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Trial registered on ANZCTR


Registration number
ACTRN12618001609246p
Ethics application status
Submitted, not yet approved
Date submitted
25/09/2018
Date registered
27/09/2018
Date last updated
27/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the Fear-Less Triple P workshop with parents of anxious children who have hearing loss.
Scientific title
Evaluating the Fear-Less Triple P workshop with parents of anxious children who have hearing loss.
Secondary ID [1] 296172 0
None
Universal Trial Number (UTN)
U1111-1221-0078
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 309790 0
Hearing loss 309791 0
Condition category
Condition code
Mental Health 308583 308583 0 0
Anxiety
Ear 308584 308584 0 0
Deafness
Mental Health 308585 308585 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Fear-Less Triple P workshop consists of a one-day (8 hour) group-based workshop that will be held at Hear and Say site in Ashgrove, Brisbane. Up to 15 families will be included in a 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. Fear-Less Triple P provides parents/caregivers with the opportunity to learn through didactic presentation, demonstrations, discussion, role-plays and feedback.
The Fear-Less Triple P workshop will be conducted by the Primary 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.
The Fear-Less Triple P workshop will be video recorded so that a research assistant who is blind to participant allocation can review and confirm treatment adherence.
Intervention code [1] 312498 0
Treatment: Other
Intervention code [2] 312499 0
Behaviour
Comparator / control treatment
The trial will make use of a wait list control group. Parents of families assigned to the waitlist control group will complete a 'pre-intervention' assessment. Approximately three months later, they will complete the same assessment. Once they have completed this 'post-wait' assessment, these parents will be offered the Fear-Less Triple P workshop intervention (between 3-4 months after their initial pre-intervention assessment).
Control group
Active

Outcomes
Primary outcome [1] 307547 0
Parent report on the Spence Children's Anxiety Scale (SCAS)
Timepoint [1] 307547 0
3-month follow-up (i.e., 3-months post-workshop) and 6-month follow-up (i.e., 6-months post-workshop).
Primary timepoints = 3-month and 6-months.
Primary outcome [2] 307548 0
Child report on the Spence Children's Anxiety Scale (SCAS)
Timepoint [2] 307548 0
3-month follow-up (i.e., 3-months post-workshop) and 6-month follow-up (i.e., 6-months post-workshop).
Primary timepoints = 3-month and 6-months.
Secondary outcome [1] 352276 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] 352276 0
3-month follow-up (i.e., 3-months post-workshop) and 6-month follow-up (i.e., 6-months post-workshop)
Secondary outcome [2] 352277 0
Clinical severity ratings (CSRs) of anxiety diagnoses met on the child version of the Anxiety Disorders Interview Schedule for Children (ADIS-C)
Timepoint [2] 352277 0
3-month follow-up (i.e., 3-months post-workshop) and 6-month follow-up (i.e., 6-months post-workshop)

Eligibility
Key inclusion criteria
To be eligible to participate, one or both parents will be required to be concerned about their child’s anxiety, be able to attend a Fear-Less Triple P workshop, and undertake assessment procedures. The child of concern will be required to be aged between 7-12 years old, have hearing loss and be able to undertake assessment procedures. It is not required that the children meet the diagnostic criteria for an anxiety diagnosis. There is no restriction on parent/caregiver age.
Minimum age
7 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Families where the child of concern is currently receiving treatment (psychological or medication) for anxiety will be excluded from the study. Participants who cannot read, write or speak in English will also be excluded from the study.

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)
Allocation will not be concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised simple randomisation sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other
Other design features
Families randomised to the treatment group will receive the intervention within approximately one-fortnight of completing their pre-intervention assessment. Families randomised to the waitlist group 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 and child 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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 300764 0
University
Name [1] 300764 0
The University of Queensland
Country [1] 300764 0
Australia
Funding source category [2] 300765 0
Other Collaborative groups
Name [2] 300765 0
Hear and Say
Country [2] 300765 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] 300302 0
Other Collaborative groups
Name [1] 300302 0
Hear and Say
Address [1] 300302 0
29 Nathan Avenue, Ashgrove Qld 4060
Country [1] 300302 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 301545 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [1] 301545 0
Ethics committee country [1] 301545 0
Australia
Date submitted for ethics approval [1] 301545 0
30/07/2018
Approval date [1] 301545 0
Ethics approval number [1] 301545 0

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

Contacts
Principal investigator
Name 87342 0
A/Prof Vanessa Cobham
Address 87342 0
School of Psychology
University of Queensland
St. Lucia, QLD, 4072
Country 87342 0
Australia
Phone 87342 0
+61-7-33469911
Fax 87342 0
Email 87342 0
vanessa@psy.uq.edu.au
Contact person for public queries
Name 87343 0
Vanessa Cobham
Address 87343 0
School of Psychology
University of Queensland
St. Lucia, QLD, 4072
Country 87343 0
Australia
Phone 87343 0
+61-7-33469911
Fax 87343 0
Email 87343 0
vanessa@psy.uq.edu.au
Contact person for scientific queries
Name 87344 0
Vanessa Cobham
Address 87344 0
School of Psychology
University of Queensland
St. Lucia, QLD, 4072
Country 87344 0
Australia
Phone 87344 0
+61-7-33469911
Fax 87344 0
Email 87344 0
vanessa@psy.uq.edu.au

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

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