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Trial registered on ANZCTR


Registration number
ACTRN12623000911695
Ethics application status
Approved
Date submitted
9/08/2023
Date registered
25/08/2023
Date last updated
4/04/2024
Date data sharing statement initially provided
25/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of a Family Intervention for Children with Autism Spectrum Disorder (ASD) Who Are Bullied
Scientific title
Effectiveness of Resilience Triple P for Reducing Rates of Peer Victimisation in Children with ASD Who Are Bullied
Secondary ID [1] 310340 0
Nil known
Universal Trial Number (UTN)
U1111-1296-4222
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peer victimisation 331074 0
Autism Spectrum Disorder (ASD) 331075 0
Condition category
Condition code
Mental Health 327864 327864 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 327865 327865 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Families in the intervention group will be offered a place in an upcoming Resilience Triple P program. Resilience Triple P was developed for children who are bullied at school and their families. The program consists of 12 group sessions over eight weeks. There will be six to eight families in a program. Each session runs for up to 1 hour for children and up to 2 hours for parents, including a break. Eight sessions are for children (with parents attending) and these will be held weekly. In these sessions children learn strategies for strengthening their friendships and responding to bullying and conflict. The other four sessions are for parents and these will be held fortnightly. In parent sessions we look at ways to support their children’s friendships, coach effective responses to bullying and conflict, and work well with their children’s schools to encourage an effective response to issues. Interactive activities and short videos will be used to teach skills in sessions. Between session activities involve keeping a brief record of the number of incidents of bullying children experience at school and putting into practice strategies families choose from the sessions. It is preferable (but not necessary) for both parents to attend the sessions. If only one parent can attend, it is recommended that this be the parent who spends the most time with the child. Families will be mailed hardcopy workbooks ("Resilience Triple P parent’s workbook" and "Resilience Triple P children’s workbook") and providers will use powerpoint presentations to deliver the program. The workbooks and presentations were developed by the authors of Resilience Triple P (Sanders & Healy, 2018). During each Resilience Triple P session, facilitators will record attendance, adverse events, and obstacles. Facilitators will also complete a session checklist and reflect on what went well and any problems at the end of each session.

Resilience Triple P will be delivered via Telehealth by Miss Alexandra Johnstone and Dr Karyn Healy. Miss Johnstone is a provisional psychologist and has experience providing psychological services to children with neurodevelopmental disorders and mental health problems. Dr Healy is a registered psychologist and has extensive experience supporting children in preventing and addressing bullying, and resolving conflict.
Intervention code [1] 326742 0
Behaviour
Comparator / control treatment
Families in the control group will receive treatment as usual. Families in the control group will not be offered an opportunity to complete Resilience Triple P at any point. Instead, families in the control group will be offered an opportunity to participate in a seminar and individual follow-up session after they complete the follow-up assessment session. Participation in the seminar involves attending an hour and a half group session which summarises the parenting strategies from Resilience Triple P and a 30-minute individual session to discuss how parents will put these strategies into practice. Families in the control group will also be invited to complete Triple P Online after they complete the follow-up assessment session, which is an intensive parenting program that is evidence-based and free to access.
Control group
Active

