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Trial registered on ANZCTR


Registration number
ACTRN12621001491853p
Ethics application status
Not yet submitted
Date submitted
20/08/2021
Date registered
2/11/2021
Date last updated
9/05/2024
Date data sharing statement initially provided
2/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating behavioural treatments for social skills problems after a brain injury in childhood.
Scientific title
Efficacy and effectiveness of individualised treatment for deficits in social skills (ITSS)
following childhood acquired brain injury (ABI): a randomised controlled trial (RCT)
Secondary ID [1] 305054 0
Nil known
Universal Trial Number (UTN)
N/A
Trial acronym
ITSS (individualised treatment for social skills impairment)
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Acquired Brain Injury 323256 0
Cognitive-executive impairments 323257 0
Social-cognitive impairments 323258 0
Mental health 323259 0
Impacted parent mental health 323260 0
Child/adolescent challenging behaviour 323261 0
Condition category
Condition code
Injuries and Accidents 320828 320828 0 0
Other injuries and accidents
Neurological 320829 320829 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 320830 320830 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants (child or parent(s)) in the ITSS arm of the trial will receive weekly, manualised, clinician-delivered treatment modules, using a video-conferencing platform. These sessions will range from 8-18 weeks, sessions will be recorded, and 10% of session will later be reviewed for quality control. Eligible participants will be randomised in a ratio of 1:5 (1Control group:5 ITSS) to the control group or the treatment group. Once a child‘s baseline assessment is complete, they will be offered one individualised treatment
aligned with their modifiable factor.

1. The Amsterdam Memory and Attention Training for Children (AMAT-C) is a cognitive training program for enhancing children’s attention, memory, and executive functioning skills. The Amat-c is a restorative or direct intervention program and includes three phases of six-week duration. Phase 1 (six weeks) involves training in sustained attention (e.g., focusing on learning to concentrate on one task for a sustained period of time). Phase 2 relates to selective attention (e.g., ignoring distraction) and divided attention (e.g., focusing attention quickly and flexibly). Phase 3 relates to mental tracking and memory and involves techniques to assist memory, including repetition, coding/sorting, and visual imagery. These strategies that underpin memory functioning aim to train and improve immediate, short-term, and long-term memory.

Participants will complete the Amat-c program for 30 min per day for 18 weeks. In addition, families will receive 1 hr of online, clinician-delivered support at the commencement of each training week. During these family sessions, the clinician will initiate a video call, which will involve training and psychoeducation regarding the weekly focus activities and techniques. The clinician will also address any questions or concerns regarding the training activities from the previous week. Following this, the Amat-c program will be delivered by a parent for the rest of the week. Weekly meetings with the clinician will serve as a method of monitoring and evaluation of weekly assigned homework. Parents will also contribute in providing feedback for each session to improve and optimize future adaptations of the program. Successful attendance to sessions and completion of homework activities and written workbook will determine child-and-parent adherence to the treatment (Catroppa, Botchway, Ryan, Anderson, Morrison, Lam, Piazza, Krasts, McIntosh, Khan, & Sood, 2021).

Example: Listening to the clock: Therapist and child stand 4 metres away from the clock, ensuring that both can hear the clock ticking and they count the ticks up to 1. After a training session where the therapist and child complete the task together, the child is given the following instructions:

Instructions: In a minute, I will count to three and say ‘START’. Then, we will both quietly count the clock’s ticking. Once you have heard the clock tick exactly 10 times, say ‘TEN’. I will do the same. We should both say ‘TEN’ at exactly the same time. Do you understand what I mean? Let’s have a practice. Let’s count the clock ticking out loud.

Following this task, if all went well the distance from the clock was increased and the task repeated until the child was not able to complete the exercise any more. The first and the final distance from the clock was measured.

2. The Program for the Education and Enrichment of Relational Skills (PEERS) is an evidence-based social skills treatment program. It comprises weekly instruction, parent-assistance for social coaching, role-playing and modelling, perspective taking questions, behavioural rehearsal, social coaching and homework assignments. The program comprises one 90 minute session per week (approximately 18 mins per day for 5 days) for 14 weeks.

In addition, the families will receive 1 hr of online, clinician-delivered support at the commencement of each training week. During these family sessions, the clinician will initiate a video call, which will involve training and psychoeducation regarding the weekly focus activities and techniques. The clinician will also address any questions or concerns regarding the training activities from the previous week. Following this, the PEERS program will be delivered by a parent for the rest of the week. Weekly meetings with the clinician will serve as a method of monitoring and evaluation of weekly assigned homework. Parents will also contribute in providing feedback for each session to improve and optimize future adaptations of the program. Successful attendance to sessions and completion of homework activities and written workbook will determine child-and-parent adherence to the treatment.

Example: Participants benefit from the interactive weekly classes, which provide the opportunity to practice new skills, during each session and then again at home or in a familiar environment.
1. How to use appropriate conversational skills
2. How to choose appropriate friends
3. How to appropriately use electronic forms of communication
4. How to appropriately use humour and assess humor feedback
5. How to start, enter and exit conversations between peers
6. How to organize successful get-togethers with friends
7. How to be a good sport when playing games/sports with friends
8. How to handle arguments and disagreements with friends and in relationships
9. How to handle rejection, teasing, bullying, rumours/gossip, and cyber bullying
10. How to change a bad reputation

3.The Cool Kids Anxiety Program is a structured 11 session program run over a minimum of 11 weeks that teaches children and their parents how to better manage their child’s anxiety. 1 hour sessions are provided in a one-to-one, telehealth format, by a fully registered psychologist with a previous experience in CBT and training in the intervention prior to the delivery of the program. The participant will work with the same psychologist through all their sessions in the program. The therapy sessions will be held online. All sessions will be audio-taped for clinical supervision purposes and for evaluation of treatment adherence. The structure for the sessions comprises a combination of time with the adolescent alone, parent alone and both adolescent and parents together. A set of handouts and worksheets was developed for each session for participants to work through concepts and serve as visual reminders of the material covered. These materials will be added to a program folder as each session progressed.

Example: 3. Assertiveness Checklist
· Step 1: Get in touch with how you are feeling
· Step 2: Catch your thoughts
· Step 3: Think about how the other person may be feeling
· Step 4: Communicate confidently
· Step 5: Use an “I” message if you need to ask for something

4. .The Signposts program is an evidence-based parent education program that assists parents to identify and manage their child’s challenging behaviour. In Signposts the parent chooses the goals, measures and monitors the child behaviours, chooses the strategies and evaluates the effectiveness. This parenting program is delivered in 13-15 weekly sessions of 2.5 hr each every other week. The clinician delivers the sessions, and in each session provides individualized support in the event that it is needed. Signposts consists of a Workbook, a DVD, and 9 manual modules. The parents are able to take notes during the sessions and a sheet listing the key concepts of the session is provided. To improve adherence with the content of the treatment a checklist with the topics of each session is completed during the sessions (Woods et al., 2010; Chavez-Arana et al., 2017). The provider is a clinical neuropsychologist and a certified Signposts practitioner.
Sometimes these thinking effects may act as triggers (Module 2) for difficult behaviour, but more often thinking effects will exacerbate difficult behaviour already displayed. Suggestions here are primarily directed for Module 4 – planning for better behaviour, it is important for parents to keep in mind the thinking deficits that their children display when developing planned activities routines.**

i. Targeting – impulsiveness/irritability
Get children to play in separate rooms. Ensure that you immediately praise if child plays nicely with sibling. Develop a planned activities routine (module 4) for the situation.
Teach waiting and how to play skills (module 5).
ii. Targeting - attention/concentration
Reduce distraction in your child’s immediate area of study (remove extra pencils, books, etc.). Provide an area that has the least amount of distraction (e.g. away from siblings) and is closest to where instructions can be given. Divide work into small sections, have your child complete one section at a time.

5. Take A Breath Take a Breath is a videoconferencing group intervention for parents of children with a serious or life-threatening illness or injury. It is an early intervention that provides parents with skills to manage the psychological challenges presented by their child’s illness, and is designed to prevent more serious long-term mental health difficulties, across a range of child illness groups. The program utilises Acceptance and Commitment Therapy (ACT) with the rationale that ACT’s key elements of acceptance, mindfulness, values clarification, and goal setting are logical approaches to managing the intrusive thoughts, avoidance, and high levels of emotional arousal seen in parents of children with a serious illness or injury. Five weekly consecutive parent mediated group sessions (1.5 hours in duration each, totalling 7.5 hours) for parents of children with ABI (with one booster session - 1.5 hours in duration one month following the fifth session). The program is based on social learning principles and will utilize an acceptance and commitment therapy approach.
Intervention code [1] 321450 0
Behaviour
Intervention code [2] 321451 0
Treatment: Other
Comparator / control treatment
Children with acquired brain injury and social impairment will receive usual standard care in the control group. As usual standard care will differ both within and between sites each site will document and describe what is deemed usual care for their patient group.
Examples of usual care include a discharge summary, and outpatient visits with a registered clinician.
Control group
Active

Outcomes
Primary outcome [1] 328628 0
Social Skills Composite Score: to measure overall social competence, using current gold standard tools: Social Interaction [Social Skills Improvement System, SSIS, social skills subscale - communication, cooperation, assertion, responsibility, empathy, engagement, and self-control (a=0.86)], Social Communication [SRS, Social Responsiveness Scale, 2nd Ed, social communication and interaction subscale - social awareness, social cognition, social communication, and social motivation (a=0.96)], Social Participation: [Child and Adolescent Scale of Participation, CASP - home participation, community participation, school participation, and home and community living activities subscales (a >0.96)].
Timepoint [1] 328628 0
Immediately post-intervention, and 6 months post-intervention follow-up
Secondary outcome [1] 399753 0
Cognitive-Executive impairments - using Central Nervous System Vital Signs (CNS Vital), and Behavior Rating Inventory of Executive Function - Second Edition (BRIEF-2)
Timepoint [1] 399753 0
Immediately post-intervention, and 6 months post-intervention follow-up
Secondary outcome [2] 399754 0
Social-Cognitive impairments: using Vineland Adaptive Behavior Scales – Third
Edition (VABS-3), and Paediatric Evaluation of Emotions, Relationships, and Socialisation – Assessment and questionnaire (PEERS-A).
Timepoint [2] 399754 0
Immediately post-intervention, and 6 months post-intervention follow-up
Secondary outcome [3] 399755 0
Child's Mental health : using Child Behavior Checklist (CBCL), and Spence
Children‘s Anxiety Scale (SCAS)
Timepoint [3] 399755 0
Immediately post-intervention, and 6 months post-intervention follow-up
Secondary outcome [4] 399756 0
Child/Adolescents challenging behaviour : using Parenting Stress Index (PSI), and Child Behavior Checklist (CBCL)
Timepoint [4] 399756 0
Immediately post-intervention, and 6 months post-intervention follow-up
Secondary outcome [5] 399757 0
Impacted parent mental health : using The Post Traumatic Stress Disorder Checklist (PCL), and Adult Self-Report (ASR)
Timepoint [5] 399757 0
Immediately post-intervention, and 6 months post-intervention follow-up
Secondary outcome [6] 401130 0
Quality of Life : using Assessment of Quality of Life8D (AQoL-8D), and The Child Health Utility 9D (CCHU-9D)
Timepoint [6] 401130 0
6 months post-intervention follow-up
Secondary outcome [7] 401131 0
ITSS evaluation: using Treatment Evaluation Inventory (TEI-SF)
Timepoint [7] 401131 0
6 months post-intervention follow-up

