Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000082606
Ethics application status
Approved
Date submitted
10/01/2023
Date registered
25/01/2023
Date last updated
20/11/2023
Date data sharing statement initially provided
25/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Mixed Methods Randomised Control Trial Of Telehealth Program for the Education and Enrichment of Relational Skills (PEERS®) For Teens with Cerebral Palsy or Acquired Brain Injury
Scientific title
Mixed Methods Randomised Control Trial Of Telehealth Program for the Education and Enrichment of Relational Skills (PEERS®) on Social Skills and Participation in Teens with Cerebral Palsy or Acquired Brain Injury
Secondary ID [1] 307812 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acquired Brain Injury 327396 0
Cerebral Palsy 327397 0
Condition category
Condition code
Physical Medicine / Rehabilitation 324522 324522 0 0
Occupational therapy
Physical Medicine / Rehabilitation 324523 324523 0 0
Speech therapy
Neurological 324524 324524 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This mixed methods RCT of telehealth PEERS® for teens is a telehealth group delivered Program for the Education and Enrichment of Relational Skills (PEERS®) for high-school aged teenagers aged 11–17 years with acquired brain injury (ABI) or cerebral palsy (CP). A concurrent parent group is also run in a different telehealth group. Telehealth PEERS® for teens will be run for groups of 8 youths and their caregivers. Four groups will be run over a two-year period in order to deliver the program to the immediate groups and control groups after the waitlist period. The program uses small online group format of 8 teenagers. It comprises didactic instruction, parent-assistance (social coaching), role playing and modelling, perspective taking questions, behavioural rehearsal, social coaching and invivo homework assignments.

1. Youth telehealth component:
- 14 weekly sessions of 90 minute duration (45 minutes PEERS, 15 minutes break, 30 minutes PEERS).
-content 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.
- three 1-hour telehealth individual dyad sessions (at commencement, midway and end of the 14-week program) to problem solve and provide support towards each participants’ goals achievement.
- no specified time for homework completion - will be dependent on each participant
-up to 8 teens per group
- 2 therapists will lead each group session for teens (IE. Occupational Therapists ((OTs) or a combination of OT/Speech Pathologist (SP))
- A research assistant will monitor fidelity and complete weekly fidelity checklists developed specifically for the PEERS® program. Prior to each session, therapists and social coaches will have a short telehealth meeting to discuss the session outline, content and roles in the groups will be discussed.

2. Parent groups component: includes review of homework tasks and facilitated problem-solving to coach their adolescent in social situations.
- the parent group will run for 1 hour, in order to allow parents time to support their child to set up and join the teen group
-three 1-hour telehealth individual dyad sessions (at commencement, midway and end of the 14-week program) to problem solve and provide support towards each participants’ goals achievement.
-up to 8 parents per group
-2 therapists will lead each group session for parents (IE. OTs or a combination of OT/Social Worker (SW))
A research assistant will monitor fidelity and complete weekly fidelity checklists developed specifically for the PEERS® program. Prior to each session, therapists and social coaches will have a short telehealth meeting to discuss the session outline, content and roles in the groups will be discussed.

3. Focus groups component:
Phase 2: Qualitative study: semi-structured interviews will be conducted by a researcher not involved in the delivery of the intervention separately to participants and caregivers to explore perceived acceptability, feasibility and benefit of the PEERS® program. Interviews will be audiotaped and transcribed. Transcripts will be thematically coded using Leximancer software.
All participants (teens and caregivers) in the trial will be invited to participate in the focus groups.
Intervention code [1] 324278 0
Treatment: Other
Intervention code [2] 324279 0
Behaviour
Comparator / control treatment
Waitlist control group receiving care as usual for 26 weeks and then will be offered telehealth PEERS® for teens. Usual care is highly variable and not standardised. It is expected that participants in the waitlist usual care group could receive a range of therapies including physiotherapy, occupational therapy, speech pathology and psychology. It is unlikely that the focus of these therapies would be on social skills delivered in a group setting.
Control group
Active

