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Trial registered on ANZCTR


Registration number
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ACTRN12626001221347
Ethics application status
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Approved
Date submitted
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2/06/2026
Date registered
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7/10/2026
Date last updated
Help: Date last updated
7/10/2026
Date data sharing statement initially provided
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7/10/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
Treating Childhood Specific Phobias Fast: A nationwide randomised controlled trial of Families Accessing Cognitive Behaviour Therapy Skills Training (FAST) in Exposure Therapy to
Scientific title
Treating Childhood Specific Phobias Fast: A nationwide randomised controlled trial of Families Accessing Cognitive Behaviour Therapy Skills Training (FAST) in Exposure Therapy
Additional trial identifiers [1] 317048 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Specific Phobia 341560 0
Condition category
Condition code
Mental Health 337637 337637 0 0
Anxiety
Mental Health 338420 338420 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The intervention is Families Accessing Skills Training in Cognitive Behaviour Therapy (FAST-CBT), a parent-led exposure therapy program designed to help children overcome specific phobias by training caregivers to act as “exposure coaches.” The program is based on the principles of One-Session Treatment (OST) and incorporates core evidence-based components including psychoeducation, participant modelling, graded exposure therapy, behavioural experiments, positive reinforcement, and parent coaching. The intervention materials, including the online modules and parent workbook, were specifically developed for this study and piloted previously and are informed by established CBT and exposure therapy approaches for childhood specific phobias. The intervention is delivered by masters-level clinicians with training in CBT and exposure therapy under the supervision of an experienced clinical psychologist. The program is delivered using a multi-technology format consisting of four online self-directed modules (approximately 30 minutes each), three weekly one-hour group telehealth sessions, a booster session (one hour), and individual videoconference check-ins (15-30 minutes each for three weeks following completion of modules).

The online modules provide psychoeducation about anxiety and specific phobias, the role of avoidance in maintaining fear, principles of exposure therapy, identifying maladaptive threat appraisals, developing exposure hierarchies (“Facing Plans”), implementing behavioural experiments, using praise and rewards to reinforce brave behaviour, supporting exposure practice, managing setbacks, and maintaining treatment gains. Parents are provided with practical activities, worksheets, examples, and home practice tasks to complete with their child between sessions.

The weekly group telehealth sessions are clinician-led and involve reviewing module content, discussing key CBT and exposure therapy concepts, developing and refining exposure hierarchies, troubleshooting implementation challenges, group discussion, sharing experiences, and providing clinician guidance on conducting exposures safely and effectively. The booster session focuses on maintaining gains, addressing setbacks, reviewing progress, reinforcing key treatment principles, and supporting ongoing exposure practice and relapse prevention.

Brief individual check-ins are conducted with parents throughout the intervention to monitor progress and support implementation. During these sessions, clinicians review target symptoms, homework adherence, parent confidence in conducting exposures, and progress on exposure hierarchies. Clinicians also assist parents in troubleshooting any barriers encountered, refining exposure tasks, and continuing to build and progress exposure ladders appropriate to the child's needs.

Parents and children are expected to complete weekly home practice tasks between sessions, with the amount of practice recommended being daily (time varies based on exposure task) wherever possible. These include constructing and updating exposure hierarchies, conducting regular exposure exercises, implementing reward systems, and practising exposure tasks on a daily basis. Home practice is considered a core component of the intervention and is supported through clinician guidance, progress monitoring, and discussion during group sessions and check-ins. Adherence is supported through embedded progress monitoring within the online platform, clinician guidance during sessions, regular check-ins, and tracking of homework and exposure practice to promote engagement and ongoing implementation of skills.
Intervention code [1] 333805 0
Behaviour
Intervention code [2] 333806 0
Treatment: Other
Description of the comparator or control
The comparator is a Care as Usual (CAU) condition, in which participants continue with their existing care or seek any treatment available in the community that is not part of the FAST-CBT program. Care is delivered by community-based providers (e.g., psychologists, GPs, or other health professionals) with relevant qualifications and expertise, depending on the services families independently access. The comparator is delivered in a naturalistic format, meaning treatment may occur face-to-face, online, individually, or in groups, depending on the provider and service accessed. There is no standardised frequency or duration, as care is not controlled by the study; however, the comparator period spans 8 weeks, during which participants continue usual care. The setting is community-based (e.g., clinics, private practices, telehealth, or home-based supports). Adherence is not actively managed by the research team, but participants are monitored through study assessments, and families are provided with a list of available services to support access to care during this period.
Control group
Active

Outcomes
Primary outcome [1] 345119 0
Phobia Diagnosis
Timepoint [1] 345119 0
pre-treatment, post-treatment, 6 month follow up
Primary outcome [2] 345120 0
Global Functioning.
Timepoint [2] 345120 0
pre-treatment, 6 month follow up
Secondary outcome [1] 460544 0
Child psychopathology symptoms
Timepoint [1] 460544 0
pre-treatment, post-treatment
Secondary outcome [2] 460545 0
Child anxiety
Timepoint [2] 460545 0
pre-treatment, post-treatment
Secondary outcome [3] 460546 0
Family Accommodation
Timepoint [3] 460546 0
pre-treatment, post-treatment
Secondary outcome [4] 460547 0
Child impact from anxiety.
Timepoint [4] 460547 0
pre-treatment, post-treatment
Secondary outcome [5] 463072 0
Child depression.
Timepoint [5] 463072 0
Pre-treatment, post-treatment