Eligibility
Key inclusion criteria
1. Confirmed ABI diagnoses (TBI; stroke, brain tumour, cerebral infection)
2. Children 8-16 years at recruitment
3. Minimum of 6 months post-ABI
4. IQ of 70 or above
5. Presence and nature of social impairment (that is score of >2/3 standard deviation below mean on one or more of the 3 subscales of the of the Social Skills Composite Score (SSCS: primary outcome)
6. Adult parent/guardian proficient in English
Minimum age
8 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Non-English speaking
2. Non-accidental TBI
3. Pre-existing social impairment diagnosis
4. Pre-existing language disorder
5. Pre-existing developmental disorder
6. Prior documented/structured intervention for social impairment
7. Prior involvement in interventions outlined in current proposal

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculations are based on the ability to detect a difference of 2/3 standard deviation or greater on the SSCS between the control arm and each of the five treatment arms. With 80% power and a significance level of p = 0.01 to adjust for multiple comparisons due to the 5 treatment arms and the control arm, we estimate a minimum of 55 participants per treatment group and the control group are required, with a minimum sample size of 330 in total. Across the sites it is anticipated that we will have access to a pool of ~600 children with an ABI present annually. We will screen participants from this pool until we have adequate numbers as per the power analysis and to account for 30% participation attrition across the sites. Therefore, to mitigate the anticipated problem of attrition which is common in clinical trials, we aim to recruit 79 participants per treatment group and the control group, with a total sample of 474 participants. The analysis will be conducted using the intention-to-treat paradigm. Comparisons will be made of immediate-, and 6 months post- treatment outcomes between the treatment and the control groups. Analyses will be conducted using independent sample t-tests (continuous outcomes) or chi-square tests (binary outcomes) to evaluate differences in means and proportions, respectively. Secondary analysis will involve linear and logistic regression to adjust for potential confounders and to explore the effect of potential moderators (e.g., child age, time since injury).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/05/2025
Actual
Date of last participant enrolment
Anticipated
1/09/2028
Actual
Date of last data collection
Anticipated
1/09/2029
Actual
Sample size
Target
474
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA,VIC
Recruitment hospital [1] 20248 0
The Royal Childrens Hospital - Parkville
Recruitment hospital [2] 20249 0
Sydney Children's Hospital - Randwick
Recruitment hospital [3] 20250 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [4] 20251 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 34987 0
3052 - Parkville
Recruitment postcode(s) [2] 34988 0
2031 - Randwick
Recruitment postcode(s) [3] 34989 0
4101 - South Brisbane
Recruitment postcode(s) [4] 34990 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 309451 0
Self funded/Unfunded
Name [1] 309451 0
Country [1] 309451 0
Primary sponsor type
Individual
Name
A/Prof Cathy Catroppa
Address
Level 4 West, Brain and Mind Research, Clinical Sciences
Murdoch Children's Research Institute, The Royal Children's Hospital.
50 Flemington Rd, Parkville, 3052,Victoria.
Country
Australia
Secondary sponsor category [1] 310418 0
None
Name [1] 310418 0
Address [1] 310418 0
Country [1] 310418 0
Other collaborator category [1] 281945 0
Individual
Name [1] 281945 0
Prof Justin Kenardy
Address [1] 281945 0
The University of Queensland
McElwain Building (24A), 24 Campbell Rd, St Lucia QLD 4067
Level 4, Room 408,
Country [1] 281945 0
Australia
Other collaborator category [2] 281946 0
Individual
Name [2] 281946 0
A/Prof Carmela Pestell
Address [2] 281946 0
Room 1.23 School of Psychological Science • M304, Perth WA 6009 Australia
The University of Western Australia
35 Stirling Highway
Perth WA 6009 Australia
Country [2] 281946 0
Australia
Other collaborator category [3] 282025 0
Individual
Name [3] 282025 0
Prof Suncica Lah
Address [3] 282025 0
Clinical Psychology Unit, School of Psychology
The University of Sydney
Room 318, Level 3, Brain and Mind Centre, 94 Mallet St, Camperdown NSW 2050
T +61 2 9351 2648, F +61 2 9114 4376
Country [3] 282025 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 309244 0
The Royal Children's Hospital Human Resources Ethics Committee
Ethics committee address [1] 309244 0
50 Flemington Rd, Parkville, Victoria, 3052.
Ethics committee country [1] 309244 0
Australia
Date submitted for ethics approval [1] 309244 0
31/03/2025
Approval date [1] 309244 0
Ethics approval number [1] 309244 0

Summary
Brief summary
ABI can be defined as damage to the brain sustained after birth which is not of a congenital or genetic nature. It is a leading cause of death and disability in children and adolescents, with a global incidence rate of ~ 47-280 per 100,000 children. In Victoria alone, more than 1000 children a year present with an ABI, with the most common causes including traumatic brain injury (TBI) (from falls, sports, vehicular accidents), child stroke and cancer, infection and hypoxicischaemic events. Bierbaum et al reported that, in Australia over a 10-year period, ABI related hospitalisations of children aged 16 years or younger have cost the health system close to half a billion dollars, with life-long health implications for the child and their family. Injury to the brain in childhood has significant consequences, primarily impaired cognition, communication, behaviour, social skills and overall quality of life.

Despite the consequences of childhood ABI, implementation of robust childhood ABI treatments to improve social skills is currently hindered by imprecise understanding of the mechanisms underpinning the social domain,
a lack of high quality evidence and a focus on generic approaches, treating only a single domain, despite children‘s varied behavioural impairment profiles. Disappointingly, the exciting potential for applying a targeted approach addressing modifiable factors unique to the individual‘s social profile has not been attempted. ITSS will address this gap and improve child outcomes after ABI by delivering evidence-based individualised treatment (ITSS), tailored to the child’s needs.

Cognition. The Amsterdam Memory and Attention Training for Children (AMAT-C) is a
treatment for deficits in children‘s attention, memory and executive skills commonly associated with impaired social skills following ABI.

Social cognition. The Program for the Education and Enrichment of Relational Skills (PEERS)
is an evidence-based treatment that has shown efficacy in improving social cognition and social competence in children with neurodevelopmental and socio-emotional disorders, with improvements observed in social knowledge, peer-engagement, and friendships.

Mental Health: Anxiety/depression. The Cool Kids Anxiety Program (COOL KIDS is an
evidence based structured Cognitive Behavioural Therapy (CBT) treatment, with a focus on
anxiety.

Parenting. The Signposts Program for Building Better Behaviour (Signposts) is an evidence-based parent education CBT treatment program that assists parents to identify and manage their child‘s challenging behaviours.

Parental mental health. Take a Breath is a treatment on Acceptance Commitment Therapy
aimed to reduce persisting parent anxiety and stress in the context of child illness/injury.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 113470 0
A/Prof Cathy Catroppa
Address 113470 0
50 Flemington Rd, Parkville, Victoria, 3052.
The Murdoch Children's Research Institute
Country 113470 0
Australia
Phone 113470 0
+61 03 99366638
Fax 113470 0
Email 113470 0
[email protected]
Contact person for public queries
Name 113471 0
Cathy Catroppa
Address 113471 0
50 Flemington Rd, Parkville, Victoria, 3052.
The Murdoch Children's Research Institute
Country 113471 0
Australia
Phone 113471 0
+61 03 99366638
Fax 113471 0
Email 113471 0
[email protected]
Contact person for scientific queries
Name 113472 0
Cathy Catroppa
Address 113472 0
50 Flemington Rd, Parkville, Victoria, 3052.
The Murdoch Children's Research Institute
Country 113472 0
Australia
Phone 113472 0
+61 03 99366638
Fax 113472 0
Email 113472 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
All data will be de-identified. Datasets will be stored as per the Royal Children's Hospital's ethics requirements. All de-identified individual participant data will not be available for this study.


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.