Outcomes
Primary outcome [1] 335711 0
The student and parent and teacher versions of the Bullying Survey for ASD (Chen & Schwartz, 2012) will be used to measure rates of victimisation. We will change the timeframe from "this school year" to "past couple of months".
Timepoint [1] 335711 0
0 months (pre-intervention), 4 months (primary endpoint), and 9 months after randomisation.
Primary outcome [2] 335792 0
The Preschool Feelings Checklist (PFC) (Luby et al., 1999) will be used to measure parent reported symptoms of depression.
Timepoint [2] 335792 0
0 months (pre-intervention), 4 months (primary endpoint), and 9 months after randomisation.
Primary outcome [3] 335793 0
The parent version of the Nisonger Child Behavior Rating Form (NCBRF) (Aman et al., 1996) will be used to measure insecure/anxious behaviours. This will be assessed as a composite outcome.
Timepoint [3] 335793 0
0 months (pre-intervention), 4 months (primary endpoint), and 9 months after randomisation.
Secondary outcome [1] 425261 0
The parent version of the Nisonger Child Behavior Rating Form (NCBRF) (Aman et al., 1996) will be used to measure conduct problems. This will be assessed as a composite outcome. This is an additional primary outcome.
Timepoint [1] 425261 0
0 months (pre-intervention), 4 months (primary endpoint), and 9 months after randomisation.
Secondary outcome [2] 425262 0
The Revised Children’s Anxiety and Depression Scale (RCADS) (Chorpita et al., 2000) will be used to measure self-reported symptoms of major depressive disorder. This is an additional primary outcome.
Timepoint [2] 425262 0
0 months (pre-intervention), 4 months (primary endpoint), and 9 months after randomisation.
Secondary outcome [3] 425263 0
The School Non-Attendance Checklist (SNACK) (Heyne et al., 2019) and report cards will be used to tally the number of school days missed because the child refused. This is an additional primary outcome
Timepoint [3] 425263 0
0 months (pre-intervention), 4 months (primary endpoint), and 9 months after randomisation.
Secondary outcome [4] 425265 0
The parent version of the Parenting Self-Regulation Scales (PSRS) (Sanders et al., 2017) will be used to measure self-management, self-efficacy, personal agency, self-sufficiency, and problem solving. This will be assessed as a composite outcome.
Timepoint [4] 425265 0
0 months (pre-intervention), 4 months, and 9 months after randomisation.
Secondary outcome [5] 425266 0
The parent version of the Emotion Regulation and Social Skills Questionnaire (ERSSQ) (Beaumont & Sofronoff, 2008) will be used to measure emotion regulation and social skills. This will be assessed as a composite outcome.
Timepoint [5] 425266 0
0 months (pre-intervention), 4 months, and 9 months after randomisation.
Secondary outcome [6] 425268 0
Items 24 and 25 from the teacher version of the Preschool Social Behaviour Scale (Crick et al., 1997) will be used to measure peer acceptance.
Timepoint [6] 425268 0
0 months (pre-intervention), 4 months, and 9 months after randomisation.
Secondary outcome [7] 425269 0
The Facilitative Parenting Scale (Healy & Sanders, 2008) will be used to measure parenting supportive of children’s peer skills and relationships. This will be assessed as a composite outcome.
Timepoint [7] 425269 0
0 months (pre-intervention), 4 months, and 9 months after randomisation.
Secondary outcome [8] 425271 0
Questions from the Triple P Client Satisfaction Questionnaire (Triple P – Positive Parenting Program®) will be used to conduct a structured interview to gauge acceptability of Resilience Triple P and ways to improve the delivery for children with ASD. Miss Johnstone will conduct the interviews. Interviews will take approximately 15 minutes and be audio-recorded.
Timepoint [8] 425271 0
4 months after randomisation (for parents in the intervention group only).
Secondary outcome [9] 425272 0
Children will rate how helpful they found the program on a 4-point scale from “not at all” to “extremely” helpful and asked, “what could we do differently to make the program better?" to gauge acceptability of Resilience Triple P and ways to improve the delivery for children with ASD.
Timepoint [9] 425272 0
4 months after randomisation (for children in the intervention group only).
Secondary outcome [10] 425643 0
The student and parent and teacher versions of the Bullying Survey for ASD (Chen & Schwartz, 2012) will be used to measure rates of bullying. We will change the timeframe from "this school year" to "past couple of months".
Timepoint [10] 425643 0
0 months (pre-intervention), 4 months, and 9 months after randomisation.
Secondary outcome [11] 425644 0
The parent version of the Nisonger Child Behavior Rating Form (NCBRF) (Aman et al., 1996) will be used to measure overly sensitive behaviours. This is an additional primary outcome.
Timepoint [11] 425644 0
0 months (pre-intervention), 4 months (primary endpoint), and 9 months after randomisation.
Secondary outcome [12] 425645 0
The parent version of the Nisonger Child Behavior Rating Form (NCBRF) (Aman et al., 1996) will be used to measure self-isolated/ritualistic behaviours. This will be assessed as a composite outcome. This is an additional primary outcome.
Timepoint [12] 425645 0
0 months (pre-intervention), 4 months (primary endpoint), and 9 months after randomisation.
Secondary outcome [13] 425646 0
The parent version of the Nisonger Child Behavior Rating Form (NCBRF) (Aman et al., 1996) will be used to measure self-injury/ stereotypic behaviours. This will be assessed as a composite outcome. This is an additional primary outcome.
Timepoint [13] 425646 0
0 months (pre-intervention), 4 months (primary endpoint), and 9 months after randomisation.
Secondary outcome [14] 425647 0
The Revised Children’s Anxiety and Depression Scale (RCADS) (Chorpita et al., 2000) will be used to measure self-reported symptoms of social phobia. This is an additional primary outcome.
Timepoint [14] 425647 0
0 months (pre-intervention), 4 months (primary endpoint), and 9 months after randomisation.
Secondary outcome [15] 425648 0
The Revised Children’s Anxiety and Depression Scale (RCADS) (Chorpita et al., 2000) will be used to measure self-reported symptoms of separation anxiety disorder. This is an additional primary outcome.
Timepoint [15] 425648 0
0 months (pre-intervention), 4 months (primary endpoint), and 9 months after randomisation.
Secondary outcome [16] 425649 0
The Revised Children’s Anxiety and Depression Scale (RCADS) (Chorpita et al., 2000) will be used to measure self-reported symptoms of generalized anxiety disorder. This is an additional primary outcome.
Timepoint [16] 425649 0
0 months (pre-intervention), 4 months (primary endpoint), and 9 months after randomisation.

Eligibility
Key inclusion criteria
To be eligible to participate, parents need to report that their child has been diagnosed with ASD by a paediatrician or psychologist, is aged between 7 and 12 years, lives at home, attends a mainstream primary school in Australia, and has been bullied at school. Parents will need to verify that their children have experienced either ongoing bullying for at least the past month or a recurrent problem with being bullied for at least the past year. To be eligible to participate, families will also need to be able to access the internet through a computer that has a camera, microphone, and speakers.
Minimum age
7 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children's school principals or class teachers do not consent to participate in the research.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using coin-tossing. We will randomly allocate participants to the intervention group or control group in blocks of 16.
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
We will need to recruit 70 families. A sample size of 70 has been suggested to provide reliable estimations of population petametres in pilot studies (Teare et al., 2014).

