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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pilot trial of the Fear-Less Triple P 1/2 day workshop with parents of children in Disability Services.
Scientific title
Evaluating the feasibility of the Fear-Less Triple P 1/2 day workshop with parents of anxious children engaged with Disability Services.
Secondary ID [1] 293406 0
Universal Trial Number (UTN)
Trial acronym
Fear-Less in Disability Services
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 305557 0
Intellectual and/or physical disability 305558 0
Condition category
Condition code
Mental Health 304783 304783 0 0
Mental Health 304784 304784 0 0
Other mental health disorders

Study type
Description of intervention(s) / exposure
The Fear-less Triple P 1/2 day workshop consists of one 4-hour workshop that will be held at each of the three Disability Services centres (Nundah, Oxley and Mt. Gravatt) in Brisbane. Up to 12 families will be included in each workshop. The content covered in the workshop includes: psychoeducation about anxiety; promoting emotional resilience in children; the role of thoughts in anxiety and how to encourage mental flexibility; the role of avoidance in anxiety and exposure; parental responses to children's anxiety (and the advantages and disadvantages of each of these); constructive coping and maintaining gains over time.
All sessions will be conducted by the named investigator - an experienced Clinical Psychologist.
The workshop is attended by parents only. Ideally, both parents/caregivers would attend; but it is more likely that one parent will attend the workshop per family.
Treatment adherence will be assessed by a postgraduate trainee completing their Masters or Doctorate in Clinical Psychology. This person will attend the workshop in an observational capacity and use a checklist to record whether the content that is meant to be presented was actually presented.

Intervention code [1] 299650 0
Treatment: Other
Intervention code [2] 299703 0
Comparator / control treatment
This trial will make use of a wait list control group (one of the three service centres). In this service centre, parents will complete a 'pre-intervention' assessment. Approximately 3 months later, they will complete the same assessment. Once they have completed this 'post-wait' assessment, these parents will be offered the workshop intervention (between 3-4 months after their initial pre-intervention assessment).
Control group

Primary outcome [1] 304002 0
Parent report on the Spence Children's Anxiety Scale (SCAS)
Timepoint [1] 304002 0
3-month follow-up (i.e., 3-months post-workshop) and 6-month follow-up (i.e., 6-months post-workshop).
Secondary outcome [1] 340698 0
Clinical severity ratings (CSRs) of anxiety diagnoses met on the parent version of the Anxiety Disorders INterview Schedule for Children (ADIS-C).
Timepoint [1] 340698 0
3-month follow-up (i.e., 3-months post-workshop) and 6-month follow-up (ie., 6-months post-workshop)

Key inclusion criteria
Parents/caregivers must have a child aged 6-16 years who is currently anxious and engaged with Disability Services (Department of Communities, Child Safety and Disability Services). There is no restriction on parent/caregiver age.
Minimum age
6 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Participants will be excluded if psychological assistance is currently being sought for the child's anxiety.

Study design
Purpose of the study
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will not be concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people assessing the outcomes
Intervention assignment
Other design features
Disability Services in Brisbane has 3 Service Centres: Nundah, Oxley and Mt. Gravatt. Families at two of the three Service Centres will receive the intervention within approximately one fortnight of completing their pre-intervention assessment. Families from the third Service Centre will complete a second pre-intervention assessment approximately 3 months after completing the first pre-intervention assessment. This will effectively serve as a 'post-wait' assessment, with these families constituting a naturalistic wait list control group. They will receive the intervention once they have completed their second 'pre-intervention' assessment - so approximately 3.5 months after being initially assessed.
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
It is not an inclusion criteria that children meet diagnostic criteria for an anxiety diagnosis - merely that their parents/caregivers identify that their children experience anxiety. Thus, although diagnostic status will be examined, it is not the primary outcome.
The primary outcome (parent report of anxiety symptoms on the Spence Children's ANxiety Scale) will be analysed using repeated measures ANOVAs. Diagnostic status (where applicable) will be examined using chi-square analyses.

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 298028 0
Name [1] 298028 0
The University of Queensland
Address [1] 298028 0
School of Psychology
University of Queensland
St. Lucia, QLD, 4072.
Country [1] 298028 0
Primary sponsor type
The University of Queensland
School of Psychology
University of Queensland
St. Lucia, QLD, 4072.
Secondary sponsor category [1] 297104 0
Government body
Name [1] 297104 0
Department of Communities, Child Safety and Disability Services
Address [1] 297104 0
WorkLevel 1,
The Station Oxley
133 Oxley Station Road
Oxley Qld 4075
Country [1] 297104 0

Ethics approval
Ethics application status
Ethics committee name [1] 299060 0
The University of Queensland
Ethics committee address [1] 299060 0
The University of Queensland
St. Lucia, QLD, 4072.
Ethics committee country [1] 299060 0
Date submitted for ethics approval [1] 299060 0
Approval date [1] 299060 0
Ethics approval number [1] 299060 0

Brief summary
Anxiety is the most common psychological problem reported by children and adolescents. Among young people with a physical and/or intellectual disability, prevalence rates for clinically significant anxiety problems are significantly higher relative to the general population. With child-focused cognitive behavioural therapy (CBT) regarded as the gold-standard treatment for child anxiety, youth with disabilities often miss out on the evidence-based treatment of choice. Recent research has focused on the possibility of working through parents to address anxiety in children. The current project builds on this work with a population of families who are frequently under-served when it comes to the treatment of their children's anxiety.
The purpose of the proposed project is to evaluate the efficacy and acceptability of the half-day Fear-less Triple P workshop (involving parents only) in its capacity to reduce the anxiety symptoms of children with high levels of anxiety and a physical and/or intellectual disability. A naturalistic waitlist group will be built into the study design to allow comparison of this group with the active Fear-less workshop.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 79150 0
A/Prof Vanessa Cobham
Address 79150 0
School of Psychology
University of Queensland
St. Lucia, QLD, 4072.
Country 79150 0
Phone 79150 0
Fax 79150 0
Email 79150 0
Contact person for public queries
Name 79151 0
A/Prof Vanessa Cobham
Address 79151 0
School of Psychology
University of Queensland
St. Lucia, QLD, 4072.
Country 79151 0
Phone 79151 0
Fax 79151 0
Email 79151 0
Contact person for scientific queries
Name 79152 0
A/Prof Vanessa Cobham
Address 79152 0
School of Psychology
University of Queensland
St. Lucia, QLD, 4072.
Country 79152 0
Phone 79152 0
Fax 79152 0
Email 79152 0

No data has been provided for results reporting
Summary results
Not applicable