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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

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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

acquired brain injury

cerebral palsy

Condition category

Condition code

Physical Medicine / Rehabilitation

Occupational therapy

Physical Medicine / Rehabilitation

Speech therapy

Neurological

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]

Treatment: Other

Intervention code [2]

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]

Social Skills Improvement System (SSIS) Rating Scales student self report

Timepoint [1]

Immediately post intervention (14 weeks)

Primary outcome [2]

Social Skills Improvement System (SSIS) Rating Scales parent report

Timepoint [2]

Immediately post intervention (14 weeks)

Secondary outcome [1]

Quality of Socialization Questionnaire (QSQ) student version

Timepoint [1]

Immediately post intervention (14 weeks )
26 weeks

Secondary outcome [2]

Quality of Socialization Questionnaire (QSQ) parent version

Timepoint [2]

Immediately post intervention (14 weeks)
26 weeks

Secondary outcome [3]

Social Responsiveness Scale

Timepoint [3]

14 weeks
26 weeks

Secondary outcome [4]

Test of Adolescent Social Skills Knowledge (TASSK).

Timepoint [4]

14 weeks
26 weeks

Secondary outcome [5]

Social Skills Improvement System (SSIS) Rating Scales student self report

Timepoint [5]

26 weeks

Secondary outcome [6]

Social Skills Improvement System (SSIS) Rating Scales parent self report

Timepoint [6]

26 weeks

Secondary outcome [7]

Combined parent and student reported acceptability and feasibility of PEERS through thematic analysis of semi-structured qualitative interview

Timepoint [7]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,QLD

Recruitment hospital [1]

Lady Cilento Children's Hospital - South Brisbane

Recruitment hospital [2]

The Children's Hospital at Westmead - Westmead

Recruitment postcode(s) [1]

4101 - South Brisbane

Recruitment postcode(s) [2]

2145 - Westmead

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Motor Accident Insurance Commission

Address [1]

Level 26, 1 William Street
GPO Box 2203
BRISBANE QLD 4001 Australia

Country [1]

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]

Hospital

Name [1]

Queensland Choildren's Hospital

Address [1]

Stanley Street
South Brisbane QLD 4101

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Children's Health Queensland Hospital and Health Service Human Research Ethics Committee (HREC)

Ethics committee address [1]

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]

Australia

Date submitted for ethics approval [1]

26/04/2017

Approval date [1]

22/05/2017

Ethics approval number [1]

Ethics committee name [2]

Cerebral Palsy Alliance Human Research Ethics Committee

Ethics committee address [2]

187 Allambie Rd, Allambie Heights, NSW 2100
 PO Box 6427, Frenchs Forest, NSW 2086

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

21/08/2017

Approval date [2]

16/11/2017

Ethics approval number [2]

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

Dr Leanne Sakzewski

Address

Queensland Cerebral Palsy and Rehabilitation Research Centre
Centre for Children's Health Research
Graham St
South Brisbane QLD 4101

Country

Australia

Phone

+61 7 30697345

Fax

[email protected]

Contact person for public queries

Name

Leanne Sakzewski

Address

Queensland Cerebral Palsy and Rehabilitation Research Centre
Centre for Children's Health Research
Graham St
South Brisbane QLD 4101

Country

Australia

Phone

+61 7 30697345

Fax

[email protected]

Contact person for scientific queries

Name

Leanne Sakzewski

Address

Queensland Cerebral Palsy and Rehabilitation Research Centre
Centre for Children's Health Research
Graham St
South Brisbane QLD 4101

Country

Australia

Phone

+61 7 30697345

Fax

[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.	Type	Citation	Link	Email	Other Details
6657	Study protocol	Gilmore 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
6658	Informed consent form			[email protected]
6659	Ethical approval			[email protected]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Multicentre, randomised waitlist control trial investigating a parent-assisted social skills group programme for adolescents with brain injuries: Protocol for the friends project.	2019	https://dx.doi.org/10.1136/bmjopen-2019-029587
Embase	Program for the Education and Enrichment of Relational Skills for adolescents with an acquired brain injury: A randomized controlled trial.	2022	https://dx.doi.org/10.1111/dmcn.15144

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically