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Trial registered on ANZCTR


Registration number
ACTRN12621000796886
Ethics application status
Approved
Date submitted
3/05/2021
Date registered
24/06/2021
Date last updated
24/06/2021
Date data sharing statement initially provided
24/06/2021
Date results information initially provided
24/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Unresolved grief in parents of children with cystic fibrosis (CF): A pilot randomised controlled trial on the use and delivery sequence of disease-related education and psychotherapeutic support
Scientific title
Unresolved grief in parents of children with CF: A pilot randomised controlled trial on the use and delivery sequence of disease-related education and psychotherapeutic support
Secondary ID [1] 304119 0
none
Universal Trial Number (UTN)
n/a
Trial acronym
n/a
Linked study record
n/a

Health condition
Health condition(s) or problem(s) studied:
Unresolved grief in relation to a child's diagnosis of cystic fibrosis
 321802 0
Condition category
Condition code
Respiratory 319528 319528 0 0
Other respiratory disorders / diseases
Mental Health 319529 319529 0 0
Studies of normal psychology, cognitive function and behaviour
Human Genetics and Inherited Disorders 319846 319846 0 0
Cystic fibrosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention One (insight-oriented therapy; IOT): five one-hour sessions of IOT spread out within a minimum of five weeks. For pragmatic reasons and to maximise participation, no specific maximum timeframe indicated between measurement of unresolved grief (UG) and the study interventions. Participants will only move to the next part of the study after all five one-hour IOT sessions have been completed.
What is involved in the IOT: One-on-one sessions with a clinical psychologist delivering IOT focused on assisting parents to gain a deeper understanding of the impact of their unresolved grief (UG) surrounding their child’s diagnosis on their day-to-day coping, their interpersonal relationships, and their distress surrounding the future of their child with the aim of bringing about psychological change which would lead to a sense of resolution in relation to their child’s CF diagnosis.
Mode of therapy: one-on-one in-person session with a clinical psychologist
Strategies to monitor adherence: Participants will only move to the next part of the study after all five one-hour IOT sessions have been completed.
After the above, outcomes measured and participants exposed to Intervention Two (comparator treatment described below)
Intervention code [1] 320453 0
Treatment: Other
Intervention code [2] 320730 0
Behaviour
Comparator / control treatment
Intervention Two (disease related education; hereafter ‘education’): five one-hour sessions of CF related education spread out over a period of at least five weeks.

For pragmatic reasons and to maximise participation, no specific maximum timeframe indicated between measurement of UG and the study interventions. Participants will only move to the next part of the study after all five one-hour IOT sessions have been completed.

Education provided by experienced members of a CF care team including a paediatric respiratory physician, CF nurse, physiotherapist, gastroenterologist and dietician providing one-on-one information sessions about their areas of expertise in CF. Sessions allow for questions from parents, and the information provided was tailored to parents’ needs. The education sessions aim to address basic CF related information that parents may not have been open to at initial meetings with the clinical CF care team shortly after having been informed about the diagnosis, and that may not have been re-visited with subsequent routine clinical care visits. The overall setting of education sessions -optimistic and caring.

Education sessions conducted in a one-on-one format with the participant and the expert. Participants only progress to the next stage of the study after all 5 sessions completed.

After the above, outcomes measured and participants exposed to Intervention One described above.
Control group
Active

Outcomes
Primary outcome [1] 327396 0
Resolution of unresolved grief as measured by the Reaction to Diagnosis Interview
Timepoint [1] 327396 0
At least 2 weeks after the first study intervention
Secondary outcome [1] 394941 0
Resolution of unresolved grief as measured by the Reaction to Diagnosis Interview
Timepoint [1] 394941 0
At least 2 weeks after the second intervention
Secondary outcome [2] 396325 0
Anxiety as measured by the Depression, Anxiety, Stress Scale (DASS)
Timepoint [2] 396325 0
at the same time that UG was measured (at least 2 weeks after the second intervention)
Secondary outcome [3] 396326 0
Depression as measured by the Depression, Anxiety, Stress Scale (DASS)
Timepoint [3] 396326 0
at the same time that UG was measured (at least 2 weeks after the second intervention)
Secondary outcome [4] 396327 0
Stress as measured by the at the same time that UG was measured
Timepoint [4] 396327 0
at the same time that UG was measured (at least 2 weeks after the second intervention)
Secondary outcome [5] 396328 0
Stress as measured by the Parent Stress Index (PSI)
Timepoint [5] 396328 0
at the same time that UG was measured (at least 2 weeks after the second intervention)

Eligibility
Key inclusion criteria
Parent of a child with cystic fibrosis aged 6 months - 18 years with unresolved grief as diagnosed with Reaction to Diagnosis Interview
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Living in a geographical location too far from the hospital (study site) to allow participation in the study.

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)
No
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomized by the hospital pharmacy (external to the study team) in blocks of four using simple randomisation using a randomisation table from a statistic book.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The study and research question are primarily parallel in nature, thus the study is designated as a parallel study. However, following the initial intervention and measurement of outcomes, participants were given access to the alternative treatment. This may make the study appear to be a cross over study, however, the decision to give each participant the opportunity to experience both interventions was based on recommendations from clinicians in the hospital’s CF service who felt it best all participants were able to experience the IOT component of the research as these parents had no other means of directly accessing such a service through the paediatric hospital setting.

“The outcome of interest (UG) and the interventions do not align with the requirements of a cross over trial (no anticipated return to baseline, practical washout period cannot remove education etc), hence despite giving the participants access to both interventions, we primarily focus of the first period of randomised intervention.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics calculated for the full sample and per arm. Basic between-group comparisons (at post and follow-up time-points) using a Chi-squared test or a Student’s T test, as appropriate.
The primary analysis of whether UG become resolved, assessed using a logistic regression model, with an odds ratio (OR) and 95% confidence interval (95% CI) reported for the odds of grief resolving in the IOT arm relative to the ED arm. For the other outcomes (mental health measures), data from the end of the first period (post) analysed using a linear regression ANCOVA framework, where the post-time-point measurement the dependent variable and the pre-time-point measurement included as an independent variable in the model. All regression models adjusted for gender of the parent, age of the parent, duration of grief, and, where appropriate the initial measurement of the dependent variable for the period of analysis.
The secondary analysis of the follow-up time-point data carried out via two different approaches; firstly, via the same framework as for the primary outcome using only data from the post- and follow-up time-points in place of the pre- and post-time-points (respectively) and, secondly, using data from the pre- and follow-up time-points using a ‘sequence’ variable to quantify overall change based on sequence of interventions.
Because of the exploratory nature of this pilot study, the analysis focus on the statistical significance of the between group (intervention) differences and instead focuses on the magnitude of effects and variability; p-values are presented for some comparisons as a further quantification of comparison of the observations against the underlying hypothesis of no difference between groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
17/05/2016
Date of last participant enrolment
Anticipated
Actual
22/12/2016
Date of last data collection
Anticipated
Actual
21/12/2017
Sample size
Target
32
Accrual to date
Final
22
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 19259 0
Princess Margaret Hospital - Subiaco
Recruitment postcode(s) [1] 33839 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 308498 0
Commercial sector/Industry
Name [1] 308498 0
Vertex Pharmaceuticals
Country [1] 308498 0
United States of America
Primary sponsor type
Hospital
Name
Princess Margaret Hospital for Children
Address
Roberts Road, Subiaco, 6008, WA
Country
Australia
Secondary sponsor category [1] 309349 0
None
Name [1] 309349 0
none
Address [1] 309349 0
none
Country [1] 309349 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308458 0
Princess Margaret Hospital Research Ethics Committee
Ethics committee address [1] 308458 0
Roberts Road, Subiaco, WA, 6008
Ethics committee country [1] 308458 0
Australia
Date submitted for ethics approval [1] 308458 0
26/01/2016
Approval date [1] 308458 0
20/04/2016
Ethics approval number [1] 308458 0
RGS2520

Summary
Brief summary
Background: Diagnosis of chronic disease in a child can result in unresolved grief (UG) in parents.
Aims: to evaluate efficacy of psychological insight-oriented therapy (IOT) as a treatment for UG compared to disease related education in parents of children with cystic fibrosis (CF). Sequence of delivery, first IOT then disease related education (or vice versa) also examined, to let all participants experience both interventions.
Methods: Parents screened for UG. Parents with UG randomised to either five one-hour sessions of IOT or five one-hour sessions of education. Measures assessed pre-intervention, after the first intervention period (primary efficacy assessment), and after the second intervention period (swapping intervention).
Primary outcome measure: resolution of grief as measured by the Reaction to Diagnosis Interview.
Secondary outcome measures: Anxiety, Stress, Depression as measured by the Depression, Anxiety, Stress Scale (DASS), and the Parent Stress Index (PSI).
Trial website
none
Trial related presentations / publications
none
Public notes
none

Contacts
Principal investigator
Name 110758 0
Dr Andre Schultz
Address 110758 0
Perth Children's Hospital
15 Hospital Avenue
Nedlands
WA
6009
Country 110758 0
Australia
Phone 110758 0
+61 8 64565422
Fax 110758 0
Email 110758 0
andre.schultz@health.wa.gov.au
Contact person for public queries
Name 110759 0
Dr Andre Schultz
Address 110759 0
Perth Children's Hospital
15 Hospital Avenue
Nedlands
WA
6009
Country 110759 0
Australia
Phone 110759 0
+61 8 64562222
Fax 110759 0
Email 110759 0
andre.schultz@health.wa.gov.au
Contact person for scientific queries
Name 110760 0
Dr Andre Schultz
Address 110760 0
Perth Children's Hospital
15 Hospital Avenue
Nedlands
WA
6009
Country 110760 0
Australia
Phone 110760 0
+61 8 64562222
Fax 110760 0
Email 110760 0
andre.schultz@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
database: individual participant data of published results only
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication;
Available to whom?
researchers who provide a methodologically sound proposal
Available for what types of analyses?
only to achieve the aims in the approved proposal
How or where can data be obtained?
access subject to approvals by Principal Investigator andre.schultz@health.wa.gov.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11564Study protocol  andre.schultz@health.wa.gov.au
11565Informed consent form  andre.schultz@health.wa.gov.au
11566Ethical approval  andre.schultz@health.wa.gov.au



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA pilot study of disease related education and psychotherapeutic support for unresolved grief in parents of children with CF.2022https://dx.doi.org/10.1038/s41598-022-09463-8
N.B. These documents automatically identified may not have been verified by the study sponsor.