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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 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]

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

Condition category

Condition code

Respiratory

Other respiratory disorders / diseases

Mental Health

Studies of normal psychology, cognitive function and behaviour

Human Genetics and Inherited Disorders

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]

Treatment: Other

Intervention code [2]

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]

Resolution of unresolved grief as measured by the Reaction to Diagnosis Interview

Timepoint [1]

At least 2 weeks after the first study intervention

Secondary outcome [1]

Resolution of unresolved grief as measured by the Reaction to Diagnosis Interview

Timepoint [1]

At least 2 weeks after the second intervention

Secondary outcome [2]

Anxiety as measured by the Depression, Anxiety, Stress Scale (DASS)

Timepoint [2]

at the same time that UG was measured (at least 2 weeks after the second intervention)

Secondary outcome [3]

Depression as measured by the Depression, Anxiety, Stress Scale (DASS)

Timepoint [3]

at the same time that UG was measured (at least 2 weeks after the second intervention)

Secondary outcome [4]

Stress as measured by the at the same time that UG was measured

Timepoint [4]

at the same time that UG was measured (at least 2 weeks after the second intervention)

Secondary outcome [5]

Stress as measured by the Parent Stress Index (PSI)

Timepoint [5]

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?

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)

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Princess Margaret Hospital - Subiaco

Recruitment postcode(s) [1]

6008 - Subiaco

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Vertex Pharmaceuticals

Address [1]

50 Northern Avenue, Boston, Massachusetts, United States

Country [1]

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]

None

Name [1]

none

Address [1]

none

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Princess Margaret Hospital Research Ethics Committee

Ethics committee address [1]

Roberts Road, Subiaco, WA, 6008

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

26/01/2016

Approval date [1]

20/04/2016

Ethics approval number [1]

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

Dr Andre Schultz

Address

Perth Children's Hospital
15 Hospital Avenue
Nedlands
WA
6009

Country

Australia

Phone

+61 8 64565422

Fax

[email protected]

Contact person for public queries

Name

Andre Schultz

Address

Perth Children's Hospital
15 Hospital Avenue
Nedlands
WA
6009

Country

Australia

Phone

+61 8 64562222

Fax

[email protected]

Contact person for scientific queries

Name

Andre Schultz

Address

Perth Children's Hospital
15 Hospital Avenue
Nedlands
WA
6009

Country

Australia

Phone

+61 8 64562222

Fax

[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?

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 [email protected]

What supporting documents are/will be available?

Doc. No.	Type	Email
11564	Study protocol	[email protected]
11565	Informed consent form	[email protected]
11566	Ethical approval	[email protected]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	A pilot study of disease related education and psychotherapeutic support for unresolved grief in parents of children with CF.	2022	https://dx.doi.org/10.1038/s41598-022-09463-8

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically