Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000723381
Ethics application status
Approved
Date submitted
10/05/2017
Date registered
18/05/2017
Date last updated
30/01/2020
Date data sharing statement initially provided
5/02/2019
Date results information initially provided
5/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Friends Project: A randomised trial of the Program for the Education and Enrichment of Relational Skills (PEERS) for teenagers with acquired brain injury and cerebral palsy.
Scientific title
The Friends Project: A randomised trial of the Program for the Education and Enrichment of Relational Skills (PEERS) for teenagers with acquired brain injury and cerebral palsy.
Secondary ID [1] 291889 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acquired brain injury 303179 0
cerebral palsy 303180 0
Condition category
Condition code
Physical Medicine / Rehabilitation 302622 302622 0 0
Occupational therapy
Physical Medicine / Rehabilitation 302623 302623 0 0
Speech therapy
Neurological 302673 302673 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Program for the Education and Enrichment of Relational Skills (PEERS) (R) is a commercially available manualised intervention that uses a small group format of 8-10 teenagers. It comprises didactic instruction, parent-assistance (social coaching), role-playing and modeling, perspective taking questions, behavioural rehearsal, social coaching and in vivo homework assignments. The program comprises once per week 90 minute sessions for 14 weeks. The structure of each 90 minute teen session includes homework review (30 mins), didactic lesson using role play/exercise (30 mins), socialization activity (20 mins); reunification with parents (10 mins). Concurrent 90 minute parent sessions consist of homework review (60 mins), review of adolescent didactic lesson (10 mins); homework assignment (10 mins); reunification with teens (10 mins). The parent program covers the same topics as the teenage group.
The program content includes:
Session 1: Introduction and conversational skills I – Trading Information
Session 2: Conversational Skills II – two way conversations
Session 3: Conversational Skills III – electronic communication (voicemail, email, text messaging, social networking, online safety);
Session 4: Choosing appropriate friends (identifying a peer group/crowd, identifying extracurricular activities)
Session 5: Appropriate use of humour (e.g. paying attention to humour feedback)
Session 6: Peer Entry I – entering a conversation (starting and entering conversations with potential friends);
Session 7: Peer Entry II – exiting a conversation
Session 8: Get togethers
Session 9 : Good sportsmanship (being a good host or guest during get-togethers);
Session 10: Rejection 1 – teasing and embarrassing feedback (handling teasing, physical bullying, managing rumours and gossip, minimizing cyber bullying, changing a bad reputation);
Session 11: Rejection II – Bullying and bad reputations
Session 12: Handling disagreements
Session 13: Rumours and gossip
Session 14: Graduation and termination (final review, graduation party and ceremony).
Weekly homework tasks will take approximately 30 minutes for teenagers and parents to arrange and carry out, depending on the week of the program. An example is for a teenager to identify someone from the group to call outside of group time and practise conversation skills with them. The parent would be expected to support the teenager in identifying the person, arranging, monitoring success of the call and troubleshooting difficulties. Another example is to have a get together with a friend and practise being a good sport during board games or computer games. In this week, the teen also needs to practise handling teasing if the opportunity comes up at school. This week’s homework can take up to two hours considering that it involves a social get together which could be also viewed as a regular adolescent activity for a weekend.
The teen and parent sessions will be run by experienced occupational therapists, speech pathologists and psychologists. Sessions will be run at a community therapy centre or research centre depending on the site.
Fidelity monitoring: Fidelity monitoring will be conducted at each site by the research assistant who will be trained by the therapists to complete weekly fidelity checks, alternating between parent and teen groups. The checklist was developed specifically for the PEERS program to ensure that the main content points in the manual are delivered for each session and has been used in previous studies.
