Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000177853
Ethics application status
Approved
Date submitted
11/12/2020
Date registered
19/02/2021
Date last updated
2/03/2023
Date data sharing statement initially provided
19/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
SIBS-ONLINE: Pilot of an online program for siblings and parents of children living with chronic illness
Scientific title
SIBS-ONLINE: Pilot of an online program for mental health outcomes of siblings and parents of children living with chronic illness
Secondary ID [1] 303007 0
None
Universal Trial Number (UTN)
U1111-1260-6511
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Illness 320061 0
Pediatric cancer 320403 0
Cystic fibrosis 320404 0
Chronic kidney disease 320405 0
Condition category
Condition code
Mental Health 317990 317990 0 0
Other mental health disorders
Cancer 318306 318306 0 0
Any cancer
Human Genetics and Inherited Disorders 318307 318307 0 0
Cystic fibrosis
Human Genetics and Inherited Disorders 318308 318308 0 0
Other human genetics and inherited disorders
Renal and Urogenital 318309 318309 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The SIBS-ONLINE intervention consists of four sessions delivered through a secure, password-protected video conferencing software on the Internet (e.g. Zoom, Skype, WebEx) by group leaders and two homework and feedback sessions at home. These sessions will be conducted over the course of 4-5 days in a row. Groups The homework and feedback sessions will be conducted using ‘break out rooms’ in the videoconferencing platform so that the parent-sibling dyads have privacy from the rest of the group, and so the group leader can intermittently drop-in on the conversation and provide guidance and feedback.

The first siblings-only and parents-only sessions will last for 80 minutes. The second such sessions will last 60 minutes. The joint parent-sibling sessions will last approximately 50 minutes, with the group leader joining each dyad for approximately 10 minutes each.

We will pilot SIBS-ONLINE with N=30 families (30 siblings and 30 of their parents), conducting five groups with six participants in each group.

Fully trained staff from UNSW and Canteen will conduct the group sessions. Training will consist of two full days of learning about the intervention and role playing. These training sessions will be conducted either face-to-face or via video-conferencing and led by Prof Fjermestad and Dr Vatne. CanTeen Australia are a community organisation who offer individual and group counselling to adolescents and young adults (aged 12-25) with cancer and their families. They have world-class expertise in the provision of tailored counselling services, and have worked extensively with siblings of young people with cancer (please see: https://www.canteen.org.au/young-people/my-brothersister-has-cancer/).

Parents and siblings will engage in sessions with group leaders separately from each other, while homework and feedback sessions will be conducted together. The sibling sessions will focus on discussing their emotions, thoughts, and feelings about their brother or sister’s chronic illness and writing down questions they have about those illnesses for their parents. The parent sessions focus on communication training, using video examples of real sibling-parent dialogues and open-exploratory communication as basis for discussion. Parent sessions also comprise psychoeducation about sibling challenges, and introduction to cognitive-behavioural principles about emotional coping.

Each group’s first session will involve an introduction to the intervention and the other participants in their respective groups. For siblings, the first sessions will also focus on sharing thoughts about their brother/sisters’ illness and writing any question(s) they have for their parents. For parents, the first session will overview and provide information about the intervention as well as exercises which will encourage parents to listen, explore, and validate the siblings’ thoughts about the disorder.
After each group has had their first session, a joint session will be conducted by the parents and siblings at home. The joint sessions will incorporate integrated sibling-parent dialogues in which siblings present their questions and, in turn, parents practise communication skills learned in initial session. Group leaders will intermittently join these conversations, and provide each parent with personalized feedback on their communication skills.

After the joint session, parents and siblings will reconvene in their groups for one more separate session. Siblings will focus on challenging emotions and feelings they have about their brother/sisters’ illness and writing them down to express to their parents. Parents will focus on listening, exploring, and validating emotional challenges. A second joint session will then be held where the siblings present their challenges to the parents who further practise their learned communication skills.