Eligibility
Key inclusion criteria
Key inclusion criteria for the study are that participants are children aged 3 to 12 years who meet criteria for a clinical diagnosis of a specific phobia (Clinical Severity Rating > 4), as determined by structured assessment. Children must have at least one caregiver willing to participate in the parent training program, and families must have access to the internet and videoconferencing (e.g., Microsoft Teams) to engage in the intervention. If the child is taking medication, this must be stable for at least 12 weeks prior to participation.

Parent inclusion criteria. Child with a primary anxiety disorder; child with a specific phobia willing to participate in this research; english speaking; no obvious intellectual impairment that would make participating challenging for parent; willingness to be randomised to condition.
Minimum age
3 Years
Maximum age
65 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Key exclusion criteria include children whose primary diagnosis is not an anxiety disorder, or whose primary presenting problem is a blood-injection-injury (BII) specific phobia. Children are also excluded if they present with psychosis, moderate-to-severe autism (Level 2 or above), suicidal risk, or impaired intellectual functioning. Additionally, children currently receiving concurrent psychological treatment are excluded from the FAST-CBT condition (though this is permitted in the care-as-usual group).

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 will be ensured through central computer-generated randomisation, Allocation is determined only after participants have completed baseline assessment and been deemed eligible, and the investigators responsible for eligibility assessment are not involved in the randomisation process and are unaware of group allocation at the time of enrolment. This procedure ensures that allocation is concealed from those determining
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be conducted using a computer-generated sequence with permuted block randomisation to ensure balanced allocation across groups. Participants will be allocated in a 1:1 ratio to either the FAST-CBT or care-as-usual condition. Randomisation will be stratified by age group (3–7 years and 8–12 years) to ensure balanced representation across developmental stages.
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
Sample size calculations were informed by outcomes from previous trials of parent-led cognitive behavioural therapy for child anxiety (Comer et al., 2021; Creswell et al., 2017; Thirlwall et al., 2013), an earlier OST trial for preschool-aged children with SPs (Farrell et al., in prep), and pilot data from the FAST-CBT program for paediatric OCD (ARH, 2023). Based on these data, it is conservatively estimated that approximately 60% of children allocated to FAST-CBT will remit from SP at the post-treatment assessment (8 weeks), compared to 30% in the CAU condition. To detect this difference with 90% power at a two-sided alpha level of 0.05, outcome data are required for 112 children. Allowing for an anticipated attrition rate of up to 20%, a total sample size of N = 140 children will be recruited.

The primary outcome will be analysed using logistic regression, with treatment condition entered as the main predictor. Results will be reported as odds ratios with corresponding 95% confidence intervals. Secondary outcomes will be analysed using regression models appropriate to the distribution of the outcome variable, including linear regression for continuous outcomes, logistic regression for binary outcomes, and Poisson regression for count data. For outcomes assessed across multiple time points, mixed-effects models will be employed, with child included as a random effect to account for the non-independence of repeated observations within individuals. All analyses will be conducted on an intention-to-treat basis, with statistical significance set at p = 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/10/2026
Actual
Date of last participant enrolment
Anticipated
1/06/2028
Actual
Date of last data collection
Anticipated
1/12/2028
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 321643 0
Charities/Societies/Foundations
Name [1] 321643 0
Australian Rotary Health
Country [1] 321643 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Country
Australia
Secondary sponsor category [1] 324463 0
None
Name [1] 324463 0
Address [1] 324463 0
Country [1] 324463 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320169 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 320169 0
Ethics committee country [1] 320169 0
Australia
Date submitted for ethics approval [1] 320169 0
13/02/2026
Approval date [1] 320169 0
19/03/2026
Ethics approval number [1] 320169 0

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

Contacts
Principal investigator
Name 149662 0
Prof Lara Farrell
Address 149662 0
Griffith University, School of Applied Psychology, Building G40, Level 7, 1 Parklands Drive, Southport, Queensland 4222
Country 149662 0
Australia
Phone 149662 0
+61 402203808
Fax 149662 0
Email 149662 0
[email protected]
Contact person for public queries
Name 149663 0
Lara Farrell
Address 149663 0
Griffith University, School of Applied Psychology, Building G40, Level 7, 1 Parklands Drive, Southport, Queensland 4222
Country 149663 0
Australia
Phone 149663 0
+61 402203808
Fax 149663 0
Email 149663 0
[email protected]
Contact person for scientific queries
Name 149664 0
Lara Farrell
Address 149664 0
Griffith University, School of Applied Psychology, Building G40, Level 7, 1 Parklands Drive, Southport, Queensland 4222
Country 149664 0
Australia
Phone 149664 0
+61 402203808
Fax 149664 0
Email 149664 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    Human Ethics Application - HREA form_ApprovalLetter_30795_16_Apr_2026.pdf


Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.