Intervention code [1] 298001 0
Treatment: Other
Intervention code [2] 298042 0
Behaviour
Comparator / control treatment
Waitlist control group receiving care as usual for 26 weeks and will then be offered PEERS
Control group
Active

Outcomes
Primary outcome [1] 302031 0
Social Skills Improvement System (SSIS) Rating Scales student self report
Timepoint [1] 302031 0
Immediately post intervention (14 weeks)
Primary outcome [2] 302032 0
Social Skills Improvement System (SSIS) Rating Scales parent report
Timepoint [2] 302032 0
Immediately post intervention (14 weeks)
Secondary outcome [1] 334567 0
Quality of Socialization Questionnaire (QSQ) student version
Timepoint [1] 334567 0
Immediately post intervention (14 weeks )
26 weeks
Secondary outcome [2] 334568 0
Quality of Socialization Questionnaire (QSQ) parent version
Timepoint [2] 334568 0
Immediately post intervention (14 weeks)
26 weeks
Secondary outcome [3] 334569 0
Social Responsiveness Scale
Timepoint [3] 334569 0
14 weeks
26 weeks
Secondary outcome [4] 334570 0
Test of Adolescent Social Skills Knowledge (TASSK).
Timepoint [4] 334570 0
14 weeks
26 weeks
Secondary outcome [5] 334651 0
Social Skills Improvement System (SSIS) Rating Scales student self report
Timepoint [5] 334651 0
26 weeks
Secondary outcome [6] 334683 0
Social Skills Improvement System (SSIS) Rating Scales parent self report
Timepoint [6] 334683 0
26 weeks
Secondary outcome [7] 334684 0
Combined parent and student reported acceptability and feasibility of PEERS through thematic analysis of semi-structured qualitative interview
Timepoint [7] 334684 0
26 weeks

Eligibility
Key inclusion criteria
(a) diagnosis of cerebral palsy or acquired brain injury (at least 12 months post ABI);
(b) are independently able to ambulate
(c) their parent reports they have difficulties with social competency;
(d) are motivated to develop friendships (determined through teen self-reporting during screening and intake procedures prior to commencement of group);
(e) attend mainstream high school
(f) are aged between 11-17 years;
(g) have a verbal IQ > 70 measured on the Wechsler Abbreviated Scale of Intelligence 2nd Edition (WASI-II);
(h) they and their parent have basic proficiency in English;
(i) they and their parent are able to commit to the pre and post assessments, 14 weekly sessions AND complete homework tasks;
(j) their parent return the intake forms within the time frame suggested.
Minimum age
11 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) have uncontrolled epilepsy
(b) severe visual or auditory impairment
(c) 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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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 audiotaped and transcribed. Transcripts will be thematically coded using Leximancer 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. The primary comparison H1 immediately post the intervention at 14 weeks will be based on the SSIS caregiver and child self-report on the domains of Social Skills, and Problem Behaviour and will be between treatment groups using generalized linear models. Secondary analyses will use similar methods to compare the outcomes between groups for secondary outcomes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2017
Actual
11/09/2017
Date of last participant enrolment
Anticipated
1/07/2018
Actual
5/02/2019
Date of last data collection
Anticipated
11/12/2019
Actual
11/12/2019
Sample size
Target
40
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 7977 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment hospital [2] 7978 0
The Children's Hospital at Westmead - Westmead
Recruitment postcode(s) [1] 15951 0
4101 - South Brisbane
Recruitment postcode(s) [2] 15952 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 296384 0
Government body
Name [1] 296384 0
Motor Accident Insurance Commission
Country [1] 296384 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Queensland Cerebral Palsy and Rehabilitation Research Centre
Centre for Children's Health Research
Graham St
South Brisbane QLD 4101
Country
Australia
Secondary sponsor category [1] 295359 0
Hospital
Name [1] 295359 0
Queensland Choildren's Hospital
Address [1] 295359 0
Stanley Street
South Brisbane QLD 4101
Country [1] 295359 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297622 0
The Children's Health Queensland Hospital and Health Service Human Research Ethics Committee (HREC)
Ethics committee address [1] 297622 0
Level 7, Centre for Children’s Health Research
Lady Cilento Children’s Hospital Precinct
62 Graham Street
South Brisbane QLD 4101
Ethics committee country [1] 297622 0
Australia
Date submitted for ethics approval [1] 297622 0
26/04/2017
Approval date [1] 297622 0
22/05/2017
Ethics approval number [1] 297622 0
Ethics committee name [2] 297640 0
Cerebral Palsy Alliance Human Research Ethics Committee
Ethics committee address [2] 297640 0
187 Allambie Rd, Allambie Heights, NSW 2100
PO Box 6427, Frenchs Forest, NSW 2086
Ethics committee country [2] 297640 0
Australia
Date submitted for ethics approval [2] 297640 0
21/08/2017
Approval date [2] 297640 0
16/11/2017
Ethics approval number [2] 297640 0

Summary
Brief summary
This parent-assisted social skills program (Program for the Education and Enrichment of Relational Skills: PEERS) aims to help teenagers develop the social skills needed to make and maintain friends. The program reduces the complexity of social behaviour and teaches simple rules, using modelling and practice. Parents participate in separate concurrent sessions to help them support their teenager with real world practice. The program has not been tested with teenagers with acquired brain injuries (ABI) and cerebral palsy (CP) . This study aims to pilot test PEERS for 40 youth with ABI and CP in a randomised waitlist controlled trial across two sites in Australia to improve social competence and friendships. Secondly, we will explore caregiver's and youth's experiences of participating in the PEERS program.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74622 0
Dr Leanne Sakzewski
Address 74622 0
Queensland Cerebral Palsy and Rehabilitation Research Centre
Centre for Children's Health Research
Graham St
South Brisbane QLD 4101
Country 74622 0
Australia
Phone 74622 0
+61 7 30697345
Fax 74622 0
Email 74622 0
[email protected]
Contact person for public queries
Name 74623 0
Dr Leanne Sakzewski
Address 74623 0
Queensland Cerebral Palsy and Rehabilitation Research Centre
Centre for Children's Health Research
Graham St
South Brisbane QLD 4101
Country 74623 0
Australia
Phone 74623 0
+61 7 30697345
Fax 74623 0
Email 74623 0
[email protected]
Contact person for scientific queries
Name 74624 0
Dr Leanne Sakzewski
Address 74624 0
Queensland Cerebral Palsy and Rehabilitation Research Centre
Centre for Children's Health Research
Graham St
South Brisbane QLD 4101
Country 74624 0
Australia
Phone 74624 0
+61 7 30697345
Fax 74624 0
Email 74624 0
[email protected]

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, made out to the Principal investigator, Dr Leanne Sakzewski, will be considered and then group level or individual level deidentified data could be shared as appropriate.
When will data be available (start and end dates)?
Data will be available on completion of data collection and data cleaning 31/12/2020
No end date determined.
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 to the Principal Investigator, Dr Leanne Sakzewski, will be considered and then group level or individual level deidentified data could be shared as appropriate
How or where can data be obtained?
Expressions of interest to access study data, made out to the Principal Investigator, Dr Leanne Sakzewski, will be considered
Postal address: The University of Queensland, Queensland Cerebral Palsy and Rehabilitation Research Centre, Centre for Children's Health Research, Level 6, 62 Graham Street, South Brisbane QLD 4101.
Email: [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6657Study protocolGilmore R, Sakzewski L, Ziviani J, McIntyre S, Smithers-Sheedy H, Hilton N, Williams T, Quinn K, Sarandrea AM, Laugeson E, Chatfield M. A multi-centre, randomised waitlist-control trial investigating a parent assisted social skills group programme for adolescents with brain injuries: The Friends Project. BMJ Open 2019, 9(8) e029587; https://bmjopen.bmj.com/content/9/8/e029587.long[email protected] Nil other
6658Informed consent form  [email protected]
6659Ethical approval  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseProgram for the Education and Enrichment of Relational Skills for adolescents with an acquired brain injury: A randomized controlled trial.2022https://dx.doi.org/10.1111/dmcn.15144
EmbaseMulticentre, randomised waitlist control trial investigating a parent-assisted social skills group programme for adolescents with brain injuries: Protocol for the friends project.2019https://dx.doi.org/10.1136/bmjopen-2019-029587
N.B. These documents automatically identified may not have been verified by the study sponsor.