Each group has two group leaders. In SIBS-ONLINE, the same two group leaders will run the sibling and parent groups. Group leaders will 1) be an employee or student of either UNSW or Canteen; 2) hold at least a Bachelor’s degree in psychology or social work, with work experience with mental health; and 3) be trained by the lead investigator to run the groups. Group leaders, in addition running the SIBS-ONLINE groups, will be involved in collecting research data through the completion of templates after each group session

Adherence will be monitored by using attendance checklists. Each group leader will also complete the Competence and Adherence Scale for Cognitive Behavioural Therapy after each session. They will rate themselves for each CAS-CBT item on a 0-6 scale (“none” to “thorough” for adherence, “poor” to “excellent” for skills).
Intervention code [1] 319292 0
Behaviour
Intervention code [2] 319293 0
Treatment: Other
Comparator / control treatment
No control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325995 0
Mental health (Strengths and Difficulties Questionnaire, total difficulties score) for siblings. These scores will be assessed independently.
Timepoint [1] 325995 0
Before intervention, immediately after intervention, and 3 months after intervention
Primary outcome [2] 326277 0
Mental health (Strengths and Difficulties Questionnaire, total difficulties score) for parents. These scores will be assessed independently.
Timepoint [2] 326277 0
Before intervention, immediately after intervention, and 3 months after intervention
Secondary outcome [1] 389797 0
Quality of life (PedsQL) for parents
Timepoint [1] 389797 0
Before intervention and 3 months after intervention
Secondary outcome [2] 389798 0
Distress (Emotion Thermometers) for siblings
Timepoint [2] 389798 0
Before intervention, immediately after intervention, and 3 months after intervention
Secondary outcome [3] 389799 0
Adaption (Negative Adjustment Scale) for siblings
Timepoint [3] 389799 0
Before intervention and 3 months after intervention
Secondary outcome [4] 389800 0
Coping (Kidcope) for siblings
Timepoint [4] 389800 0
Before intervention and 3 months after intervention
Secondary outcome [5] 389801 0
Sibling disorder knowledge (Sibling Knowledge Interview-written version). Completed only by siblings.
Timepoint [5] 389801 0
Before intervention and 3 months after intervention
Secondary outcome [6] 390878 0
Family communication (Parent-Child Communication Scale) for siblings. These scores will be assessed independently.
Timepoint [6] 390878 0
Before intervention, immediately after intervention, and 3 months after intervention
Secondary outcome [7] 390879 0
Family communication (Parent-Child Communication Scale) for parents. These scores will be assessed independently.
Timepoint [7] 390879 0
Before intervention, immediately after intervention, and 3 months after intervention
Secondary outcome [8] 390880 0
Quality of life (PedsQL) for siblings
Timepoint [8] 390880 0
Before intervention and 3 months after intervention
Secondary outcome [9] 390883 0
Distress (Emotion Thermometers) for parents
Timepoint [9] 390883 0
Before intervention, immediately after intervention, and 3 months after intervention

Eligibility
Key inclusion criteria
Inclusion criteria for sibling participants

• Young people aged between 12 and 18 years old (inclusive);
• Currently living with a brother or sister who has been diagnosed with a chronic illness at least 6 months prior;
• Able to give informed consent; and
• Able to speak/read conversational English
• Must have access to a computer/smartphone/tablet and Internet connection

We will include siblings of children with various chronic illnesses, including cancer, developmental disability, cystic fibrosis, kidney diseases, gastrointestinal disorders, and genetic neurological disorders. We aim to recruit across a wide range of chronic illnesses, to determine if SIBS-ONLINE has a broad, trans-diagnostic appeal.

Inclusion criteria for parent participants

• One parent/guardian of each participating sibling will also participate
• Must be parent/guardian to at least one child diagnosed with a with a chronic illness at least 6 months prior, who lives at home
• Able to give informed consent
• Able to speak/read conversational English
• Must have access to a computer/smartphone/tablet and Internet connection
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria for sibling and parent participants

Parents and siblings will be not be eligible to participate if:
• They possess insufficient English language skills to complete and understand the core aims of the study, and to be able to participate in the group sessions
• They display cognitive impairment which may limit their ability to provide reliable questionnaire responses
• They have a child/sibling with a chronic illness who was diagnosed less than 6 months prior to the study
• If the child with the chronic illness is terminal and believed to be imminently dying, or has died
• They indicate serious suicidal intent and/or have a suicidal plan

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
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
Statistical methods / analysis
Sample size calculation

The statistical power of a comparison of paired samples depends on the within-individual correlation over time. A study in Dutch 10-to-14 year-olds estimated a correlation coefficient of 0.87 (95% 0.80–0.91) [Muris et al, 2003)] in the self-reported SDQ total difficulties score over an interval of 2 months. The lower bound of this confidence interval may be considered as a conservative estimate of the correlation that we would expect to see over the much shorter duration of SIBS-ONLINE.
We will pilot SIBS-ONLINE with N=30 families (30 siblings and 30 of their parents), conducting five groups with six participants in each group. Given that the changes within each group will not be independent, the power also depends on the intra-group correlation.

