Introduction

Between 23% and 50% of children and adolescents with acquired brain injuries (ABIs)1 2 and 33%–45% of those with cerebral palsy (CP)3 4 experience difficulties with social functioning. Challenges with social problem-solving, speech and pragmatic language, regulation of emotional responses, reduced social opportunities and persistent motor and sensory impairments can limit social participation, resulting in social isolation.3 5 6 Compared with young people without brain injuries, they are 1.7 times more likely to be bullied at school, 1.52 times more likely to have elevated psychological distress, 2.45 times more likely to be medicated for anxiety, depression or both and 3.39 times more likely to attempt suicide.7 Effective interventions to improve social outcomes for adolescents with brain injuries are therefore essential.

Our recent systematic review and meta-analysis of group-based social skills interventions for adolescents with disabilities identified 16 randomised controlled trials (RCTs) of which 15 studies comprised adolescents with Autism and 1 focused on brain tumour survivors.8 Meta-analyses found that group social skills interventions compared with wait list/care as usual led to significantly improved social responsiveness (mean difference, MD −9.61, 95% CI –13.64, –5.69; p<0.001 on the Social Responsiveness Scale), social skills (SMD 0.38, 95% CI 0.1, 0.65; p=0.007 on Social Skills Improvement System (SSIS) Rating Scales), social functioning (MD 3.45, 95% CI 1.33, 5.56; p=0.001 on the Adaptive Behaviour Assessment System) and social knowledge (MD 7.43, 95% CI 5.36, 9.5; p<0.001 on the Test of Adolescent Social Skill Knowledge).8 The most commonly evaluated group social skills programme was the Programme for the Education and Enrichment of Relational Skills (PEERS). There is evidence that PEERS may be effective for young people with other diagnoses, such as attention deficit and hyperactivity disorder.9 As children with brain injuries frequently experience similar difficulties with social functioning, PEERS might be an effective intervention to improve social functioning in this group.

Recently, we conducted the first-ever RCT of PEERS with 36 adolescents with ABI and CP and demonstrated significant improvements in social knowledge and participation.10 Adolescents who completed PEERS compared with the control group demonstrated improved social knowledge measured on the Test of Adolescent Social Skills Knowledge (TASSK, MD=6.8, 95% CI=4.8, 8.8, p<0.001) which was maintained at the 26-week retention time point (MD=8.1, 95% CI=6.0, 10.2, p<0.001). PEERS, compared with the control group, led to a significant increase in parent-reported invited get-togethers at 26 weeks (incidence rate ratio=4.0, 95% CI=1.0, 16, p=0.05).10

Acknowledging that many adolescents do not reside in metropolitan areas where PEERS could be accessed and also reflecting on the significant interruptions to service delivery due to the COVID-19 pandemic, a telehealth delivered PEERS programme may offer a unique solution that would enable equity of access to this programme. Preliminary evidence for telehealth delivered PEERS has demonstrated significant gains in social knowledge, social responsiveness and number of invited and hosted get-togethers for youth with Autism,11 12 with effect sizes equivalent to face-to-face delivered PEERS.12 These studies, however, are limited as they were not RCTs and not tested with adolescents with brain injuries. There is some evidence that other telehealth delivered interventions (eg, ‘Teen Online Problem Solving’) are feasible and effective for youth with brain injuries; however, this was delivered in an individual format,13 and it is unclear the feasibility of group delivered telehealth for this population. The aim of this new study, therefore, is to pilot test the short and long-term efficacy of telehealth delivered PEERS for adolescents with brain injuries to improve social functioning in a pragmatic parallel waitlist RCT. Our secondary aim is to determine acceptability, feasibility, cost and contextual factors impacting the implementation of telehealth PEERS.

Methods and analysisAims and hypotheses

A single-site mixed-methods RCT aims to determine the short-term and long-term efficacy of a telehealth delivered PEERS programme on social functioning for adolescents with brain injuries. This RCT will investigate whether a 14-week telehealth delivered PEERS programme compared with UC will lead to greater changes in social functioning in adolescents with acquired and congenital brain injuries (herein called brain injuries). We aim to explore the acceptability and feasibility of participation in telehealth delivered PEERS, fidelity, costs and identify factors influencing the implementation of telehealth PEERS.

Primary hypothesis (efficacy component).

Compared with care as usual, adolescents receiving PEERS will achieve significantly greater gains in:

Self-perceived performance of social participation goals immediately postintervention (14 weeks) on the Canadian Occupational Performance Measure (COPM) of 2 points or greater.

Secondary hypotheses (efficacy component).

In adolescents with brain injuries, the PEERS telehealth programme compared with the control group will result in:

Greater self-perceived satisfaction with social participation goals on the COPM.

Greater caregiver reported social skills and competence (SSIS Social Emotional Learning edition, SSIS-SEL).

Greater adolescent reported social skills (SSIS-SEL).

Greater parent-reported frequency of get-togethers with peers (Quality of Socialisation Questionnaire, QSQ).

Greater student self-reported knowledge of social skills (TASSK).

Reduced episodes of bullying and victimisation (Multidimensional Peer-Victimisation Scale (MPVS)).

Greater self and caregiver-proxy reported quality of life (KIDSCREEN-27 and parent-reported Child Health Utility–CHU9).

Decreased parent-reported behavioural and emotional problems (Strengths and Difficulties Questionnaire–SDQ).

Increased caregiver-reported knowledge, skills and confidence in coaching their child (Caregiver Social Coaching Questionnaire (CSCQ) for PEERS).

Retention of outcomes 3 months and 9 months postintervention.

Caregivers and participants will report a high degree of acceptability and feasibility of the telehealth PEERS programme (focus groups).

Implementation outcomes

The primary aim is to determine acceptability and feasibility of implementing telehealth PEERS. The secondary aim is to determine fidelity, cost and identify contextual barriers and facilitators to implementation.

Trial design

Telehealth PEERS is a mixed-methods study with a pragmatic parallel waitlist randomised two-group, pretest, post-test study (T0–T1 over 14 weeks), inclusive of a 26 and 52 weeks post baseline follow-up. This approach is proposed as RCTs are considered a ‘gold standard’ for evaluating therapeutic effectiveness.14 In total, 32 youth will be recruited and randomised to either receive the social skills training immediately or waitlist UC. The waitlist group will then go on to receive telehealth PEERS after the 26-week retention time point as per figure 1. This approach could be considered more ethical, as all persons involved are provided with the opportunity to experience the intervention.

Figure 1

Consolidated Standards of Reporting Trials study flow chart. PEERS, Programme for the Education and Enrichment of Relational Skills.

The qualitative aspect of this study will be guided by an interpretive description approach.15 This approach uses inductive reasoning to identify patterns and relationships to create a conceptual understanding of an experience.

Recruitment

Families with a child meeting the eligibility criteria will be invited to join the study. We will begin to recruit 32 children with brain injuries (and their caregiver) across Queensland, Australia. Participants will be recruited through the outpatient clinics and clinical database at the Queensland Children’s Hospital Paediatric Rehabilitation Service and via the research database at the Queensland Cerebral Palsy and Rehabilitation Research Centre.

Inclusion criteria

Participants eligible for the trial must meet the following eligibility criteria: (1) diagnosis of ABI (at least 6 months post-ABI) or CP, (2) between 11 and 17 years and attending mainstream high school, (3) their caregiver reports they have difficulties with social competency, (4) they are motivated to develop friendships, (5) have a verbal IQ>70 measured on the Wechsler Abbreviated Scale of Intelligence second Edition (WASI-II), (6) they and their caregiver have sufficient proficiency in English (able to complete written questionnaires, engage in content of PEERS and focus groups) and are able to commit to the pre and post assessments, 14 weekly sessions and complete homework tasks and (7) they and their caregiver have self-reported access to reliable internet and technology through a smartphone, computer or tablet. Participants will be excluded if the child has uncontrolled epilepsy, severe visual or auditory impairment or is non-verbal.

Procedures

All potential participants will undergo a screening procedure to determine eligibility and motivation to participate in the study. Following screening, if deemed eligible, informed consent will be gained. All participants will complete baseline measures before being randomised to receive either a 14-week programme of Telehealth PEERS immediately or to a waitlist UC group. All participants will complete outcome measures at 14 weeks (immediately post) and then 3 months later (26 weeks post baseline). The waitlist group will then receive Telehealth PEERS. On the final session of Telehealth PEERS, separate focus groups will be conducted with the adolescent and parent groups. All assessment timepoints are detailed in figure 1.

Screening procedure

Intake procedures and screening for eligibility will follow guidelines outlined in the PEERS manual. This includes a 10–15 min telephone screen. During the screening call, the programme will be described, and dyads (adolescent and caregiver) will be informed of the associated risks (eg, social discomfort) of participating in the programme. Following the initial telephone screen, an online screening interview (50 min in total comprising 5 min greeting adolescent and family; 20 min adolescent interview and 20 min parent interview; 5 min wrap up) will take place. This process is important to determine the adolescent’s motivation to develop friendships and discuss the commitment required to complete the telehealth PEERS programme. The programme is described, and the adolescent is asked, “Does this sound like something you would be interested in participating in?” as outlined in the PEERS manual.

Random allocation and blinding

Dyads will be randomised to either receive PEERS immediately or waitlist UC. The waitlist group will go on to receive telehealth PEERS after the 3-month retention time point. A computer-generated random number sequence with concealed allocation will be used. The allocation sequence will be generated by a biostatistician not involved in the study. The allocation will be placed in consecutively numbered opaque envelopes by non-study personnel. Allocation will not be revealed until all baseline assessments have been completed. Participants and therapists delivering the intervention will not be blinded to intervention after baseline assessments, as it will not be possible to maintain blinding while they are delivering the intervention. As all of the outcome measures are questionnaire based and either self-completed or proxy completed, blinding of assessors is not possible. Participants and groups will be given a numerical identifier in the dataset, which will not be revealed to statisticians and chief investigators until analysis is completed.

InterventionsTelehealth PEERS groupDose

24 hours for each for adolescents and caregivers over 14 weeks. This will be achieved through:

Separate weekly 1.5-hour telehealth adolescent and caregiver group sessions (45 min PEERS, 15 min break, 30 min PEERS).

Three 1-hour telehealth individual dyad sessions (at commencement, midway and end of the 14-week programme) to establish goals, review progress and problem-solve and provide support towards each participants’ goals achievement.

Mode

Group with up to eight and a minimum of four adolescents and caregivers in separate groups.

Content and tailoring

The content of the PEERS programme includes entering and exiting conversations, use of electronic communication and social media, conversational skills, appropriate use of humour, organising get-togethers, sportsmanship, handling disagreements, teasing and bullying. The core intervention elements include didactic instruction, observing role play videos, participating in role plays with social coaches (18 years or older) in breakout rooms and discussion of homework tasks. Social coaches assist with role plays, providing prompts and performance feedback. In this study, a social coach with CP or ABI will be included in each adolescent group to bring their lived experience of navigating social situations with a disability and for the potential benefit to the adolescents of seeing people with disabilities working as part of the research team. Modifications for telehealth include homework options for virtual or in-person get-togethers and extracurricular activities, and content for the didactic component of the programme will be delivered using PowerPoint.11 Tailoring will include the provision of electronic cue cards to support working memory and learning of the weekly social rules and behaviours. The caregiver group includes review of homework tasks and facilitated problem-solving to coach their adolescent in social situations.

Intervention providers

The adolescent group and parent group will each be led by two therapists. Intervention providers will be occupational therapists, speech pathologists, social workers or psychologists who have experience delivering the PEERS programme. Two undergraduate occupational therapy, speech pathology, social work or psychology students or young people with lived experience of CP or ABI will act as social coaches in the adolescent group under the direction of senior therapists. Social coaches were required to commit to attendance of at least 80% of the sessions. A minimum of one group leader will be a certified PEERS instructor who has completed the 3-day training and will provide guidance to therapists who have not received training.

