Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000514505
Ethics application status
Approved
Date submitted
8/05/2015
Date registered
22/05/2015
Date last updated
8/12/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Preliminary evaluation of Fear-less Triple P for parents of anxiety-disordered children
Scientific title
A preliminary evaluation of Fear-less Triple P for parents of anxiety-disordered children: Examining children's anxiety symptomatology post-intervention.
Secondary ID [1] 286669 0
Nil known
Universal Trial Number (UTN)
U1111-1170-0134
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety disorders in children 295008 0
Condition category
Condition code
Mental Health 295272 295272 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Fear-less Triple P is a 6-session, weekly program for parents of anxiety-disordered children. Sessions are of 60-90 minutes duration, and are administered in small groups of 6-8 families. Administering clinicians include clinical psychologists and intern psychologists - students completing their postgraduate studies in clinical psychology. Content covered includes: Psychoeducation about anxiety; emotional resilience; cognitive challenging; exposure; strategies for managing children's anxiety; and problem solving. Sessions are recorded in order to be able to review for treatment adherence.
Intervention code [1] 291820 0
Treatment: Other
Intervention code [2] 291881 0
Behaviour
Comparator / control treatment
The active treatment condition (Fear-less Triple P) was compared to a Waitlist control condition, in which participants were assessed before and after a 6 week wait (the equivalent duration of the active treatment being evaluated).
Control group
Active

Outcomes
Primary outcome [1] 295018 0
Children's anxiety diagnosis status on the Anxiety Disorders Interview Schedule for Children (ADIS-C).
Timepoint [1] 295018 0
Post-treatment; 3-month, 6-month and 12-month post-treatment.
Secondary outcome [1] 314585 0
The Spence Children's Anxiety Scale (SCAS) completed by children.
Timepoint [1] 314585 0
Post-treatment; 3-months, 6-months and 12-months post-treatment.
Secondary outcome [2] 314727 0
Spence Children's Anxiety Scale - parent version
Timepoint [2] 314727 0
Post-treatment, 3-month, 6-month and 12-months post-treatment.

Eligibility
Key inclusion criteria
Children aged 7-14 years meeting criteria for at least one anxiety diagnosis on the ADIS-C with a clinical severity rating of 4 or greater. The age of the parents was not considered relevant for inclusion.
Minimum age
7 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Families simultaneously seeking psychological treatment for the children's anxiety elsewhere. Active psychosis in children. Inability to speak English in parents.

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 concealment. Allocation was done centrally by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
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
G*Power was used to determine optimal number of participants required. A moderate effect size was used, with a probability value of <0.05 and a statistical power of 80%.

Analyses will be done using SPSS and will include Chi square analyses, as well as repeated measures ANOVAs.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/05/2009
Actual
27/05/2009
Date of last participant enrolment
Anticipated
Actual
1/02/2010
Date of last data collection
Anticipated
Actual
4/03/2011
Sample size
Target
60
Accrual to date
Final
61
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 9662 0
4067 - St Lucia

Funding & Sponsors
Funding source category [1] 291248 0
Self funded/Unfunded
Name [1] 291248 0
Nil
Country [1] 291248 0
Primary sponsor type
Individual
Name
Vanessa Cobham
Address
School of Psychology
University of Queensland
St. Lucia, Queensland, 4067.
Country
Australia
Secondary sponsor category [1] 289923 0
Individual
Name [1] 289923 0
Matthew Sanders
Address [1] 289923 0
School of Psychology
University of Queensland
St. Lucia, Queensland, 4067.
Country [1] 289923 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292808 0
School of Psychology, University of Queensland
Ethics committee address [1] 292808 0
School of Psychology,
University of Queensland, St. Lucia, QLD, 4067.
Ethics committee country [1] 292808 0
Australia
Date submitted for ethics approval [1] 292808 0
Approval date [1] 292808 0
11/05/2009
Ethics approval number [1] 292808 0
PSYCH-DCP-23-JM

Summary
Brief summary
This project aims to evaluate the efficacy of a 6-session parenting intervention (Fear-less Triple P) in reducing the anxiety symptomatology of anxiety-disordered children aged 7-14 years. Outcomes will be compared with a wait list control group, and will be examined at post-treatment, 3-month, 6-month and 12-month follow-up.
Trial website
Trial related presentations / publications
Cobham, V.E. (2016). Treating anxiety disorders in children: Parents as experts. Keynote address presented at the Families’ Week Forum, Lady Cilento Children’s Hospital, Brisbane, Australia.

Cobham, V.E. (2015). The evaluation of Fear-less Triple P: An intervention for parents of anxiety-disordered children. Paper presented at the British Association for Behavioural and Cognitive Psychotherapies, Warwick, England.

Cobham, V.E. (2013). Fear-less Triple P: A brief intervention for parents of anxiety-disordered youth. Paper presented at the World Congress of Behavioural and Cognitive Therapies, Lima, Peru.

Cobham, V.E. (2013). Fear-less Triple P: What we’ve learned so far. Paper presented at the Helping Families Change Conference, Los Angeles.
Public notes

Contacts
Principal investigator
Name 57118 0
Dr Vanessa Cobham
Address 57118 0
School of Psychology
University of Queensland
St. Lucia, QLD, 4067
Country 57118 0
Australia
Phone 57118 0
+61 7 33469911
Fax 57118 0
Email 57118 0
[email protected]
Contact person for public queries
Name 57119 0
Vanessa Cobham
Address 57119 0
School of Psychology
University of Queensland
St. Lucia, QLD, 4067
Country 57119 0
Australia
Phone 57119 0
+61 7 33469911
Fax 57119 0
Email 57119 0
[email protected]
Contact person for scientific queries
Name 57120 0
Vanessa Cobham
Address 57120 0
School of Psychology
University of Queensland
St. Lucia, QLD, 4067
Country 57120 0
Australia
Phone 57120 0
+61 7 33469911
Fax 57120 0
Email 57120 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

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