Outcomes
Primary outcome [1] 332356 0
Canadian Occupational Performance Measure: Individualised social participation goals will be measured using the Canadian Occupational Performance Measure (COPM) to evaluate self-perceived occupational performance over time. The COPM is responsive to change in trials with youth with brain injuries.
Timepoint [1] 332356 0
Baseline measure will be taken prior to the intervention (T1) then immediately post intervention (T2 - 14 weeks) then 3 months later (T3 - 6 months post baseline) and 9 months later (T4 - 12 months post baseline)
Secondary outcome [1] 413163 0
Kidscreen-27 is a generic measure of health-related quality of life. It has five Rasch scaled dimensions: Physical Well-Being, Psychological Well-Being, Autonomy & Parents, Peers & Social Support and School Environment.
Timepoint [1] 413163 0
Baseline measure will be taken prior to the intervention (T1) then immediately post intervention (T2 - 14 weeks) then 3 months later (T3 - 6 months post baseline) and 9 months later (T4 - 12 months post baseline)
Secondary outcome [2] 413164 0
QSQ-Adolescent: The questionnaire has both parent and adolescent versions. We will only complete the questionnaire with parents, not adolescents. This change was made prior to recruitment commenced.
Timepoint [2] 413164 0
Baseline measure will be taken prior to the intervention (T1) then immediately post intervention (T2 - 14 weeks) then 3 months later (T3 - 6 months post baseline) and 9 months later (T4 - 12 months post baseline)
Secondary outcome [3] 413165 0
Test of Adolescent Social Skills Knowledge (TASSK). The self-report questionnaire was developed to measure the teen’s knowledge related to specific skills taught through the 11 didactic lessons in the PEERS®.
Timepoint [3] 413165 0
Baseline measure will be taken prior to the intervention (T1) then immediately post intervention (T2 - 14 weeks) then 3 months later (T3 - 6 months post baseline) and 9 months later (T4 - 12 months post baseline)
Secondary outcome [4] 413166 0
Multidimensional Peer-Victimization Scale is a 16-item measure with 4 subscales assessing physical and verbal victimization, social manipulation and property attacks. It is suitable for youth 11-16 years of age.
Timepoint [4] 413166 0
Baseline measure will be taken prior to the intervention (T1) then immediately post intervention (T2 - 14 weeks) then 3 months later (T3 - 6 months post baseline) and 9 months later (T4 - 12 months post baseline)
Secondary outcome [5] 413167 0
Parent and teen reported acceptability and feasibility of PEERS® via semi-structured interviews separately with caregivers and teens to explore the lived experience of telehealth PEERS for teens. Interviews will be conducted by a researcher not involved in the delivery of the intervention, audiotaped and transcribed. Transcripts will be thematically coded using Nvivo software.
Timepoint [5] 413167 0
Immediately post intervention (T2 - 14 weeks)
Secondary outcome [6] 429096 0
Social Skills Improvement System Social Emotional Learning (SSIS-SEL) are a range of online questionnaires (teacher, parent, student) assessing social skills and competence in children from multiple perspectives. The child's primary caregiver will complete the 51 item parent questionnaire version of the SSIS-SEL and the results will be assessed independently. The SSIS-SEL was standardised on 4,700 children aged 3 to 18 years in the United States of America. The SSIS-SEL has evidence for high internal consistency for the (a=0.89-0.97), test retest reliability (r=0.73-0.91).24.
Timepoint [6] 429096 0
Secondary outcome [7] 429097 0
Social Skills Improvement System Social Emotional Learning (SSIS-SEL) are a range of online questionnaires (teacher, parent, student) assessing social skills and competence in children from multiple perspectives. The child's primary caregiver will complete the 51 item parent questionnaire version of the SSIS-SEL and the results will be assessed independently. The SSIS-SEL was standardised on 4,700 children aged 3 to 18 years in the United States of America. The SSIS-SEL has evidence for high internal consistency for the (a=0.89-0.97), test retest reliability (r=0.73-0.91).24.
Timepoint [7] 429097 0
Baseline measures will be taken prior to intervention (T1), then immediately following 12 weeks of intervention (T2) then 3 months later (T3 - 6 months post baseline) and 9 months later (T4 - 12 months post baseline)
Secondary outcome [8] 429098 0
Social Skills Improvement System Social Emotional Learning (SSIS-SEL) are a range of online questionnaires (teacher, parent, student) assessing social skills and competence in children from multiple perspectives. The child will complete the self-report version of the SSIS-SEL and the results will be assessed independently. The SSIS-SEL was standardised on 4,700 children aged 3 to 18 years in the United States of America. The SSIS-SEL has evidence for high internal consistency for the (a=0.89-0.97), test retest reliability (r=0.73-0.91).24.
Timepoint [8] 429098 0
Baseline measures will be taken prior to intervention (T1), then immediately following 12 weeks of intervention (T2) then 3 months later (T3 - 6 months post baseline) and 9 months later (T4 - 12 months post baseline)
Secondary outcome [9] 429099 0
Social Skills Improvement System Social Emotional Learning (SSIS-SEL) are a range of online questionnaires (teacher, parent, student) assessing social skills and competence in children from multiple perspectives. The child will complete the self-report version of the SSIS-SEL and the results will be assessed independently. The SSIS-SEL was standardised on 4,700 children aged 3 to 18 years in the United States of America. The SSIS-SEL has evidence for high internal consistency for the (a=0.89-0.97), test retest reliability (r=0.73-0.91).24.
Timepoint [9] 429099 0
Baseline measures will be taken prior to intervention (T1), then immediately following 12 weeks of intervention (T2) then 3 months later (T3 - 6 months post baseline) and 9 months later (T4 - 12 months post baseline)
Secondary outcome [10] 429100 0
The Caregiver Social Coaching Questionnaire for PEERS® [CSCQ for PEERS®] is a self-report questionnaire containing 10 items. The CSCQ takes approximately 3-5 minutes 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).
Timepoint [10] 429100 0
Baseline measures will be taken prior to intervention (T1), then immediately following 12 weeks of intervention (T2) then 3 months later (T3 - 6 months post baseline) and 9 months later (T4 - 12 months post baseline)
Secondary outcome [11] 429101 0
The Caregiver Social Coaching Questionnaire for PEERS® [CSCQ for PEERS®] is a self-report questionnaire containing 10 items. The CSCQ takes approximately 3-5 minutes 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).
Timepoint [11] 429101 0
Baseline measures will be taken prior to intervention (T1), then immediately following 12 weeks of intervention (T2) then 3 months later (T3 - 6 months post baseline) and 9 months later (T4 - 12 months post baseline)
Secondary outcome [12] 429102 0
The Child Health Utility Index (CHU-9D28) is a paediatric health related generic child quality of life measure. It is designed specifically for economic evaluation and has been validated in an Australian population. In this study the CHU-9D28 will be completed by the child's caregiver only.
Timepoint [12] 429102 0
Baseline measures will be taken prior to intervention (T1), then immediately following 12 weeks of intervention (T2) then 3 months later (T3 - 6 months post baseline) and 9 months later (T4 - 12 months post baseline)
Secondary outcome [13] 429103 0
The Child Health Utility Index (CHU-9D28) is a paediatric health related generic child quality of life measure. It is designed specifically for economic evaluation and has been validated in an Australian population. In this study the CHU-9D28 will be completed by the child's caregiver only.
Timepoint [13] 429103 0
Baseline measures will be taken prior to intervention (T1), then immediately following 12 weeks of intervention (T2) then 3 months later (T3 - 6 months post baseline) and 9 months later (T4 - 12 months post baseline)
Secondary outcome [14] 429104 0
The Strengths and Difficulties Questionnaire [SDQ] is a 25-item behavioural screening questionnaire for young people aged 2-17 (Goodman, 1997). The SDQ is divided between 5 scales, including emotional symptoms, conduct problems, peer relationship problems, hyperactivity/ inattention and prosocial behaviour and takes approximately 3-5 minutes to complete. Caregivers will complete the parent version of the SDQ, which demonstrates strong psychometric properties, including adequate test–retest reliability and internal consistency (a= .80) (Stone et al., 2010).
Timepoint [14] 429104 0
Baseline measures will be taken prior to intervention (T1), then immediately following 12 weeks of intervention (T2) then 3 months later (T3 - 6 months post baseline) and 9 months later (T4 - 12 months post baseline)
Secondary outcome [15] 429105 0
The Strengths and Difficulties Questionnaire [SDQ] is a 25-item behavioural screening questionnaire for young people aged 2-17 (Goodman, 1997). The SDQ is divided between 5 scales, including emotional symptoms, conduct problems, peer relationship problems, hyperactivity/ inattention and prosocial behaviour and takes approximately 3-5 minutes to complete. Caregivers will complete the parent version of the SDQ, which demonstrates strong psychometric properties, including adequate test–retest reliability and internal consistency (a= .80) (Stone et al., 2010).
Timepoint [15] 429105 0
Baseline measures will be taken prior to intervention (T1), then immediately following 12 weeks of intervention (T2) then 3 months later (T3 - 6 months post baseline) and 9 months later (T4 - 12 months post baseline)

Eligibility
Key inclusion criteria
Adolescents will be included if:
• they have a diagnosis of CP or ABI (at least 6 months post ABI);
• their caregiver reports they have difficulties with social competency;
• are motivated to develop friendships;
• attend mainstream high school;
• are between 11-17 years of age;
• have a verbal IQ > 70 measured on the Wechsler Abbreviated Scale of Intelligence 2nd Edition (WASI-II);
• they and their caregiver have basic proficiency in English;
• they and their caregiver are able to commit to the pre and post assessments, 14 weekly sessions AND complete homework tasks;
• their caregiver return the intake forms within the time frame suggested.
Minimum age
11 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria of this study were developed to accommodate all participants in a safe and ethical manner. Youth will be excluded if: they have uncontrolled epilepsy; severe visual or auditory impairment or are non-verbal.

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)
consecutively numbered sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated random number sequence with concealed allocation will be used for allocation. Sequence generation by biostatistician not involved in the study.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
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 Canadian Occupational Performance Measure (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.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2023
Actual
1/06/2023
Date of last participant enrolment
Anticipated
31/03/2024
Actual
Date of last data collection
Anticipated
30/09/2025
Actual
Sample size
Target
32
Accrual to date
15
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 23780 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 39227 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 312080 0
Government body
Name [1] 312080 0
National Injury Insurance Scheme Queensland
Country [1] 312080 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Child Health Research Centre, The University of Queensland
62 Graham Street,
South Brisbane QLD 4101
Country
Australia
Secondary sponsor category [1] 313595 0
None
Name [1] 313595 0
Address [1] 313595 0
Country [1] 313595 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311488 0
Children's Health Queensland Human Research Ethics Committee
Ethics committee address [1] 311488 0
Children's Health Queensland Human Research Ethics Committee
Centre for Children's Health Research
Queensland CHildren's Hospital Precinct
Level 7
62 Graham Street
South Brisbane QLD 4101
Ethics committee country [1] 311488 0
Australia
Date submitted for ethics approval [1] 311488 0
29/08/2022
Approval date [1] 311488 0
12/10/2022
Ethics approval number [1] 311488 0
HREC/2022/QCHQ/89593
Ethics committee name [2] 312206 0
University of Queensland Research Ethics and Integrity
Ethics committee address [2] 312206 0
University of Queensland
Brisbane Q 4072
Ethics committee country [2] 312206 0
Australia
Date submitted for ethics approval [2] 312206 0
13/10/2022
Approval date [2] 312206 0
14/10/2022
Ethics approval number [2] 312206 0
2022/HE002035

