Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12625001304426
Ethics application status
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Approved
Date submitted
Help: Date submitted
7/11/2025
Date registered
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24/11/2025
Date last updated
Help: Date last updated
24/11/2025
Date data sharing statement initially provided
Help: Data sharing statement date
24/11/2025
Type of registration
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Prospectively registered

Titles & IDs
Public title
SIBS-ONLINE: Pilot of an online psychosocial program for siblings and parents of patients with severe neurological impairments
Scientific title
Feasibility, acceptability and effect of an online psychosocial program (SIBS-ONLINE) on communication and mental health for siblings and parents of patients with severe neurological impairments: A pilot study
Additional trial identifiers [1] 314187 0
None
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Mental health 337051 0
Severe neurological conditions 339741 0
Developmental and epileptic encephalopathies (over 900 associated genes e.g., Dravet Syndrome, Lennox-Gastaut Syndrome, West syndrome) 339742 0
Childhood dementia (e.g., Batten disease, Rett syndrome, Niemann-Pick type-C, Sanfilippo syndrome) 339743 0
Condition category
Condition code
Mental Health 333497 333497 0 0
Other mental health disorders
Human Genetics and Inherited Disorders 333498 333498 0 0
Other human genetics and inherited disorders
Neurological 335996 335996 0 0
Epilepsy

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Brief description: SIBS-ONLINE is an online, cognitive behavioural therapy based intervention for siblings and parents of individuals with chronic illness. It was developed in 2023 by a team of Norwegian researchers and underwent a randomised controlled trial.

Delivery: SIBS-ONLINE consists of six online sessions delivered over six weeks (i.e., one session per week for each participant). Each session will range from 20-60 minutes long. SIBS-ONLINE is delivered on a secure, password-protected video-conferencing platform (e.g. Microsoft Teams or Zoom). Therefore, sibling and parent participants can join from anywhere in Australia.

Materials used:
As recommended by the SIBS-ONLINE developers, the sibling and parent group sessions will have no more than 6 sibling-parent dyads. Depending on recruitment, we will aim to join participants whose family member has the same or similar diagnosis. A standardised manual developed by the Norwegian team (and translated to English) will be followed by the group leaders during the sessions. The manual describes the purpose and structure of each SIBS-ONLINE session, the role of each group leader in facilitating and strategies to encourage productive conversation and troubleshoot common issues that may arise.

Parents and siblings will engage in four sessions (session 1, 2, 4 and 6) separately from their family member in sibling and parent groups. The sibling sessions will focus on discussing their emotions, thoughts, and feelings about their sibling’s developmental and epileptic encephalopathy (DEE) or other severe neurological condition and writing down questions they have about those illnesses for their parents. The parent sessions focus on communication training, using video examples of 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 other participants in their respective groups. This is the shortest session, at around 20 minutes. For siblings, the second session will focus on learning about their siblings’ illness, sharing thoughts and writing any question(s) they have for their parents. For parents, the second 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.

A week after each group has had their separate second session, a joint session will be conducted with parents and siblings in breakout rooms. 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 personalised feedback on their communication skills.

A week after the joint session, parents and siblings will reconvene in their groups for a third 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 a week later where the siblings present their challenges to the parents who further practise their learned communication skills.

A final, sixth sessions will be held to conclude the program with all the siblings and parents together. Group leaders will recap what they have learnt and achieved through the program. Siblings and parents will have the opportunity to ask questions and provide feedback about the program as well.

Who will deliver the program?: The program is administered by two group leaders, and a third group leader will be present to manage any significant distress that arises. Group leaders will be students or researchers who have received comprehensive training in how to deliver SIBS-ONLINE as well as Mental Health First Aid training. The third group leaders will be a senior researcher or clinician with experience working with families of patients with severe illnesses. All group leaders will complete comprehensive training in how to deliver the SIBS-ONLINE program, including online modules and three full days of face-to-face learning and role playing. These training sessions will be led by Norwegian researchers who were prominent in the development of SIBS and SIBS-ONLINE in late February 2026, approximately two to four weeks prior to commencement of intervention.

Intervention adherence: Parents and siblings of individuals with severe neurological conditions are busy and may have unpredictable schedules, thus, part of the aim of this trial is to assess how feasible the program is to complete. To assess group leader adherence to the intervention, The Competence and Adherence Scale for Cognitive Behavioural Therapy (CAS-CBT) will be used. The CAS-CBT is an 11-item scale developed to measure adherence to treatment protocol and facilitator competency in manualized CBT treatment for young people. SIBS-ONLINE group leaders will complete a template at the end of each session where they will rate themselves for each CAS-CBT item on a 0-6 scale (“none” to “thorough” for adherence, “poor” to “excellent” for skills). The psychometric properties of the CAS-CBT have been demonstrated on a Norwegian sample – the CAS-CBT has a high level of internal consistency (Cronbach’s alpha of 0.87), and a high level of within-rater stability (r=>0.89). Additionally, a random 10% sample of the recorded SIBS-ONLINE sessions will be reviewed by a clinical supervisor external to the research team for group leader adherence to the program manual.


Intervention code [1] 330792 0
Behaviour
Description of the comparator or control
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341075 0
Feasibility of the intervention (recruitment rates)
Timepoint [1] 341075 0
During recruitment of participants prior to the 6-week intervention. Population level data assessed at the conclusion of the study.
Primary outcome [2] 343524 0
Feasibility of the intervention (data collection)
Timepoint [2] 343524 0
Post completion of each survey (i.e., T1, T2) after the 6-week intervention.
Primary outcome [3] 343525 0
Feasibility of the intervention (adherence)
Timepoint [3] 343525 0
Assessed after completion of the intervention period for all participants.
Secondary outcome [1] 454700 0
PRIMARY: Feasibility of the intervention (attrition)
Timepoint [1] 454700 0
Assessed at the conclusion of data collection.
Secondary outcome [2] 454701 0
PRIMARY: Feasibility of the intervention (resources required for the intervention)
Timepoint [2] 454701 0
Some data documented after participant completion of each survey (T0 prior to the 6-week intervention and T1 immediately after and T2 3-months after the 6-week intervention). All other data documented during the 6-week intervention after each session and compiled and assessed after the intervention period ends.
Secondary outcome [3] 454702 0
PRIMARY: Acceptability of the intervention (quantitative)
Timepoint [3] 454702 0
Completed in the post-intervention survey (T1) immediately after completion of the 6-week intervention.
Secondary outcome [4] 454703 0
PRIMARY: Acceptability of the intervention (qualitative)
Timepoint [4] 454703 0
Interviews will be completed at a time that is acceptable to participants after completion of the 6-week intervention. This may be in any time period from immediately post 6-week intervention (T1) to before completion of the follow-up questionnaire (T2).
Secondary outcome [5] 454704 0
Mental health for siblings (sibling report).
Timepoint [5] 454704 0
Immediately before the 6-week intervention (T0), immediately after the 6-week intervention (T1), and 3 months after the 6-week intervention (T2)
Secondary outcome [6] 454705 0
Mental health of siblings (parent-report)
Timepoint [6] 454705 0
Immediately before the 6-week intervention (T0), immediately after the 6-week intervention (T1), and 3 months after the 6-week intervention (T2)
Secondary outcome [7] 454706 0
Emotional distress (parents)
Timepoint [7] 454706 0
Immediately before the 6-week intervention (T0), immediately after the 6-week intervention (T1), and 3 months after the 6-week intervention (T2)
Secondary outcome [8] 454707 0
Family Communication (sibling-report)
Timepoint [8] 454707 0
Immediately before the 6-week intervention (T0), immediately after the 6-week intervention (T1), and 3 months after the 6-week intervention (T2)
Secondary outcome [9] 454708 0
Family Communication (parent-report)
Timepoint [9] 454708 0
Immediately before the 6-week intervention (T0), immediately after the 6-week intervention (T1), and 3 months after the 6-week intervention (T2)
Secondary outcome [10] 454709 0
Sibling illness knowledge
Timepoint [10] 454709 0
Immediately before the 6-week intervention (T0), immediately after the 6-week intervention (T1), and 3 months after the 6-week intervention (T2)
Secondary outcome [11] 454710 0
Emotional parent-child communication
Timepoint [11] 454710 0
Data collected at session five of the 6-week intervention (i.e., 5-weeks into the intervention)

Eligibility
Key inclusion criteria
Sibling participants
• Young people aged between 12 and 18 years old (inclusive)
• Currently living with a sibling who has been diagnosed with a severe neurological impairment (i.e., developmental and epileptic encephalopathies such as Dravet Syndrome, Lennox-Gastuat Syndrome, West Syndrome, childhood dementia such as Batten Disease, Rett Synrome, Sanfilippo syndrome, or related conditions such as Angelman Syndrome) at least 6 months prior;
• Has not been diagnosed with a chronic illness
• Able to give informed consent
• Able to speak and read conversational English
• Must have access to a computer/smartphone/tablet with Internet connection

