Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000515695
Ethics application status
Approved
Date submitted
26/04/2023
Date registered
18/05/2023
Date last updated
26/11/2023
Date data sharing statement initially provided
18/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
PEERS® Plus: A mixed methods randomised trial of the Program for the Education
and Enrichment of Relational Skills (PEERS®) adapted for primary and early high
school children with acquired brain injury and cerebral palsy.
Scientific title
PEERS® Plus: A mixed methods randomised trial of the Program for the Education
and Enrichment of Relational Skills (PEERS®) adapted for primary and early high
school children with acquired brain injury and cerebral palsy.
Secondary ID [1] 307794 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acquired Brain Injury 327376 0
Cerebral Palsy 327377 0
Condition category
Condition code
Physical Medicine / Rehabilitation 324498 324498 0 0
Occupational therapy
Physical Medicine / Rehabilitation 324499 324499 0 0
Speech therapy
Neurological 324500 324500 0 0
Other neurological disorders
Injuries and Accidents 326852 326852 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Program for the Education and Enrichment of Relational Skills (PEERS® PLUS) for primary school aged children (8-13 years) is a face to face group delivered and parent assisted social skills program. The manualised program is delivered consecutively across 12 weeks.
Participants randomised to block 1 of PEERS® PLUS will commence their involvement in the intervention. PEERS® PLUS comprises 12 weekly sessions of 90-minute duration, delivered in face-to-face groups of up to 8 participants. A concurrent parent group will run in a separate room for the same duration. Group sessions will be held outside typical school hours (estimated 4 pm-5:30 pm).

All sessions will run consecutively across 12 weeks. However, in the event of a school or public holiday, sessions will be paused. Any sessions missed due to timetabling conflicts will be rescheduled. Participants will be made aware of session dates/times before commencing their participation in their allocated block. It should be noted the program will not run or extend into extended periods of school holidays, i.e., 6–8-week summer holidays. Participants opting to complete individual dyad sessions over school holiday timeframes will be permitted to, pending staff availability.

The content of the sessions will include: (a) facial expression, emotions and body language; (b) focusing attention and active listening; (c) trading information and using your voice; (d) two-way conversations; (e) choosing appropriate friends and humour; (f) entering and exiting a conversation; (g) entering and exiting a game; (h) get-togethers; (i) good sports; (j) handling disagreements and regulating emotions; (k) teasing and embarrassing feedback; (l) Optional: Online communications. Content will be delivered by means of didactic instruction, role-playing and modelling, perspective-taking questions, behavioural rehearsal, parent-assistance (social coaching), and allocation and review of homework tasks to support the transition of learnt skills to home and community environments. The use of sociodramatic and creative and performing arts-based activities will be embedded within the program to maximise engagement of motivation of a younger age group and allow for additional behavioural rehearsal and social coaching opportunities. All activities are easily adapted to meet the needs of participants' skill levels and preferences.

The content of caregiver sessions will include: (a) social coaching; (b) reflection opportunities; (c) group discussion opportunities reflecting on topics covered in primary school sessions and individual needs.

Two therapists will lead each group session:
• Two for the child group (i.e., Occupational therapist (OT), or a combination of OT/Speech Pathologist (SP)
• Two for the caregiver group (i.e., OTs, or a combination of OT/Social Worker (SW)).

Homework: Time spent on homework tasks will vary throughout the duration of the program dependant on the weekly topic and allocated task.
Examples:
o Session 4: Children will participate an in-group call (Facetime or Zoom) and reflect on their experience with their caregiver (approximately 20 mins in total)
o Session 9: Children will attend or host a get-together with a peer (up to 2 hrs in duration)


Note: Estimated duration of homework tasks is expected to take between 10 mins to 2hrs per week dependent on the allocated task.

Adherence to intervention will be monitored by weekly fidelity checks - eg. attendance at in-person sessions (yes/no), checklist completion of subject areas (yes/no), checklist completion of homework tasks (yes/no/partially completed)

Alongside group sessions, individual dyad sessions will be held at three-time points. Dyad sessions will occur via virtual meeting (or on-site). It is envisaged that dyad sessions will occur between 8 am-7 pm on weekdays at a time convenient to each dyad; dyads should allow approximately 1 hour for their involvement in each session. The first session will focus on collaborative goal setting of 2-3 social participation goals, and the remaining two will be offered around the mid and endpoint of the program. The specific timing of dyad sessions will be flexible and reflect the needs of each family. One or two OTs will be involved in completing dyad sessions.

Therapists who will deliver the intervention have completed certified training to deliver PEERS® PLUS in its original formats. All other therapists have extensive experience working with children and youth with brain injuries and their families in both clinical and research contexts.

