ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

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

Cognitive-executive impairments

Social-cognitive impairments

Mental health

Impacted parent mental health

Child/adolescent challenging behaviour

Condition category

Condition code

Injuries and Accidents

Other injuries and accidents

Neurological

Other neurological disorders

Physical Medicine / Rehabilitation

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]

Behaviour

Intervention code [2]

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]

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]