Parent participants
• A parent/guardian of a participating sibling
• Must be parent/guardian to at least one child diagnosed with a severe neurological impairment at least 6 months prior, who lives at home
• Has not been diagnosed with a chronic illness
• Able to give informed consent
• Able to speak/read conversational English
• Must have access to a computer/smartphone/tablet with Internet connection
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Parents and siblings will 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
- The sibling has a severe neurological impairment or comparable diagnosis
- They have a child/sibling with a chronic illness who was diagnosed less than 6 months prior to the study
- If the person with the DEE has died
- Any parent or sibling is assessed as having severe depression and/or suicidal intent or plan, as determined in the initial intake interview, or by the participant’s responses to the first questionnaire. Participants who report at the initial intake interview that they are currently experiencing serious suicidal intent (with or without a defined plan) will be excluded with appropriate referral options provided. Further, parents who score greater than or equal to 30 on the Kessler Psychological Distress Scale (K10) and siblings who score greater than or equal to 17 on the Strengths and Difficulties Questionnaire at T0 will be telephoned and assessed further to determine whether or not their score is indicative of a ‘severe’ mental health disorder and to assess their suicidal risk. If further assessment indicates a parent or sibling is experiencing a ‘severe’ mental health disorder and/or suicidal risk they will be excluded and provided with appropriate referral options.
- Any parent or sibling who reports that they who reports that they are currently undergoing treatment for Schizophrenia, or who is judged to be currently experiencing a psychotic episode, based on clinical judgment at the initial interview.
- Any parent or sibling who reports substance abuse

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Analysis of quantitative data will be conducted using IBM SPSS, version 25. Frequency statistics will be calculated for demographic and clinical characteristics.

Feasibility and acceptability

Frequency statistics and/or means and standard deviations will be calculated for feasibility outcomes, questions from the participant acceptability survey and group leader acceptability survey. Focus groups to assess the acceptability of the intervention and research conduct will be transcribed verbatim and de-identified by a member of the research team (MS). An inductive thematic analysis approach will be used to generate codes and themes, with six phases of qualitative analysis described by Braun and Clark. Two members of the research team will read and cross-check the transcripts to familiarise themselves with the data set. Using NVivo 15 software, two coders will independently review the transcripts to highlight important data and group data into codes. Coders will meet to discuss their independent codes and develop a codebook. Each coder will re-code the data using this codebook independently and coding discrepancies will be reconciled through team discussion. After all codes are generated and finalized, the research team will meet to identify themes and sub-themes. An abductive approach will be taken to map themes and sub-themes to the seven constructs of the Theoretical Framework of Acceptability (TFA).

Preliminary effectiveness

Quantitative
To assess preliminary effectiveness, the mean, standard deviation and the mean difference (95% confidence intervals) will be calculated for all intervention outcomes (SDQ, PACS, K10) pre, post and 3-months post completing SIBS-ONLINE. For normally distributed changes, paired samples t-tests will be conducted to investigate whether there were significant changes in outcomes between pre, post- and 3-months-post- intervention. For non-normally distributed change scores, the Wilcoxon signed-rank test will be used to evaluate pre- to post-intervention changes. P-values less than .05 will be considered statistically significant.

Qualitative
Answers to the open-ended question to assess sibling illness knowledge will be coded using the framework method for analysis of qualitative data (Lewis et al., 2007) using Microsoft Excel. This approach provides the ability to compare data across cases and within individual cases. The data does not need to be transcribed, so two coders will begin by familiarising themselves with the data. As described by Tuthill and colleagues, in Excel, a table will be created for each participant to find patterns across time and various themes. The rows of the table are labelled as ‘participant encounters’ (i.e., pre-intervention, post-intervention and 3-months post-intervention), and the columns are themes identified from coding. A deductive approach will be used to code the data based on pre-existing codes such as ‘name of condition,’ ‘understanding symptoms’ etc. However, coders will also use inductive approaches to generate codes for unexpected aspects of knowledge that arise. Two coders will independently populate the table with data from each participant. Once all time points have been collected for each participant, the research team can explore themes across time for each participant to analyse change in knowledge or expression of knowledge. A second matrix will be populated where each row represents a participant, and each column represents the identified themes. For each theme, researchers will populate the identified themes from each participant’s original matrix (i.e., improvement in knowledge).

