7 days following intervention end
Secondary outcome [2] 366344 0
Primary outcome 4:
- Adult Responses to Child Symptoms (ARCS)- parent form
Timepoint [2] 366344 0
- Time point: 1- Baseline- Commencement of intervention (prior to session 1)
- Time point 2- 7 days following intervention end

Eligibility
Key inclusion criteria
Parent of a child with juvenile Idiopathic arthritis. The parent should be a caregiver of the child and currently reside with the child.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Parent cannot speak or read in 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)
Open (masking not used)
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
Prior to data analysis, the dataset will be screened for univariate and multivariate outliers and for missing data. Missing data can be assessed with statistical methods such as Little’s Missing Completely at Random (MCAR) Test. If missing data are identified, researchers will discuss whether imputations or other statistical procedures for dealing with missing data are appropriate and should be undertaken. It is likely that an Analysis of Variance (ANOVA) will be used to examine change in treatment outcomes over time. Bonferonni corrections will be performed due to there being multiple dependent variables. Finally, effect sizes, mean differences, and 95% confidence intervals will be calculated. Researchers will use IBM SPSS Statistics to run all the descriptive and inferential statistics.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2019
Actual
Date of last participant enrolment
Anticipated
1/04/2019
Actual
Date of last data collection
Anticipated
1/09/2019
Actual
Sample size
Target
34
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 25475 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 301770 0
University
Name [1] 301770 0
Murdoch University
Country [1] 301770 0
Australia
Primary sponsor type
University
Name
Murdoch University
Address
Murdoch University
90 South Street, Murdoch, Western Australia 6150
Country
Australia
Secondary sponsor category [1] 301515 0
None
Name [1] 301515 0
Address [1] 301515 0
Country [1] 301515 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 302488 0
Murdoch University Human Research Ethics Committee
Ethics committee address [1] 302488 0
Ethics committee country [1] 302488 0
Australia
Date submitted for ethics approval [1] 302488 0
13/02/2019
Approval date [1] 302488 0
Ethics approval number [1] 302488 0

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

Contacts
Principal investigator
Name 90394 0
Dr Vance Locke
Address 90394 0
Discipline of Psychology
College of Science, Health, Engineering and Education (SHEE)
Murdoch University
90 South Street, Murdoch WA 6150
Country 90394 0
Australia
Phone 90394 0
+61 89360 6931
Fax 90394 0
+61 8 9360 6878
Email 90394 0
v.locke@murdoch.edu.au
Contact person for public queries
Name 90395 0
Anna Gavrilova
Address 90395 0
Discipline of Psychology
College of Science, Health, Engineering and Education (SHEE)
Murdoch University
90 South Street, Murdoch WA 6150
Country 90395 0
Australia
Phone 90395 0
+61 89360 2570
Fax 90395 0
+61 8 9360 6878
Email 90395 0
Anna.Gavrilova@murdoch.edu.au
Contact person for scientific queries
Name 90396 0
Vance Locke
Address 90396 0
Discipline of Psychology
College of Science, Health, Engineering and Education (SHEE)
Murdoch University
90 South Street, Murdoch WA 6150
Country 90396 0
Australia
Phone 90396 0
+61 89360 6931
Fax 90396 0
+61 8 9360 6878
Email 90396 0
v.locke@murdoch.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Given the small numbers of participants and the population of parents of children with JIA, there is an increased risk of people being identifiable from the data.


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.