If the within-individual correlation is at least 0.80 and the within-group correlation is no larger than 0.35 (as evidenced in the evaluation of the original Norwegian SIBS intervention for siblings of children with chronic illness [Haukeland et al, 2020]), then a sample size of 30 siblings provides greater than 80% power to detect a large change (0.8 standard deviations) in SDQ total difficulties score, using a two-sided test with a significance level of 0.05.

There is a possibility that multiple siblings, or multiple parents from a family of a child with a chronic illness will want to participate. If this case arises, any data from those participants will be potentially correlated, reducing the effective sample size. For each family that contributes multiple siblings or parents, the target sample size will be increased to ensure that there are at least 30 independent individuals.


Analysis plan

SIBS-ONLINE has a single-arm pre-post design with the primary outcome being the difference in SDQ scores from pre-intervention to immediately post-intervention, reported by siblings and parents. The primary analysis will be a test of the null hypothesis that the mean difference between the paired scores is equal to zero, accounting for within-group correlation by using a repeated-measures regression model with cluster-robust standard errors. The estimated difference will be presented with a two-sided 95% confidence interval.

Analyses of secondary outcomes will be performed in a similar manner, as appropriate for the specific outcome.

In the case where multiple siblings or parents from the same family are included in the study, statistical tests that account for this additional non-independence will be used.

Analyses will be conducted in SPSS.

References
Muris, P., et al., The strengths and difficulties questionnaire (SDQ). 2003. 12(1): p. 1-8.
Haukeland, Y.B., et al., Evaluation of “SIBS”, An Intervention for Siblings and Parents of Children with Chronic Disorders. 2020. 29(8): p. 2201-2217.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
29/03/2022
Actual
Date of last participant enrolment
Anticipated
29/03/2023
Actual
Date of last data collection
Anticipated
29/06/2023
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 18187 0
Sydney Children's Hospital - Randwick
Recruitment postcode(s) [1] 32244 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 307417 0
University
Name [1] 307417 0
UNSW
Country [1] 307417 0
Australia
Funding source category [2] 307418 0
Government body
Name [2] 307418 0
Norwegian National Advisory Unit on Rare Disorders
Country [2] 307418 0
Norway
Primary sponsor type
Other
Name
Behavioural Sciences Unit
Address
The Behavioural Sciences Unit, Kids Cancer Centre
Sydney Children's Hospital, Level 1
High St, Randwick
NSW 2031
Country
Australia
Secondary sponsor category [1] 308083 0
None
Name [1] 308083 0
None
Address [1] 308083 0
None
Country [1] 308083 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307230 0
Sydney Children's Hospitals Network Human Research Ethics Committee
Ethics committee address [1] 307230 0
Ethics committee country [1] 307230 0
Australia
Date submitted for ethics approval [1] 307230 0
25/09/2020
Approval date [1] 307230 0
24/11/2020
Ethics approval number [1] 307230 0
2020/ETH02598

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

Contacts
Principal investigator
Name 106486 0
Dr Lauren Kelada
Address 106486 0
Behavioural Sciences Unit, Kids Cancer Centre, Sydney Children's Hospital, NSW 2031

School of Women's and Children's Health, UNSW Sydney, Kensington, NSW 2033
Country 106486 0
Australia
Phone 106486 0
+61 02 9382 1789
Fax 106486 0
+61 02 9382 1789
Email 106486 0
[email protected]
Contact person for public queries
Name 106487 0
Lauren Kelada
Address 106487 0
Behavioural Sciences Unit, Kids Cancer Centre, Sydney Children's Hospital, NSW 2031

School of Women's and Children's Health, UNSW Sydney, Kensington, NSW 2033
Country 106487 0
Australia
Phone 106487 0
+61 02 9382 1789
Fax 106487 0
+61 02 9382 1789
Email 106487 0
[email protected]
Contact person for scientific queries
Name 106488 0
Lauren Kelada
Address 106488 0
Behavioural Sciences Unit, Kids Cancer Centre, Sydney Children's Hospital, NSW 2031

School of Women's and Children's Health, UNSW Sydney, Kensington, NSW 2033
Country 106488 0
Australia
Phone 106488 0
+61 02 9382 1789
Fax 106488 0
+61 02 9382 1789
Email 106488 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




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.