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Trial registered on ANZCTR


Trial ID
ACTRN12613001150730
Ethics application status
Approved
Date submitted
11/10/2013
Date registered
15/10/2013
Date last updated
25/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
How to be Brave; Program to treat specific phobia in children and Prevent anxiety and depression in adolescence and adulthood.
Scientific title
A Randomised Controlled Trial comparing one-session therapy (Active version) for childhood specific phobia vs. waitlist control (Control version).
Secondary ID [1] 283391 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Specific Phobia in children (phobia of falling from high places and phobia of small enclosed spaces) 290288 0
Condition category
Condition code
Mental Health 290682 290682 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This One Session Treatment is conducted over one 3-hour session and involves the child gradually facing their fears of falling from heights or small enclosed spaces (‘graded exposure’). The child and therapist build a step ladder of activities/events ranging from the least anxiety provoking to the most. The therapist models how to face the feared object or situation step by step, and then supports the child to replicate the exposure. Research suggests this treatment is effective. OST is carried out by a trained and qualified clinical psychologist.

Only phobias of falling from heights and enclosed spaces will be addressed in this trial.

OST will be carried out at the end of the current school term in which the participant consents to participate. The treatment will be run in a small group of other children and parents. Participants with a fear of heights will be treated as one group and participants with a fear of enclosed spaces will be treated as a separate group. Research suggests that group CBT for children is effective as they are familiar with learning in a group environment (school) and are able to support and celebrate each other's achievements.
Intervention code [1] 288117 0
Treatment: Other
Comparator / control treatment
One-session treatment (OST) of graded exposure to feared stimuli (heights or small enclosed space) lasting up to three hours will be carried out at the end of the following school term in which the participant consents to participate. This group will receive the same treatment as the intervention group at the end of the following school term, after the intervention group have received treatment. This is a waitlist control group.

OST is carried out by a trained and qualified clinical psychologist.

Control group
Active

Outcomes
Primary outcome [1] 290700 0
Change in Behavioural Avoidance Test (BAT) scores
Timepoint [1] 290700 0
Administered at base-line; T1 (before start of intervention), post intervention; T2 (immediately after intervention) and 6-month follow up; T3.
Primary outcome [2] 290701 0
Fears Survey Schedule for Children- Revised (FSSC-R)
Timepoint [2] 290701 0
Pre intervention; T1.
Secondary outcome [1] 305064 0
OST participant attendance
Timepoint [1] 305064 0
Attendance numbers collected immediately after treatment

Eligibility
Key inclusion criteria
Must have completed the THIS WAY UP Schools online stress management course at school.

Must be in years 5 or 6 of primary school,

Must score highly on the questions taken from the Fears Survey Schedule in Children- Revised (FSSC-R)

Must state that their fear identified by the FSSC-R stops them from doing what they would like to do
Minimum age
8 Years
Maximum age
11 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil

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)
The Stress Management course is currently being used by primary and secondary schools across Australia as part of the Personal Development Health and Physical Education curriculum. Details of the course can be accessed at www.thiswayup.org.au/schools.

Students who meet eligibility criteria will receive a letter (as well as their parents) inviting them to participate in the trial. Students and parents who consent will be enrolled in the trial.



Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The schools will be randomised as opposed to the individual participants to avoid contamination. Participating schools will be randomised using a list generated prior to the study.

Allocation concealment will occur in the following way: A staff member not involved in the clinical trial will generate the sequence using computer software and place each choice in a sequentially numbered, opaque sealed and stapled envelope.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis
We expect pre-post improvement of of effect size (ES) 1.0 for the OST group on the Behavioural Avoidance Test scores. It is also expected that the OST group will improve more than the waitlist control group by an ES of >0.8, power at 80% and alpha set at 0.5.

Analyses will be undertaken using mixed-model repeated measures (MMRM) ANOVA with measurement time point as a within-groups factor and intervention as a between-groups factor.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 288114 0
Commercial sector/Industry
Name [1] 288114 0
BUPA (The British United Provident Association Limited; a company which provides private medical insurance)
Address [1] 288114 0
Bupa
GPO Box 9809
Brisbane, QLD 4001
Australia
Country [1] 288114 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Bupa
Address
Bupa
GPO Box 9809
Brisbane, QLD 4001
Australia
Country
Australia
Secondary sponsor category [1] 286835 0
None
Name [1] 286835 0
Nil
Address [1] 286835 0
Nil
Country [1] 286835 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290038 0
St. Vincent's Hospital HREC
Ethics committee address [1] 290038 0
St. Vincent's Hospital
394-404 Victoria St
Darlinghurst, 2010
NSW
Ethics committee country [1] 290038 0
Australia
Date submitted for ethics approval [1] 290038 0
12/07/2013
Approval date [1] 290038 0
06/08/2013
Ethics approval number [1] 290038 0
HREC/13/SVH/147

Summary
Brief summary
After completing the online managing stress course and OST children will be skilled in mastering irrational fears and will have improved mental health and wellbeing. They will be better equipped to confront difficult situations in school and in play.

Evidence strongly points to the prevention of the onset of anxiety and depressive disorders in adults through the treatment of fears in children (Kessler et al., 2011).

The rationale for this study is to demonstrate the efficacy of identifying children in primary school with specific phobia and using early intervention (OST) to reduce the risk of anxiety and depressive disorders later in adolescence and adulthood.

The main hypothesis is:
Participants who were randomised and attended the OST will have reduced fears (lower BAT scores) after treatment compared to the waitlist control group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43618 0
A/Prof Gavin Andrews
Address 43618 0
Clinical Research Unit for Anxiety and Depression, St Vincent’s Hospital, Victoria St, Darlinghurst, 2010. NSW
Country 43618 0
Australia
Phone 43618 0
+612 8382 1405
Fax 43618 0
Email 43618 0
gavina@unsw.ed.au
Contact person for public queries
Name 43619 0
Ms Louise Brownhill
Address 43619 0
Clinical Research Unit for Anxiety and Depression, St Vincent’s Hospital, Victoria St, Darlinghurst, 2010. NSW
Country 43619 0
Australia
Phone 43619 0
+612 8382 1541
Fax 43619 0
Email 43619 0
l.brownhill@unsw.edu.au
Contact person for scientific queries
Name 43620 0
Ms Louise Brownhill
Address 43620 0
Clinical Research Unit for Anxiety and Depression, St Vincent’s Hospital, Victoria St, Darlinghurst, 2010. NSW
Country 43620 0
Australia
Phone 43620 0
+612 8382 1541
Fax 43620 0
Email 43620 0
l.brownhill@unsw.edu.au