Location

Telehealth platform using Zoom with breakout rooms for smaller within-group activities.

Usual care

UC is highly variable and not standardised. It is expected that participants in the waitlist UC group could receive a range of therapies including physiotherapy, occupational therapy, speech pathology and psychology which is frequently offered on a fortnightly basis. The type of therapy and amount is dependent on each child’s funding package through the National Disability Insurance Scheme Queensland in Australia. It is unlikely that the focus of these therapies would be on social skills delivered in a group setting.

Efficacy outcomes and evaluation

Four measurement time points will be taken: baseline (T1); immediately postintervention at 14 weeks post baseline primary endpoint (T2); 26 weeks post baseline retention (T3) and 52 weeks post baseline retention (T4). Children allocated to the waitlist group will be offered Telehealth PEERS following the 26 weeks retention time point. The assessment schedule is outlined in table 1.

Table 1

Schedule of assessments for telehealth PEERS study

Screening and descriptive measuresWechsler Abbreviated Scale of Intelligence, Second Edition

Verbal intelligence will be measured using the WASI-II screener at an initial screening appointment online. Verbal IQ will be determined by the composite score of the vocabulary and similarities subtests. Raw scores from the two subtests are then converted to T scores and summed to form the composite score using age normative data (mean 100, SD 15). The WASI-II has evidence for validity and reliability.16 In the event that a recent neuropsychology assessment has been completed (within 12 months prior), permission will be sought from the caregiver to share data, so as to avoid unnecessary assessment burden. If the neuropsychologist at the Queensland Paediatric Rehabilitation Service considers that the participant would have improved from a previous assessment, the WASI-II will be readministered.

Primary outcomes at primary endpoint (T2)Canadian occupational performance measure

Perceived performance and satisfaction with individualised social participation goals will be measured using the COPM.17 Goals included participatory constructs of attendance and involvement in social situations18 or were related to specific social skills the participants wanted to improve on. Test–retest reliability is high (Intraclass Correlation Coefficient (ICC) 0.76–0.89)17 and the COPM is responsive to change in trials with youth with brain injuries.19 20

Secondary outcomesSSIS-SEL edition

The SSIS-SEL edition is a range of online questionnaires (teacher, parent and student) assessing social skills and competence in adolescents from multiple perspectives. The 46 (student form) and 51 (parent form) item questionnaire versions will be used. The adolescent’s primary caregiver will complete the relevant parent version of the SSIS-SEL, and the adolescent will complete the self-report version. The SSIS-SEL yields competency scores for (1) self-awareness; (2) self-management; (3) social awareness; (4) relationship skills and (5) responsible decision making and an overall composite scaled standard score (mean 100, SD=15). The SSIS-SEL was standardised on 4700 children aged 3–18 years in 36 states in the USA. The SSRS-SEL has evidence for high internal consistency for the (α=0.89–0.97), test–retest reliability (r=0.73–0.91).21

Quality of Socialisation Questionnaire

The 12-item questionnaire will be completed by the child’s caregiver. The QSQ measures the frequency of hosted and invited get-togethers over the previous month and level of conflict during get-togethers.22 The frequency of invited and hosted get-togethers will be reported separately. Based on our previous study, we anticipate that the conflict score may not be able to be calculated as, at baseline, many adolescents may not have attended any hosted or invited get-togethers in the previous month.10 There are no psychometric data available for the QSQ; however, this measure has been frequently used in previous studies of PEERS and was included so as to have a point of comparison.

Test of Adolescent Social Skills Knowledge–Revised

The 30-item self-report questionnaire was developed to measure the participant’s knowledge related to specific skills taught through the didactic lessons in the PEERS.23 Scores range from 0 to 30, with higher scores reflecting greater social skills knowledge. This measure lacks psychometric data, but was included as it has been used in all clinical trials of PEERS and directly captures knowledge related to the content of the programme.

Multidimensional Peer-Victimisation Scale

MPVS is a 16-item measure with 4 subscales assessing physical (eg, ‘punched me’) and verbal (eg, ‘called me names’) victimisation, social manipulation (eg, ‘tried to get me into trouble with my friends’) and property attacks (eg, ‘took something of mine without permission’).24 In the revised version of the MPVS, five additional questions were added to assess experience of electronic aggression.25 Items are rated on a 3-point Likert scale to determine how often the child experiences a behaviour (1=not at all to 3=more than once). Items are summed, with higher scores indicating greater peer victimisation. It is suitable for youth 11–16 years of age. It has good internal consistency for each subscale (0.73–0.85).24

KIDSCREEN-27

KIDSCREEN-27 is a generic measure of health-related quality of life. It has five Rasch scaled dimensions: (1) physical well-being, (2) psychological well-being, (3) autonomy and parent relations, (4) peers and social support and (5) school environment. Each item is rated on a 5-point Likert scale ranging from 1 (not at all) to 4 (very much). A total KIDSCREEN score is calculated by adding up all items with higher scores indicating better quality of life and social support. Parents and adolescents will fill out separate versions of the KIDSCREEN-27. The KIDSCREEN-27 has good internal consistency (α>0.70), evidence of construct validity with moderate to high correlations with health-related quality of life measures (r2=0.39–0.63) and structural and cross-cultural validity.26 27

Child Health Utility Index

CHU-9D is a paediatric health-related generic child quality of life measure. The CHU-9D28 will be completed by the child’s parent and takes approximately 5 min to complete.28

Strengths and Difficulties Questionnaire

The SDQ is a 25-item behavioural screening questionnaire for young people aged 2–17. The SDQ is divided between five scales, including emotional symptoms, conduct problems, peer relationship problems, hyperactivity/inattention and prosocial behaviour and takes approximately 3–5 min to complete. Caregivers will complete the parent version of the SDQ, which demonstrates strong psychometric properties, including adequate test–retest reliability and internal consistency (α=0.80).29

CSCQ for PEERS

CSCQ for PEERS is a self-report questionnaire containing 10 items. The CSCQ takes approximately 3–5 min to complete and measures a caregiver’s knowledge, skills and confidence in coaching their child in various social situations and environments. Caregivers’ responses for the 10 items are rated on a Likert scale from 1 (strongly disagree) to 7 (strongly agree).

Efficacy analysisSample size estimation and justification

A total of 32 participants, 16 in each group, will be recruited to pilot test the programme. This sample size will give us 80% power to detect a 2-point difference (clinically meaningful difference)17 on the primary outcome, The COPM, assuming an SD of 230 with α=0.05 and buffering for 10% attrition.

Statistical methods to be undertaken

Analyses will follow standard principles for RCTs, using two-group comparisons on all participants on an intention-to-treat basis. Intention-to-treat analysis will be employed to reduce bias and ensure that all participants allocated to either the intervention (PEERS for Telehealth) or control group are analysed together as representing that ‘treatment arm’ whether or not they received the intervention or completed the study. The primary comparison H1 immediately post the intervention at 14 weeks will be based on the COPM and will be between treatment groups using generalised linear models. Secondary analyses will use similar methods to compare the outcomes between groups for secondary outcomes. It is hypothesised that the telehealth PEERS intervention will bring positive outcomes in terms of self-perceived occupational performance, social skills and competence, conflict score, knowledge related to specific skills, peer victimisation, and health-related quality of life.

This study will also estimate the cost of telehealth PEERS from a health system perspective. The costs of delivering the intervention will be estimated through a microcosting approach.

Implementation outcomes and evaluation

Penetration will be determined by the number of all participants who are approached for this intervention, who commence the programme, complete the programme or decline the programme. Reasons for non-participation will be sought and documented. A priori determined penetration includes: (a) eligibility: 80% of eligible participants will consent to participate; (b) 90% of consented participants complete the programme and (c) retention: <15% of consented participants will be lost to follow-up.

