Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001625369
Ethics application status
Approved
Date submitted
20/11/2017
Date registered
13/12/2017
Date last updated
13/12/2017
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
None
Universal Trial Number (UTN)
U1111-1205-4538
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
Anxiety
Mental Health 304784 304784 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
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
Behaviour
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
Active

Outcomes
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)

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
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
Treatment
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)
N/A
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other
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.
Phase
Not Applicable
Type of endpoint/s
Efficacy
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
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
25/09/2017
Date of last participant enrolment
Anticipated
18/12/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 298028 0
University
Name [1] 298028 0
The University of Queensland
Country [1] 298028 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
School of Psychology
University of Queensland
St. Lucia, QLD, 4072.
Country
Australia
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
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299060 0
The University of Queensland
Ethics committee address [1] 299060 0
Ethics committee country [1] 299060 0
Australia
Date submitted for ethics approval [1] 299060 0
13/07/2017
Approval date [1] 299060 0
08/09/2017
Ethics approval number [1] 299060 0
17-PSYCH-MCP-36-JS

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

Contacts
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
Australia
Phone 79150 0
+61-7-33469911
Fax 79150 0
Email 79150 0
[email protected]
Contact person for public queries
Name 79151 0
Vanessa Cobham
Address 79151 0
School of Psychology
University of Queensland
St. Lucia, QLD, 4072.
Country 79151 0
Australia
Phone 79151 0
+61-7-33469911
Fax 79151 0
Email 79151 0
[email protected]
Contact person for scientific queries
Name 79152 0
Vanessa Cobham
Address 79152 0
School of Psychology
University of Queensland
St. Lucia, QLD, 4072.
Country 79152 0
Australia
Phone 79152 0
+61-7-33469911
Fax 79152 0
Email 79152 0
[email protected]

No information has been provided regarding IPD availability


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.