Focus groups using semi-structured interviews will be conducted separately with children and caregivers at the end of the program to explore experiences of participation in PEERS® PLUS. 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. All participants in the trial will be invited to participate in the focus groups.
Intervention code [1] 324259 0
Treatment: Other
Intervention code [2] 324260 0
Behaviour
Comparator / control treatment
Waitlist control group receiving usual care for 26 weeks and then will be offered PEERS® PLUS. Usual care is highly variable and not standardised. It is expected that participants in the wait list 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] 332333 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 (Test retest reliability is high [ICC0.76-0.89] and the COPM is responsive to change).
Timepoint [1] 332333 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 [1] 413064 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. It has good internal consistency (Cronbach alpha >70). The child will complete the student version of the Kidscreen-27 and the results will be assessed independently.
Timepoint [1] 413064 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 [2] 413065 0
Quality of Play Questionnaire. The 19-item parent completed questionnaire measures the frequency and quality of children’s play during recent playdates on a 4-point Likert scale.
Timepoint [2] 413065 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 [3] 413066 0
The Personal Experiences Checklist (PECK): the child will complete a 32-item form looking at events (including bullying) occurring in the past month.
Timepoint [3] 413066 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 [4] 413067 0
Parent reported acceptability and feasibility of PEERS® via semi-structured interviews separately with caregivers to explore the lived experience of PEERS for primary. 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 [4] 413067 0
Immediately following 12 weeks of intervention (T2)
Secondary outcome [5] 421799 0
Child reported acceptability and feasibility of PEERS® via semi-structured interviews separately with participants to explore the lived experience of PEERS for primary. 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] 421799 0
Immediately following 12 weeks of intervention (T2)
Secondary outcome [6] 421800 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. It has good internal consistency (Cronbach alpha >70). The child’s primary caregiver will complete the parent version of the Kidscreen-27 and the results will be assessed independently.
Timepoint [6] 421800 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 [7] 421867 0
The Test of Child Social Skills Knowledge [TCSSK]. The TCSSK is an adapted version of the Test of Adolescent Social Skills Knowledge-Revised [TASSK-R and measures social knowledge. The 22-item self-report questionnaire will measure a child’s knowledge of the specific skills taught throughout the PEERS® PLUS program. The TCSSK takes approximately 5-10 minutes and requires participants to select the best option from two available answers. Total raw scores range from 0 to 22; a higher total score reflects higher knowledge of social skills. This change was made prior to recruitment commenced.
Timepoint [7] 421867 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] 421868 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 thh child's caregiver only.
Timepoint [8] 421868 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] 429108 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 [9] 429108 0
Secondary outcome [10] 429109 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] 429109 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] 429110 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 [11] 429110 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] 429111 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 [12] 429111 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
Children will be included if:
1. they have a diagnosis of CP or ABI (at least 6 months post ABI);
2. their caregiver reports they have difficulties with social competency;
3. are motivated to develop friendships;
4. attend mainstream school (Grades 3 and above) and are aged 8-13 years
5. have a verbal IQ > 70 measured on the Wechsler Abbreviated Scale of Intelligence 2nd Edition (WASI-II);
6. use speech understood by unfamiliar listeners
6. they and their caregiver have basic proficiency in English;
7. they and their caregiver are able to commit to the pre and post assessments, 12-13 weekly sessions (Note: Session 13 is optional) AND complete homework tasks;
8. their caregiver return the intake forms within the time frame suggested.
Minimum age
8 Years
Maximum age
13 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. Children will be excluded if:
1. they have uncontrolled epilepsy;
2. they have severe visual or auditory impairment
3. they 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)
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
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 a biostatistician not involved in the study.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
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 audiotapes and transcribed. Transcripts will be thematically coded using NVivo software.
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® PLUS) 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 12 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
14/08/2023
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
7
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 22982 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 38295 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 312064 0
Government body
Name [1] 312064 0
National Injury Insurance Scheme Queensland
Country [1] 312064 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Centre for Children's Health Research
62 Graham Street
South Brisbane 4101
Country
Australia
Secondary sponsor category [1] 313569 0
None
Name [1] 313569 0
Address [1] 313569 0
Country [1] 313569 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311474 0
Children's Health Queensland Human Research Ethics Committee
Ethics committee address [1] 311474 0
Ethics committee country [1] 311474 0
Australia
Date submitted for ethics approval [1] 311474 0
26/08/2022
Approval date [1] 311474 0
28/09/2022
Ethics approval number [1] 311474 0
HREC/22/QCHQ/87450

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

Contacts
Principal investigator
Name 121222 0
A/Prof Leanne Sakzewski
Address 121222 0
Queensland Cerebral Palsy and Rehabilitation Research Centre
Centre for Children's Health Research
62 Graham Street
South Brisbane QLD 4101
Country 121222 0
Australia
Phone 121222 0
+61 7 30697345
Fax 121222 0
Email 121222 0
l.sakzewski1@uq.edu.au
Contact person for public queries
Name 121223 0
Leanne Sakzewski
Address 121223 0
Queensland Cerebral Palsy and Rehabilitation Research Centre
Centre for Children's Health Research
62 Graham Street
South Brisbane QLD 4101
Country 121223 0
Australia
Phone 121223 0
+61 7 30697345
Fax 121223 0
Email 121223 0
l.sakzewski1@uq.edu.au
Contact person for scientific queries
Name 121224 0
Leanne Sakzewski
Address 121224 0
Queensland Cerebral Palsy and Rehabilitation Research Centre
Centre for Children's Health Research
62 Graham Street
South Brisbane QLD 4101
Country 121224 0
Australia
Phone 121224 0
+61 7 30697345
Fax 121224 0
Email 121224 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 - 30/09/2025 for 5 years.
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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17003Informed consent form    384541-(Uploaded-26-04-2023-10-43-11)-Study-related document.pdf
18130OtherStudy Flyer    Study Flyer 384541-(Uploaded-26-04-2023-10-42-44)-Study-related document.pdf



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.