Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12615001284550
Ethics application status
Approved
Date submitted
19/11/2015
Date registered
25/11/2015
Date last updated
16/09/2021
Date data sharing statement initially provided
16/09/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of delivering the Fear-less Triple P program at two differing levels of intensity for parents of children with anxiety disorders
Scientific title
Efficacy of delivering the Fear-less Triple P program at two differing levels of intensity for parents of children with anxiety disorders
Secondary ID [1] 287908 0
None
Universal Trial Number (UTN)
U1111-1176-5909
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety disorders 296785 0
Condition category
Condition code
Mental Health 297019 297019 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two active interventions will be compared. They cover the same content but vary in terms of duration and delivery. The content covered across the two interventions 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 postgraduate Clinical Psychology trainees, with some sessions to be conducted in conjunction with the named investigator - an experienced Clinical Psychologist.
Standard Fear-less Triple P consists of 6 weekly 1.5 to 2-hour sessions to be conducted at the University of Queensland. These sessions will be conducted in groups of up to 6 parents.
Workshop Fear-less Triple P consists of 1 6-hour workshop that will be held on at the University of Queensland. Up to 20 families will be included in each workshop.
All therapy sessions will be recorded and a random 25% will be listened to by an independent research assistant to check for treatment adherence. A checklist outlining the content to be covered in each version of the program (workshop and standard) will be used for ensuring treatment adherence.
Intervention code [1] 293264 0
Treatment: Other
Comparator / control treatment
Standard Fear-less Triple P (i.e., the 6-session program).
Control group
Active

Outcomes
Primary outcome [1] 296617 0
% of children free of their primary anxiety diagnosis, as measured on the Anxiety Disorders Interview Schedule for Children.
Timepoint [1] 296617 0
Post-treatment (1 week following completing of either the workshop or the 6-session standard program); 6-month follow-up (6 months post-completion); and 12-month follow-up (12 months post-completion). This change was made prior to any participants commencing in either treatment condition.
Secondary outcome [1] 318932 0
Scores on the Spence Children's Anxiety Scale, which will be completed by both parents and children.
Timepoint [1] 318932 0
Post-treatment (1 week following completing of either the workshop or the 6-session standard program); 6-month follow-up (6 months post-completion); and 12-month follow-up (12 months post-completion). This change was made prior to any participants commencing in either treatment condition.
Secondary outcome [2] 318933 0
Scores on the Parenting an Anxious Child questionnaire.
Timepoint [2] 318933 0
Post-treatment (1 week following completing of either the workshop or the 6-session standard program); 6-month follow-up (6 months post-completion); and 12-month follow-up (12 months post-completion). This change was made prior to any participants commencing in either treatment condition.

Eligibility
Key inclusion criteria
Child aged 7-14 years of age, meeting criteria for at least one clinically significant anxiety disorder (defined as meeting criteria for an anxiety disorder on the Anxiety Disorders Interview Schedule for Children, with a clinical severity rating of at least 4 out of 8).
The only inclusion criteria for parents was that they be able to speak English. Parent age was not seen as relevant.
Minimum age
7 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children who are receiving psychological intervention for their anxiety currently or who are taking medication for their anxiety currently.

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)
Central randomization by computer program.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
On the basis of the literature, it is expected that the % of children who recover from their primary anxiety diagnosis in both the standard and workshop versions of Fear-less Triple P will be equivalent from the 6-month follow-up point onwards. The study is planned to be powered to provide 85% power at the 5% (2-sided) significance level. The sample size required using G*Power is 52 families per group. Allowing for 20% loss to follow-up, it is planned to enrol 125 families in the trial.
Primary outcomes (diagnostic status) will be examined using chi square analyses. Secondary outcomes (questionnaire data) will be examined using repeated measures ANOVAs.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/09/2015
Date of last participant enrolment
Anticipated
30/03/2018
Actual
14/07/2017
Date of last data collection
Anticipated
27/07/2018
Actual
3/08/2018
Sample size
Target
125
Accrual to date
Final
75
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 12224 0
4072 - University Of Queensland

Funding & Sponsors
Funding source category [1] 292397 0
University
Name [1] 292397 0
University of Queensland
Country [1] 292397 0
Australia
Primary sponsor type
Individual
Name
Vanessa Cobham
Address
School of Psychology
University of Queensland
St. Lucia, QLD, 4072.
Country
Australia
Secondary sponsor category [1] 291107 0
Individual
Name [1] 291107 0
Matthew Sanders
Address [1] 291107 0
School of Psychology University of Queensland St. Lucia, QLD, 4072.
Country [1] 291107 0
Australia
Secondary sponsor category [2] 291108 0
Individual
Name [2] 291108 0
Thomas Ollendick
Address [2] 291108 0
Department of Psychology Virginia Tech 460 Turner Street Blacksburg, Virginia 24061-0355,
Country [2] 291108 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293881 0
Behavioural and Social Sciences Ethical Review Committee, University of Queensland
Ethics committee address [1] 293881 0
Ethics committee country [1] 293881 0
Australia
Date submitted for ethics approval [1] 293881 0
06/06/2015
Approval date [1] 293881 0
09/06/2015
Ethics approval number [1] 293881 0
2014001727

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

Contacts
Principal investigator
Name 61574 0
Dr Vanessa Cobham
Address 61574 0
School of Psychology University of Queensland St. Lucia, 4072, QLD.
Country 61574 0
Australia
Phone 61574 0
+61 7 33469911
Fax 61574 0
Email 61574 0
[email protected]
Contact person for public queries
Name 61575 0
Vanessa Cobham
Address 61575 0
School of Psychology University of Queensland St. Lucia, 4072, QLD.
Country 61575 0
Australia
Phone 61575 0
+61 7 33469911
Fax 61575 0
Email 61575 0
[email protected]
Contact person for scientific queries
Name 61576 0
Vanessa Cobham
Address 61576 0
School of Psychology University of Queensland St. Lucia, 4072, QLD.
Country 61576 0
Australia
Phone 61576 0
+61 7 33469911
Fax 61576 0
Email 61576 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Data will be made available to research colleagues as appropriate.

Conditions for requesting access:
• -

What individual participant data might be shared?
• All de-identified data will be available to be shared.

What types of analyses could be done with individual participant data?
• Meta-analyses.

When can requests for individual participant data be made (start and end dates)?
From:
This paper is currently under review for publication. The data will be available for sharing once the paper has been accepted. We hope this will happen by 31 December 2021. Data will be stored for 7 years, so the likely end date for data sharing would be 31 December 2028.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Upon request to the author. Email address is [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13224Informed consent form  [email protected]
13225Ethical approval  [email protected]



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePiloting a one-day parent-only intervention in the treatment of youth with anxiety disorders: child and family-level outcomes.2024https://dx.doi.org/10.1186/s13034-023-00702-y
N.B. These documents automatically identified may not have been verified by the study sponsor.