Hierarchical linear modelling within the linear mixed models framework of SPSS will be used to compare changes in peer victimisation, mental health problems, and school refusal between children with ASD whose families participate in Resilience Triple P and those who receive treatment as usual, while controlling for pre-intervention expectancy (Peugh & Enders, 2005). Linear mixed models are generally more robust to violations of normality than other methods and efficiently handle missing data through the restricted maximum likelihood estimator (Field, 2009; West, 2009).

Series of regression analyses including the PROCESS add-on will be used to determine whether changes in child social skills, facilitative parenting, and parental self-regulation mediate the relationship between participation in Resilience Triple P and changes in peer victimisation, mental health problems, and school refusal (Baron & Kenny, 1986).

Linear mixed models will be used to determine whether levels of child social skills are associated with levels of facilitative parenting.

Thematic analysis will be used to determine the acceptability and identify how to enhance the delivery of Resilience Triple P for children with ASD.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2024
Actual
14/03/2024
Date of last participant enrolment
Anticipated
31/07/2024
Actual
Date of last data collection
Anticipated
31/05/2025
Actual
Sample size
Target
70
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,VIC

Funding & Sponsors
Funding source category [1] 314545 0
University
Name [1] 314545 0
The University of Queensland
Country [1] 314545 0
Australia
Primary sponsor type
Individual
Name
Miss Alexandra Johnstone
Address
The Parenting and Family Support Centre, 19/13 Upland Rd, St Lucia QLD 4067
Country
Australia
Secondary sponsor category [1] 316500 0
Individual
Name [1] 316500 0
Dr Karyn Healy
Address [1] 316500 0
The Parenting and Family Support Centre, 19/13 Upland Rd, St Lucia QLD 4067
Country [1] 316500 0
Australia
Secondary sponsor category [2] 316507 0
Individual
Name [2] 316507 0
Prof Matthew Sanders
Address [2] 316507 0
The Parenting and Family Support Centre, 19/13 Upland Rd, St Lucia QLD 4067
Country [2] 316507 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313585 0
University of Queensland Human Research Ethics Committee A
Ethics committee address [1] 313585 0
St Lucia QLD 4072
Ethics committee country [1] 313585 0
Australia
Date submitted for ethics approval [1] 313585 0
28/07/2023
Approval date [1] 313585 0
04/08/2023
Ethics approval number [1] 313585 0
2023/HE000151

Summary
Brief summary
We will conduct a randomised controlled trial to investigate the effectiveness and acceptability of Resilience Triple P for mainstream primary school students in Australia who have been diagnosed with ASD and are bullied by their peers. Resilience Triple P was developed for children who are bullied at school and their families and aims to enhance children’s emotional resilience and social problem-solving skills. We will recruit 70 families and inform eligible families' schools of their concerns about bullying. Half of the families will be randomly assigned to receiving Resilience Triple P immediately. The remaining families will be allocated to the treatment as usual control condition and offered an opportunity to complete a seminar and individual follow-up session after their final assessment session. Children, parents, and teachers will be asked to complete assessments at 0 months, 4 months, and 9 months. Children whose families participate in Resilience Triple P are expected to experience greater reductions in peer victimisation, mental health problems, and school refusal compared to those who receive treatment as usual. It is also expected families will be satisfied with the program and provide important insights into improving the delivery of programs to children with ASD.
Trial website
https://exp.psy.uq.edu.au/rtp4asd/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128646 0
Dr Karyn Healy
Address 128646 0
The Parenting and Family Support Centre, 19/13 Upland Road, St Lucia QLD 4067
Country 128646 0
Australia
Phone 128646 0
+61418 989 393
Fax 128646 0
Email 128646 0
k.healy@psy.uq.edu.au
Contact person for public queries
Name 128647 0
Miss Alexandra Johnstone
Address 128647 0
The Parenting and Family Support Centre, 19/13 Upland Road, St Lucia QLD 4067
Country 128647 0
Australia
Phone 128647 0
+61404 763 580
Fax 128647 0
Email 128647 0
alexandra.johnstone@uq.net.au
Contact person for scientific queries
Name 128648 0
Miss Alexandra Johnstone
Address 128648 0
The Parenting and Family Support Centre, 19/13 Upland Road, St Lucia QLD 4067
Country 128648 0
Australia
Phone 128648 0
+61404 763 580
Fax 128648 0
Email 128648 0
alexandra.johnstone@uq.net.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?
All non-identifiable data from participants who consented for their data to be used in any future research or shared with external researchers after receiving human research ethics approval will be made available.
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
Researchers at the Parenting and Family Support Centre (University of Queensland) and external researchers who receive human research ethics approval to use the data.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Data will be archived indefinitely in UQ eSpace. Once researchers have ethical approval to access the data, they can request access to the data by emailing the Parenting and Family Support Centre (pfsc@psy.uq.edu.au).


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.