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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]

None

Universal Trial Number (UTN)

U1111-1176-5909

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Anxiety disorders

Condition category

Condition code

Mental Health

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]

Treatment: Other

Comparator / control treatment

Standard Fear-less Triple P (i.e., the 6-session program).

Control group

Active

Outcomes

Primary outcome [1]

% of children free of their primary anxiety diagnosis, as measured on the Anxiety Disorders Interview Schedule for Children.

Timepoint [1]

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]

Scores on the Spence Children's Anxiety Scale, which will be completed by both parents and children.

Timepoint [1]

Secondary outcome [2]

Scores on the Parenting an Anxious Child questionnaire.

Timepoint [2]

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?

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

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment postcode(s) [1]

4072 - University Of Queensland

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Queensland

Address [1]

School of Psychology
University of Queensland
St. Lucia, QLD, 4072.

Country [1]

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]

Individual

Name [1]

Matthew Sanders

Address [1]

School of Psychology
University of Queensland
St. Lucia, QLD, 4072.

Country [1]

Australia

Secondary sponsor category [2]

Individual

Name [2]

Thomas Ollendick

Address [2]

Department of Psychology
Virginia Tech
460 Turner Street
Blacksburg, Virginia 24061-0355,

Country [2]

United States of America

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Behavioural and Social Sciences Ethical Review Committee, University of Queensland

Ethics committee address [1]

University of Queensland
St. Lucia, QLD, 4072.

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

06/06/2015

Approval date [1]

09/06/2015

Ethics approval number [1]

2014001727

Summary

Brief summary

This study aims to compare the efficacy of two different versions of Fear-less Triple P, a program for parents of anxiety-disordered children. The two versions differ in terms of intensity. The first version is the standard 6-session Fear-less program. The second version includes content from the 6-session Fear-less program but is delivered as a 6-hour workshop.

Trial website

https://exp.psy.uq.edu.au/fearless/about

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Vanessa Cobham

Address

School of Psychology
University of Queensland
St. Lucia, 4072, QLD.

Country

Australia

Phone

+61 7 33469911

Fax

[email protected]

Contact person for public queries

Name

Vanessa Cobham

Address

School of Psychology
University of Queensland
St. Lucia, 4072, QLD.

Country

Australia

Phone

+61 7 33469911

Fax

[email protected]

Contact person for scientific queries

Name

Vanessa Cobham

Address

School of Psychology
University of Queensland
St. Lucia, 4072, QLD.

Country

Australia

Phone

+61 7 33469911

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

All de-identified data will be available to be shared.

When will data be available (start and end dates)?

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.

Available to whom?

Data will be made available to research colleagues as appropriate.

Available for what types of analyses?

Meta-analyses.

How or where can data be obtained?

Upon request to the author. Email address is [email protected]

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
13224	Informed consent form			[email protected]
13225	Ethical approval			[email protected]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Piloting a one-day parent-only intervention in the treatment of youth with anxiety disorders: child and family-level outcomes.	2024	https://dx.doi.org/10.1186/s13034-023-00702-y

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically