Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000706370
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
26/04/2026
Date registered
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12/06/2026
Date last updated
Help: Date last updated
12/06/2026
Date data sharing statement initially provided
Help: Data sharing statement date
12/06/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
Families Accessing Skills Training in Exposure and Response Prevention (FAST ERP) for Child and Youth Obsessive-Compulsive Disorder (OCD)
Scientific title
Effectiveness of Families Accessing Skills Training in Exposure and Response Prevention (FAST ERP) for Child and Youth Obsessive-Compulsive Disorder (OCD): A Nationwide Non-Inferiority Randomised Controlled Trial
Additional trial identifiers [1] 316825 0
2045896
Universal Trial Number (UTN)
Trial acronym
FAST-ERP for OCD
Related trial records

Health condition
Health condition(s) studied:
obsessive-compulsive disorder 341181 0
Condition category
Condition code
Mental Health 337269 337269 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
FAST-ERP. The multi-technology intervention involves two components, a) parents accessing web-based modules and b) parents participating in group telehealth training sessions.
a) Web-based modules. OCD Busters parent training web-based modules, hosted on Griffith servers via secure parent login, consisting of 4 educational modules training parents to be ‘ERP coaches’, managing child OCD symptoms, and reducing family accommodation. The content of the 4 modules includes (1) Psychoeducation on ERP – explaining its purpose and how it is used to treat OCD; (2) Facing and Fighting Plans – developing fear hierarchies for ERP; (3) OCD Busting – how to implement ERP at home and in various contexts using contingency management strategies; and (4) Overcoming Obstacles – addressing common obstacles for the parent, child, and context in implementing ERP. The parents work independently through one module a week for 4 weeks. At the start of each of the four ~30-minute web-based modules, parents complete brief online progress ratings (parent confidence, child motivation, and recent OCD severity/interference), the full parent-rated Child Yale-Brown Obsessive Compulsive Scale (CY-BOCS) at enrolment, and a weekly 10-item CY-BOCS checklist, with all responses securely stored in the program backend for later download and analysis. The web-based program (https://ocdbusters.griffith.edu.au) is hosted by Griffith University and was launched July 2022 following extensive security testing by Griffith’s Digital Solutions. This treatment protocol has been piloted and trialled in videoconference format (Farrell & Waters, 2008; Farrell et al., 2022)

b) Parent group telehealth sessions. The second component involves parents to participate in 4 weekly, one hour small group parent sessions delivered via videoconference (Microsoft Teams), facilitated by a masters-level clinician (supervised by CI Farrell) to support implementation of ERP. The parent sessions will consist of 4-6 parents. The content of sessions focusses on discussion of the content delivered in the corresponding web-based modules, and involves discussion of how parents will implement strategies at home, including setting homework tasks, problem solving challenges, and strategies to support children's progress at home.

Monitoring
Following the web-based and telehealth group meetings (after session 4), a single, one-hour joint parent–child telehealth session will be conducted by a clinician to review progress, implement ERP strategies, and support ongoing exposure practice. It is scheduled in the 2-3 weeks following module 4. In addition, parents will receive a brief weekly 15-minute clinician check-in call to reinforce and encourage continued ERP implementation. Finally, a tele-health group booster session (via Microsoft Teams) will be held at Week 8 to reconvene parents, review progress, and support planning for continued ERP practice with their children.
Intervention code [1] 333510 0
Behaviour
Description of the comparator or control
The comparator condition in this trial is Youth Exposure and Response Prevention (Youth-ERP), an active control representing the current gold-standard, evidence-based treatment for paediatric obsessive–compulsive disorder (OCD). The study is designed to evaluate whether the multi-technology parent-led intervention (FAST-ERP) is non-inferior to this gold-standard treatment.

Youth-ERP is a manualised, individual treatment program delivered via secure telehealth videoconferencing. The intervention consists of nine weekly sessions, each approximately 60 minutes in duration, delivered over a 9-week period. Treatment is provided individually to the child by a trained clinician and includes three conjoint parent–child sessions to support skill acquisition, generalisation of strategies, and family involvement in treatment.

The intervention is guided by the OCD Busters manual (Farrell & Waters, 2008), an empirically supported program aligned with international best-practice guidelines for the treatment of paediatric OCD. Core components include psychoeducation, cognitive therapy strategies, and graded exposure and response prevention (ERP) conducted both within sessions and as between-session homework tasks, as well as relapse prevention planning. Treatment fidelity is supported through adherence to the manual and ongoing clinical supervision.

Delivery is via telehealth (videoconferencing; Microsoft Teams or equivalent secure platform), ensuring consistency with the delivery mode of the intervention condition. The total treatment “dose” comprises approximately 9 hours of clinician contact, in addition to between-session ERP practice.

Booster Sessions
Following the Youth-ERP program, an individual booster session will be conducted by a clinician at Week 13 to review progress, reinforce and implement ERP strategies, and support planning for continued exposure practice.
Control group
Active

Outcomes
Primary outcome [1] 344781 0
Obsessive-compulsive disorder
Timepoint [1] 344781 0
baseline, post-treatment, 6 month follow up (primary end point), 12 month follow up
Primary outcome [2] 345725 0
Cost-Effectiveness. Costs associated with treatment will be collected as part of the trial, with hospital presentations, Medicare and prescription medication utilisation accessed from administrative databases. The primary outcome will be the incremental cost per quality adjusted life year gained (QALY) from a health system perspective.
Timepoint [2] 345725 0
baseline, 6 month follow up, 12 month follow up
Secondary outcome [1] 459155 0
Diagnostic status of OCD - this will be assessed as a composite outcome
Timepoint [1] 459155 0
baseline, post-treatment, 6 month follow up, 12 month follow up
Secondary outcome [2] 459156 0
obsessive-compulsive disorder impairment
Timepoint [2] 459156 0
baseline, 6 month follow up
Secondary outcome [3] 459157 0
Family accommodation
Timepoint [3] 459157 0
baseline, 6 month follow up
Secondary outcome [4] 459163 0
Child Anxiety
Timepoint [4] 459163 0
baseline, 6 month follow up
Secondary outcome [5] 462598 0
Child Depression
Timepoint [5] 462598 0
Baseline, 6 month follow up
Secondary outcome [6] 463067 0
Quality of Life.
Timepoint [6] 463067 0
Baseline, 6 month follow up, 12 month follow-up.

Eligibility
Key inclusion criteria
For youth: (1) youth 7 to 18 years; (2) primary diagnosis of OCD, as assessed by DSM-5 compatible Anxiety Disorders Interview Schedule for Children - Parent Interview; (3) willingness to be randomised to one of two active treatments; (4) lives with a parent who is willing and able to attend telehealth sessions; (5) English speaking; (6) stable dose of any psychopharmacotherapy 12 weeks (since initiation) or 6 weeks (since dose change) prior to entry and willingness to remain on stable dose. For Parents: (1) english speaking; (2) willingness to participate in a parent-led intervention; (3) access to internet.
Minimum age
7 Years
Maximum age
65 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
(1) concurrent psychotherapy; (2) child comorbid conduct disorder, bipolar, psychotic illness, eating disorder, or substance abuse; (3) symptoms consistent with PANS/PANDAS given the acute and fluctuating nature (Murphy et al., 2005; Swedo et al., 1998; 2002) and lack of consensus regarding diagnosis (Swedo et al., 2004). CI Farrell & Perkes will consult regarding each suspected case; (4) active suicidality; (5) suspected impaired IQ making completion of measures challenging (parent & child).

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 randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Following informed consent/assent and once meeting inclusion, youth will be randomly allocated to either (a) FAST-ERP or (b) Youth-ERP in a 1:1 ratio using permuted blocks (random blocks of 4 to 6), stratified by age (13 yrs). The sequence will be computer-generated.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Primary outcomes will be analysed using mixed-effects linear regression models with treatment condition specified as the fixed effect, baseline CY-BOCS score included as a covariate, and participant specified as a random effect to account for within-subject correlation. Secondary outcomes will be analysed using mixed-effects models appropriate to the distribution of the outcome variable, including linear models for continuous outcomes, logistic models for binary outcomes, and Poisson models for count data, using the complete sample following completion of FAST-ERP. An economic evaluation, will assess the incremental cost-effectiveness of FAST-ERP relative to the comparator from both health service and societal perspectives.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/06/2026
Actual
Date of last participant enrolment
Anticipated
3/09/2029
Actual
Date of last data collection
Anticipated
2/12/2030
Actual
Sample size
Target
238
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 321418 0
Government body
Name [1] 321418 0
Department of Health, Disability and Ageing - Medical Research Future Fund
Country [1] 321418 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Country
Australia
Secondary sponsor category [1] 324164 0
None
Name [1] 324164 0
Address [1] 324164 0
Country [1] 324164 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319957 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 319957 0
Ethics committee country [1] 319957 0
Australia
Date submitted for ethics approval [1] 319957 0
19/03/2026
Approval date [1] 319957 0
31/03/2026
Ethics approval number [1] 319957 0

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

Contacts
Principal investigator
Name 148958 0
Prof Lara Farrell
Address 148958 0
School of Applied Psychology, Griffith University, Gold Coast Campus, 1 Parklands Drive, Southport, QLD, 4222
Country 148958 0
Australia
Phone 148958 0
+61 7 5678 8224
Fax 148958 0
Email 148958 0
[email protected]
Contact person for public queries
Name 148959 0
Lara Farrell
Address 148959 0
School of Applied Psychology, Griffith University, Gold Coast Campus, 1 Parklands Drive, Southport, QLD, 4222
Country 148959 0
Australia
Phone 148959 0
+61 7 5678 8224
Fax 148959 0
Email 148959 0
[email protected]
Contact person for scientific queries
Name 148960 0
Lara Farrell
Address 148960 0
School of Applied Psychology, Griffith University, Gold Coast Campus, 1 Parklands Drive, Southport, QLD, 4222
Country 148960 0
Australia
Phone 148960 0
+61 7 5678 8224
Fax 148960 0
Email 148960 0
[email protected]

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


What supporting documents are/will be available?



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.