Summary
Brief summary
This mixed methods RCT of telehealth PEERS® for teens aims to test the effectiveness, acceptability and feasibility of a telehealth group delivered Program for the Education and Enrichment of Relational Skills (PEERS®) for high-school aged teenagers aged 11–17 years with acquired brain injury (ABI) or cerebral palsy (CP). In this pilot randomised controlled trial, we will recruit 32 teenagers with brain injuries and their caregiver across Queensland and randomise them to receive telehealth PEERS® or be waitlisted for 6 months. Telehealth PEERS® for teens will be run for groups of 8 youths and their caregivers. Four groups will be run over a two-year period in order to deliver the program to the immediate groups and control groups after the waitlist period. Outcomes will be measured before the intervention, after the telehealth PEERS® for teens program, and then 3 months later (6 months post baseline) and 9 months later (12 months post baseline). Focus groups using semi-structured interviews will be conducted separately with teens and caregivers at the end of the program to explore experiences of participation in telehealth PEERS® for teens.

Compared to care as usual, adolescents receiving PEERS® will achieve significantly greater gains in:
(i) self-perceived performance of social participation goals immediately post intervention (14 weeks) on the Canadian Occupational Performance Measure (COPM) of 2 points or greater.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121278 0
A/Prof Dr Leanne Sakzewski
Address 121278 0
Queensland Cerebral Palsy and Rehabilitation Research Centre
Centre for Children's Health Research
62 Graham Street
South Brisbane QLD 4101
Country 121278 0
Australia
Phone 121278 0
+61 7 30697345
Fax 121278 0
Email 121278 0
l.sakzewski1@uq.edu.au
Contact person for public queries
Name 121279 0
A/Prof Dr Leanne Sakzewski
Address 121279 0
Queensland Cerebral Palsy and Rehabilitation Research Centre
Centre for Children's Health Research
62 Graham Street
South Brisbane QLD 4101
Country 121279 0
Australia
Phone 121279 0
+61 7 30697345
Fax 121279 0
Email 121279 0
l.sakzewski1@uq.edu.au
Contact person for scientific queries
Name 121280 0
A/Prof Dr Leanne Sakzewski
Address 121280 0
Queensland Cerebral Palsy and Rehabilitation Research Centre
Centre for Children's Health Research
62 Graham Street
South Brisbane QLD 4101
Country 121280 0
Australia
Phone 121280 0
+61 7 30697345
Fax 121280 0
Email 121280 0
l.sakzewski1@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The study team are available to collaborate with other research teams upon receipt of a reasonable request to access study data. Expressions of interest to access study data (all of the individual participant data collected during the trial), made out the Principal Investigator, Assoc. Prof. Leanne Sakzewski will be considered and the group level or individual level de-identi data could be shared as appropriate.
When will data be available (start and end dates)?
Data will be available on completion of Data collection - 30/11/2025. End date: 2030
Available to whom?
The study team are available to collaborate with other research teams upon receipt of a reasonable request to access study data.
Available for what types of analyses?
Expressions of interest to access study data, made out the Principal Investigator, Assoc. Prof. Leanne Sakzewski will be considered and the group level or individual level de-identified data could be shared as appropriate for IPD met-analyses.
How or where can data be obtained?
Expressions of interest to access study data, made out the Principal Investigator, Assoc. Prof. Leanne Sakzewski will be considered. Postal Address: Assoc. Prof. Leanne Sakzewski
UQ - Queensland Cerebral Palsy and Rehabilitation Research Centre (QCPRRC) Centre for Children’s Health Research Level 6, 62 Graham Street, South Brisbane Qld 4101 Australia E: l.sakzewski1@uq.edu.au


What supporting documents are/will be available?




Results publications and other study-related documents

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