We will also conduct an in-depth qualitative analysis using NVivo software of emotional parent-child communication from sessions, as done by the team in Norway (Haukeland et al., 2022). Parent-child communication will be analyzed with the Verona Coding Definitions of Emotional Sequences (VR-CoDES) which is a well-established, reliable and widely used tool developed to study emotional communication in medical encounters (Piccolo et al., 2017). A cue is defined as an ambiguous verbal or nonverbal hint, suggesting an underlying unpleasant emotion and a concern is defined as a clear expression of an unpleasant emotion. Further, cues and concerns can be elicited (prompted by one person in the conversation) or initiated (introduced by one person in the conversation). Sessions 5 of SIBS-ONLINE will be transcribed verbatim for each sibling-parent dyad, as this included the dual conversation. Two researchers (MS and JH) will review and deductively code transcripts independently to identify emotional cues and concerns from siblings. Differences in coding will be reconciled through discussion and if consensus cannot be reached, a third researcher (LK) will be consulted. Once cues and concerns are identified, the same two authors will code each transcript for responses to cues and concerns from the parent, using the VR-CoDES framework to identify whether a response was implicit or explicit and whether it provided space or reduced space for further emotional discussion. Every cue/concern has a response, even if the response is ignoring. Next, the two researchers will complete exploratory inductive coding to analyse the content of the cues and concerns, including listening, exploring and validating behaviours that are learnt during the intervention. The first 3 transcripts will be iteratively coded to develop a codebook for content that is agreed upon by both researchers. From there, each transcript will be independently coded, reconciling any differences through discussion between coders.

Braun V, Clarke V. Using thematic analysis in psychology. Qualitative research in psychology. 2006;3(2):77-101.
Lewis J. Analysing qualitative longitudinal research in evaluations. Social Policy and Society. 2007;6(4):545-56.
Tuthill EL, Maltby AE, DiClemente K, Pellowski JA. Longitudinal Qualitative Methods in Health Behavior and Nursing Research: Assumptions, Design, Analysis and Lessons Learned. Int J Qual Methods. 2020;19.
Haukeland YB, Fjermestad KW, Mossige S, Vatne TM. Parent-child communication about emotions during SIBS: a joint intervention for siblings and parents of children with chronic disorders. Nordic Psychology. 2022;74(3):205-21.
Piccolo LD, Finset A, Mellblom AV, Figueiredo-Braga M, Korsvold L, Zhou Y, et al. Verona Coding Definitions of Emotional Sequences (VR-CoDES): Conceptual framework and future directions. Patient Education and Counseling. 2017;100(12):2303-11.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2026
Actual
Date of last participant enrolment
Anticipated
1/09/2026
Actual
Date of last data collection
Anticipated
12/01/2027
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 319509 0
Government body
Name [1] 319509 0
NHMRC Centres of Research Excellence
Country [1] 319509 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Country
Australia
Secondary sponsor category [1] 321753 0
None
Name [1] 321753 0
Address [1] 321753 0
Country [1] 321753 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317311 0
The University of New South Wales Human Research Ethics Committee Executive
Ethics committee address [1] 317311 0
Ethics committee country [1] 317311 0
Australia
Date submitted for ethics approval [1] 317311 0
28/08/2025
Approval date [1] 317311 0
27/10/2025
Ethics approval number [1] 317311 0

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

Contacts
Principal investigator
Name 140658 0
Dr Lauren Kelada
Address 140658 0
Randwick Clinical Campus, Discipline of Paediatrics & Child Health, UNSW Sydney, NSW, 2031
Country 140658 0
Australia
Phone 140658 0
+61 0438 557 599
Fax 140658 0
Email 140658 0
[email protected]
Contact person for public queries
Name 140659 0
Lauren Kelada
Address 140659 0
Randwick Clinical Campus, Discipline of Paediatrics & Child Health, UNSW Sydney, NSW, 2031
Country 140659 0
Australia
Phone 140659 0
+61 0438 557 599
Fax 140659 0
Email 140659 0
[email protected]
Contact person for scientific queries
Name 140660 0
Lauren Kelada
Address 140660 0
Randwick Clinical Campus, Discipline of Paediatrics & Child Health, UNSW Sydney, NSW, 2031
Country 140660 0
Australia
Phone 140660 0
+61 0438 557 599
Fax 140660 0
Email 140660 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.