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
Ethics application status
Date submitted
Date registered
Date last updated
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)
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

Study type
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
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

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.

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
Both males and females
Can healthy volunteers participate?
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
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
Other design features
Not Applicable
Type of endpoint(s)
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 status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 9662 0
4067 - St Lucia

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

Ethics approval
Ethics application status
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
Date submitted for ethics approval [1] 292808 0
Approval date [1] 292808 0
Ethics approval number [1] 292808 0

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

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

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary