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Trial registered on ANZCTR


Registration number
ACTRN12623000195651
Ethics application status
Approved
Date submitted
14/02/2023
Date registered
23/02/2023
Date last updated
8/09/2024
Date data sharing statement initially provided
23/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy, feasibility and acceptability of a dual treatment approach for anxious children who do not respond to first-line psychological treatment
Scientific title
Efficacy, feasibility and acceptability of a dual treatment approach for anxious children who do not respond to first-line psychological treatment
Secondary ID [1] 308859 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 328832 0
Condition category
Condition code
Mental Health 325832 325832 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A referral letter addressed to children's medical practitioner containing information about, and a recommendation for, the 2018 Royal Australian and New Zealand College of Psychiatrists (RANZCP) guidelines for selective serotonin reuptake inhibitor (SSRI) medication as the follow-up treatment for children with anxiety disorders who do not respond to cognitive behavioural therapy (CBT). This letter will be given to children's parent/guardian after completion of the CBT course once the treating clinician has assessed the child and determined them to be a 'non-responder' to CBT. Parents/guardians will be informed to make and attend an appointment with their child's current treatment medical practitioner within the following 3 weeks to give the medical practitioner the referral letter. Adherence to the intervention, as well as issues concerning feasibility or acceptability (e.g., if parents were unable to get an appointment with their medical practitioner within the 3 week time allocation; if they did not want their child to be prescribed medication), will be measured through questionnaires that will be given to parents at the end of the testing phase, which will be 12 weeks after the referral letter has been delivered to treating medical practitioners.
Intervention code [1] 325304 0
Treatment: Other
Comparator / control treatment
A referral letter addressed to children's medical practitioner recommending continued practice of learnt CBT skills (treatment as usual). This letter will be given to children's parent/guardian after completion of the CBT course once the treating clinician has assessed the child and determined them to be a 'non-responder' to CBT. Parents/guardians will be informed to make and attend an appointment with their child's current treatment medical practitioner within the following 3 weeks to give the medical practitioner the referral letter. Adherence to the comparator treatment, as well as issues concerning feasibility or acceptability (e.g., if parents were unable to get an appointment with their medical practitioner within the 3 week time allocation; if they were dissatisfied with the course of follow-up treatment recommended by the medical practitioner), will be measured through questionnaires that will be given to parents at the end of the testing phase, which will be 12 weeks after the referral letter has been delivered to treating medical practitioners.
Control group
Active

Outcomes
Primary outcome [1] 333861 0
Remission from all anxiety disorders according to online diagnostic interview "Youth Online Diagnostic Assessment" (YODA)
Timepoint [1] 333861 0
12 weeks after referral letter has been delivered to treating medical practitioners
Primary outcome [2] 333862 0
Any change in anxiety symptoms, assessed by parent report using Spence Children’s Anxiety Scale
Timepoint [2] 333862 0
12 weeks after referral letter has been delivered to treating medical practitioners
Primary outcome [3] 333863 0
Any change in life impairment from anxiety, assessed by parent report using Child Anxiety Life Interference Scale
Timepoint [3] 333863 0
12 weeks after referral letter has been delivered to treating medical practitioners
Secondary outcome [1] 418518 0
Family treatment acceptability, assessed using a study-specific questionnaire
Timepoint [1] 418518 0
12 weeks after referral letter has been delivered to treating medical practitioners
Secondary outcome [2] 418519 0
Family treatment satisfaction, assessed using a study-specific questionnaire
Timepoint [2] 418519 0
12 weeks after referral letter has been delivered to treating medical practitioners
Secondary outcome [3] 418529 0
Proportion of families who agree to participate in randomisation to medication, determined by an audit of study enrolment/withdrawal logs
Timepoint [3] 418529 0
An audit of study enrolment/withdrawal logs will be maintained throughout the duration of the project. However, final numbers will be determined 12 weeks after referral letter has been delivered to treating medical practitioners.
Secondary outcome [4] 418709 0
Proportion of randomised families who successfully access a medical practitioner, assessed using a study-specific questionnaire
Timepoint [4] 418709 0
12 weeks after referral letter has been delivered to treating medical practitioner
Secondary outcome [5] 418710 0
Time taken to access a prescribing medical practitioner, assessed using a study-specific questionnaire
Timepoint [5] 418710 0
12 weeks after referral letter has been delivered to treating medical practitioners
Secondary outcome [6] 418711 0
Type of treatment that children were prescribed by their treating medical practitioner, assessed through parent-report using a study-specific questionnaire
Timepoint [6] 418711 0
12 weeks after referral letter has been delivered to treating medical practitioners
Secondary outcome [7] 418712 0
Adherence to any treatment prescribed by treating medical practitioners, assessed through parent-report using a study-specific questionnaire
Timepoint [7] 418712 0
12 weeks after referral letter has been delivered to treating medical practitioners
Secondary outcome [8] 418713 0
Any change in anxiety symptoms, assessed by child report using Spence Children’s Anxiety Scale
Timepoint [8] 418713 0
12 weeks after referral letter has been delivered to treating medical practitioners
Secondary outcome [9] 418714 0
Any change in life impairment from anxiety, assessed by child report using Child Anxiety Life Interference Scale
Timepoint [9] 418714 0
12 weeks after referral letter has been delivered to treating medical practitioners

Eligibility
Key inclusion criteria
Children with at least one anxiety disorder who attend a psychological program for the treatment of their anxiety disorder/s at the Macquarie University Centre for Emotional Health Clinic or the Griffith University Childhood Anxiety Disorders Clinic and who, after completion of the program, are assessed by a psychology clinician to still meet clinical criteria for an anxiety disorder.
Parents/guardians of these children will be asked to provide consent on behalf of their child and to provide information on primary and secondary outcomes. Any parents/guardians of children who meet inclusion criteria will be included.
Minimum age
7 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Already taking SSRI medication

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 involve contacting the holder of the allocation schedule who will be "off-site" from the clinics where participants will be allocated
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/04/2023
Actual
21/06/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
24
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD

Funding & Sponsors
Funding source category [1] 313080 0
Other Collaborative groups
Name [1] 313080 0
Growing Minds Australia
Country [1] 313080 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Balaclava Rd, Macquarie Park NSW 2109
Country
Australia
Secondary sponsor category [1] 314768 0
University
Name [1] 314768 0
Griffith University
Address [1] 314768 0
1 Parklands Dr, Southport QLD 4215
Country [1] 314768 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312326 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 312326 0
Balaclava Rd, Macquarie Park NSW 2109
Ethics committee country [1] 312326 0
Australia
Date submitted for ethics approval [1] 312326 0
10/02/2023
Approval date [1] 312326 0
13/04/2024
Ethics approval number [1] 312326 0
520231285448189
Ethics committee name [2] 316090 0
Griffith University Human Research Ethics Committee
Ethics committee address [2] 316090 0
https://www.griffith.edu.au/research/research-services/research-ethics-integrity/human/human-research-ethics-committee
Ethics committee country [2] 316090 0
Australia
Date submitted for ethics approval [2] 316090 0
31/05/2023
Approval date [2] 316090 0
13/06/2023
Ethics approval number [2] 316090 0
2023/381

Summary
Brief summary
Current psychological treatments for child anxiety are well-established and evaluated, yet up to half of children still have an anxiety disorder after treatment. According to guidelines by RANZCP, following unsuccessful treatment with a psychological program, children should be moved to a course of SSRI medication. While this sounds like a logical suggestion, it is currently not based on any scientific evaluation. The aim of this pilot study is to evaluate both the effectiveness of this approach and its implementation in the Australian community. Children aged 7-12 years who have current anxiety disorders will be treated with a scientifically tested psychological program in university services. Following this, children who still have a diagnosable anxiety disorder will be randomly allocated to either treatment as usual (continued practice of learned skills) or will receive a referral with detailed information recommending SSRI treatment to their current medical practitioner. Improvements in diagnoses, anxiety symptoms and life impairment will be assessed 15 weeks later, along with feasibility, acceptability and other implementation data such as how many medical practitioners agree to prescribe.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124262 0
Prof Ron Rapee
Address 124262 0
Level 3, Australian Hearing Hub, 16 University Ave, Macquarie University NSW 2109
Country 124262 0
Australia
Phone 124262 0
+61 2 9850 8032
Fax 124262 0
Email 124262 0
[email protected]
Contact person for public queries
Name 124263 0
Ron Rapee
Address 124263 0
Level 3, Australian Hearing Hub, 16 University Ave, Macquarie University NSW 2109
Country 124263 0
Australia
Phone 124263 0
+61 2 9850 8032
Fax 124263 0
Email 124263 0
[email protected]
Contact person for scientific queries
Name 124264 0
Ron Rapee
Address 124264 0
Level 3, Australian Hearing Hub, 16 University Ave, Macquarie University NSW 2109
Country 124264 0
Australia
Phone 124264 0
+61 2 9850 8032
Fax 124264 0
Email 124264 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.