Acceptability, satisfaction and feasibility of telehealth PEERS will be evaluated with children with CP and ABI and their families and includes aspects of delivery, content, complexity and relative advantage.31 Focus groups will be conducted separately with adolescents and caregiver groups at the final PEERS session (week 14). A semistructured interview schedule will be used to gain participants’ perspectives regarding the acceptability and feasibility of telehealth PEERS. The focus groups will be conducted by a researcher in the team not involved in delivering the PEERS intervention. Focus groups will be audio recorded on Zoom and transcribed verbatim. An iterative, inductive process will be followed using the principles outlined by Thorne.15 Once themes are generated from this inductive analysis, deductive analysis will be undertaken to map findings against the Consolidated Framework for Implementation Research32 and Theoretical Domains Framework33 to understand barriers and facilitators to implementation of telehealth PEERS.

An issues register will be developed to record any technical, logistical difficulties, participant, service delivery or organisational issues arising in the implementation of telehealth PEERS.

Fidelity

A research assistant will monitor fidelity and complete weekly fidelity checklists developed specifically for the PEERS programme. The following outcomes will be collected: (a) dose of intervention (number of telehealth PEERS attended); (b) number of homework tasks completed; (c) percentage of weekly content delivered as intended. An a priori cut-off score for high fidelity of delivery was established as >80%, moderate as ≥50%–80% and low <50% of content delivered.34 35

Cost of implementation

Resource use will be collected and reported on the pilot programme to inform wider implementation and future cost-effectiveness analyses. This includes the cost of the redesign of the programme to a telehealth delivered platform and ongoing maintenance and redesign. Staff time will be captured alongside the fidelity checklists and costed using appropriate wage rates for locality and experience of staff. The costs will be reported disaggregated and in categories so that the costs specific to the research can be attributed and separated from expected UC.

Data monitoring, management and storage

The project information will be stored, accessed, transferred, extracted and destroyed in the following formats: (1) Data collected (eg, by means of initial screening, dyad goal setting/review sessions) will be kept in separate files per dyad. Files will be kept in a secure locked cabinet within the Queensland Cerebral Palsy and Rehabilitation Research Centre, South Brisbane Australia. (2) Group telehealth PEERS for adolescent sessions will be recorded via Zoom. Videos of each session will be transferred to a secure drive at The University of Queensland by a research team member after the session. (3) Deidentified computer files (eg, word document and excel spreadsheets) of participant data, assessment results and goals will be stored on a secure drive at The University of Queensland for comparison and analyses. All researchers involved will have access via secure online login. (4) At the completion of the study, data will be archived as per the Children’s Health Queensland Research Ethics guidelines and institutional protocol.

Participant safety and withdrawalRisk management and safetyRisks and risk minimisation procedures

There is a low chance and low impact physical risk for adolescents associated with participating in social skills activities. At no time will an adolescent be made to participate if they do not choose to do so. There is a low to moderate risk of social discomfort when participating in social skills activities and social coaching opportunities in a group setting. This risk will be minimised by including strategies such as setting group ‘rules’ regarding respect, collaboration and ensuring the safety of each other. Social skills activities will have the capacity to be dynamically adjusted throughout the session and/or programme to match each adolescent’s ability and provide a ‘just right’ challenge. Activities will be challenging but achievable with effort and scaffolded to ensure success. This aims to promote feelings of success and greater social valorisation. There is a low to moderate risk for adolescent and caregiver psychological discomfort with reflecting on their own or adolescent’s physical, psychosocial health and well-being, social goals and challenges through screening, assessment and dyad occupational therapy sessions. Psychological harms will be minimised, as adolescents and caregivers will have the opportunity to withdraw from the study at any stage voluntarily.

Adverse event reporting

Any adverse events or near misses will be documented and followed up in accordance with site-specific requirements and institutional procedures.

Handling of withdrawals

Participants can withdraw at any time. Participants/parents are informed that on withdrawal from the study they have the option to have data already collected either destroyed (all information collected about the participant can no longer be used for research) or retained (information collected about the participant can continue to be used for research).

Replacements

Participants who withdraw will not be replaced, as the a priori power calculation will account for a 10% dropout rate.

Patient and public involvement

Focus groups were conducted with 27 adolescents and 31 caregivers following our previous face-to-face PEERS programme.10 This has informed a number of key changes for the telehealth version of PEERS:

Inclusion of three individual sessions to further individualise/tailor PEERS and address specific social challenges experienced,

Updating content on technology,

Inclusion of goal-setting tool for social participation goals, and

Modifying homework and allowing additional time for completion.

Individual stakeholder engagement with young people with ABI and their caregivers has additionally informed the structure of the telehealth PEERS programme. Consumer preferences include maintaining the ‘group’ format, including a 15 min break in the middle of the 90 min telehealth session, and allowing time at the commencement of each group to enable parents to help their adolescent set up the weekly Zoom sessions.

A stakeholder reference group will be established including a person with lived experience and a caregiver of a child with brain injuries, end users (service provider in both the public and private sector, service manager and National Injury Insurance Scheme Queensland representative) which will meet 2–3 times yearly throughout the trial to provide input and feedback to trial conduct.

Discussion

This paper details the protocol for a mixed-methods study with a pragmatic RCT to determine the efficacy of a telehealth delivered PEERS programme compared with UC to improve social competence for adolescents with brain injuries. We hypothesise that a telehealth delivered PEERS intervention compared with UC will lead to significantly greater gains in social goal attainment on the COPM, caregiver and self-reported social skills on the SSIS-SEL, increased frequency of invited and hosted get-togethers (QSQ), increased adolescent knowledge of social skills (TASSK), reduced frequency of peer victimisation (MPVS) and greater self and caregiver reported health-related quality of life (KIDSCREEN-27). In addition, we will explore participants’ experiences of participation in telehealth PEERS and collect process-related outcomes to inform implementation of the programme in clinical practice.

Based on results from our previous face-to-face delivered PEERS groups and consumer feedback, we have added additional outcome measures. Importantly, we have added an individualised goal-setting measure in order to better capture the priorities of adolescents and caregivers in their own community contexts, along with measures of peer victimisation and health-related quality of life. The addition of three personalised individual dyad sessions will further aim to provide greater individualisation and tailoring to meet participants’ goals. We have included an additional assessment time point in order to fully understand the longer-term impact of the PEERS intervention.

One potential limitation of the study is the ongoing challenge of measuring social functioning and reliance on self and proxy-reported questionnaires; however, there are limited options for reliable direct observational measures. Another limitation is that UC will be highly variable and cannot be standardised as there are multiple service providers under pre-agreed funding packages through the Australian National Disability Insurance Scheme. Given the lack of evidence for social skill group programmes for this population, it is unlikely that the control group would receive a similarly targeted intervention. The requirement for an adolescent to be at least 6 months post-ABI was reasoned to be responsive to clinical need to provide rehabilitation for social functioning while acknowledging that natural recovery is likely to still be occurring during this time. In addition, the diversity of stage of recovery in this group and time of injury is acknowledged as a potential limitation. Limiting the inclusion criteria to adolescents attending mainstream high school in Australia was made to reduce further variability and was seen as in line with verbal IQ minimum requirements.

The study has a number of limitations and strengths. The sample size, although relatively small, has been calculated for the primary outcome (social goal attainment). We will seek participant feedback and collect process-related outcomes to inform translation of findings into clinical practice. We acknowledge that the use of telehealth as a service delivery model will be potentially impacted by issues of poor internet connectivity which may influence acceptability and feasibility of delivery. This method of service delivery, however, has the potential to allow equity of access to individuals living in resource-limited settings. Findings of this study will provide evidence of the efficacy of a telehealth delivered PEERS programme and the inclusion of implementation outcomes will inform future research aimed at translating Telehealth PEERS into clinical practice We plan that results of this RCT will be disseminated widely through peer-reviewed journals and academic conferences.