Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000374369
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
5/02/2026
Date registered
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25/03/2026
Date last updated
Help: Date last updated
25/03/2026
Date data sharing statement initially provided
Help: Data sharing statement date
25/03/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
Improving Access to Evidence-based Treatment of Obsessive-Compulsive Disorder for Young People in Community Mental Health Services
Scientific title
Bridging the Science-Service Treatment Gap for Young People with Obsessive Compulsive Disorder (OCD): An Implementation-Effectiveness Trial of Evidence-Based Care in Community Mental Health Services
Additional trial identifiers [1] 316095 0
NIL
Universal Trial Number (UTN)
Trial acronym
The OCD DARE Trial (Detection, Assessment and Recovery Enhancement for OCD)
Related trial records

Health condition
Health condition(s) studied:
Obsessive-Compulsive Disorder 339988 0
Condition category
Condition code
Mental Health 336207 336207 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Strong cognitive-behavioural therapy with exposure and response prevention (CBT-ERP): delivered to young people with parental involvement.

Strong CBT-ERP involves: 12 + 2 manualised youth weekly sessions (group or individual CBT-ERP - determined based on referrals into the services and feasibility for running a group as first preference, versus offering individual therapy in the absence of numbers for a group offering); plus 4 tele-health delivered parent training sessions in ERP; plus at least one 3-hour long intensive ERP session (1-3 intensive sessions as needed for each child). The weekly sessions, parent training and intensive are delivered concurrently. Parent training commences week 1 alongside youth weekly sessions and is space throughout intervention. Intensive sessions are offered anytime from session 4 in the youth treatment following introduction of ERP.

CBT-ERP involves psychoeducation about OCD, symptom monitoring and homework practice, cognitive therapy to address maladaptive beliefs, and graduated exposure to feared stimuli while preventing compulsive responses, alongside relapse prevention planning to consolidate gains and maintain improvements. Intensive sessions involve extended, concentrated ERP practice to accelerate therapeutic gains. Concurrent parent training provides caregivers with structured guidance and coaching to facilitate ERP implementation in the home environment and to overcome practical and behavioural barriers to treatment adherence.

All aspects of the model of care (assessment and treatment) will be delivered by trained mental health clinicians already working in the collaborating youth community mental health services. Clinician training will be delivered prior to any implementation. Clinician supervision will be continually offered throughout the trials. The dose and modality of clinician training and supervision will be co-designed as part of this trial prior to implementation and recruitment. This will occur via focus groups (n=4-6 clinicians per group, two groups in each state) with clinicians at baseline before implementation, and via ongoing consultation during the trial with clinician stakeholders to assess feasibility and acceptability.

Allocation will be based on geographical region where health services clustered together geographically will form one condition (north clinics versus south clinics) - so that services can refer into groups as need be for patients from similar region into the same condition. Allocation will be randomly determined in each state via computer generated randomiser.
Intervention code [1] 332709 0
Early detection / Screening
Intervention code [2] 332710 0
Diagnosis / Prognosis
Intervention code [3] 332711 0
Treatment: Other
Description of the comparator or control
Standard CBT-ERP: no untreated control group (all participants receive evidence-based clinical care).

Standard cognitive-behavioural therapy with exposure and response prevention (CBT-ERP) over 12+2 weekly sessions, delivered individually or in groups (group or individual CBT-ERP - determined based on referrals into the services and feasibility for running a group as first preference, versus offering individual therapy in the absence of numbers for a group offering), including 3 parent sessions incorporated at end of child sessions (approximately weeks 1, 4, 7) related to child program to support implementation at home. This condition also includes service-wide clinician training in screening and diagnosis, alongside manualised CBT-ERP delivered individually or in groups. CBT-ERP involves psychoeducation about OCD, symptom monitoring and homework practice, cognitive therapy to address maladaptive beliefs, and graduated exposure to feared stimuli while preventing compulsive responses, alongside relapse prevention planning to consolidate gains and maintain improvements.
Control group
Active

Outcomes
Primary outcome [1] 343755 0
The primary clinical effectiveness outcomes is obsessive-compulsive symptom severity
Timepoint [1] 343755 0
Post-treatment assessment occurs within one to two weeks following completion of the child’s OCD treatment.
Primary outcome [2] 343757 0
Child acceptability of Intervention.
Timepoint [2] 343757 0
Post-treatment - defined within one to two weeks following completion of the child’s OCD treatment.
Primary outcome [3] 344581 0
Clinician-rated acceptability of the intervention.
Timepoint [3] 344581 0
Post-treatment assessment occurs within one to two weeks following completion of the child’s OCD treatment.
Secondary outcome [1] 455498 0
OCD-related functional impairment - Child Rated
Timepoint [1] 455498 0
Post-treatment. Post-treatment assessment occurs within one to two weeks following completion of the child’s OCD treatment.
Secondary outcome [2] 455499 0
Family accomodation of child OCD.
Timepoint [2] 455499 0
Post-treatment. Post-treatment assessment occurs within one to two weeks following completion of the child’s OCD treatment.
Secondary outcome [3] 455500 0
OCD Diagnostic status (remission)
Timepoint [3] 455500 0
Post-treatment. Post-treatment assessment occurs within one to two weeks following completion of the child’s OCD treatment.
Secondary outcome [4] 455501 0
Incremental cost per quality-adjusted life year (QALY) gained
Timepoint [4] 455501 0
Post-treatment. Post-treatment assessment occurs within one to two weeks following completion of the child’s OCD treatment.

Eligibility
Key inclusion criteria
Child and adolescents that may be suitable for the program include those meeting the following criteria: (a) Aged 6–18 years (although some variability is expected within the services, and may include participants aged slightly younger or older, e.g., 5 or 19 years old); (b) screen-positive and/or diagnosed with OCD using validated tools (e.g., OCD diagnostic module); (c) receives care at a participating community mental health service; and (d) informed consent obtained for participation in research and data collection (consent from caregiver given for 17 and below, with assent from the young person).

All clinicians within the participating health services will be offered the foundational training (training in screening and detection of OCD). To be eligible to participate as clinicians for foundational training, individuals must be: (a) employed by a participating mental health service; (b) involved in delivery or supervision of clinical services for youth; (c) registered with the relevant professional body for their profession, e.g., AHPRA; and (d) meet registration language requirements i.e., fluency in English.

To be eligible to participate as a treating clinician, individuals must meet inclusion criteria above as well as the following criteria: (a) approved by their supervisor/clinical team lead to participate in training and delivery of the MoC; and (b) available and willing to attend training, participate in supervision, and deliver the MoC.

Parent inclusion includes: child meeting above criteria, and parent will to participate in parent components of treatment.
Minimum age
6 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Child and adolescents may be deemed unsuitable for the program if (a) co-occurring medical condition that poses a risk to participating, (b) primary eating disorder that require priority intervention, (c) substance use disorder, (d) psychotic disorder, (e) active suicidality or risk requiring inpatient admission, or (f) intellectual impairment.

Clinicians (treating clinicians) will be excluded from participating if they are unavailable during key project phases (e.g., due to extended leave or resignation).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Clinical effectiveness analyses will use an intention-to-treat framework. The primary outcome will be analysed using mixed-effects linear models, treatment included as the main effect, baseline CYBOCS as a covariable and with patient included as a random effect. Analyses will be adjusted for service setting/clustering of clinicians, if appropriate. Secondary outcomes will be analysed using either linear (continuous data), logistic (binary data) or Poisson (count data) mixed-effects models. Sensitivity of analyses to missing data will be investigated using multiple imputation. Economic evaluation will compare the two models of care using a Markov cohort model to estimate long-term costs and QALYs from health-sector and societal perspectives.

Quantitative implementation outcome (e.g., feasibility, acceptability) measures, will be analysed descriptively using frequencies, means, and standard deviations, as relevant. Mixed ANOVAs will be employed to compare both between-subject (e.g., training condition) and within-subject effects (e.g., effect of training). Associations between variables will be explored using Pearson’s correlations. Effect sizes will be reported to indicate the magnitude of the effect.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2026
Actual
Date of last participant enrolment
Anticipated
30/07/2029
Actual
Date of last data collection
Anticipated
30/11/2029
Actual
Sample size
Target
368
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD

Funding & Sponsors
Funding source category [1] 320693 0
Government body
Name [1] 320693 0
National Health and Medical Research Council
Country [1] 320693 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Country
Australia
Secondary sponsor category [1] 323671 0
None
Name [1] 323671 0
Address [1] 323671 0
Country [1] 323671 0
Other collaborator category [1] 283783 0
Government body
Name [1] 283783 0
Children's Health Queensland
Address [1] 283783 0
Country [1] 283783 0
Australia
Other collaborator category [2] 283784 0
Government body
Name [2] 283784 0
South Eastern Sydney Local Health District
Address [2] 283784 0
Country [2] 283784 0
Australia
Other collaborator category [3] 283785 0
Government body
Name [3] 283785 0
Sydney Children's Hospitals Network
Address [3] 283785 0
Country [3] 283785 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319235 0
Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 319235 0
Ethics committee country [1] 319235 0
Australia
Date submitted for ethics approval [1] 319235 0
14/11/2025
Approval date [1] 319235 0
16/12/2025
Ethics approval number [1] 319235 0
HREC/2025/QCHQ/124011

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

Contacts
Principal investigator
Name 146698 0
Prof Lara Farrell
Address 146698 0
Griffith Centre for Mental Health, School of Applied Psychology, Griffith University, 1 Parklands Drive, Southport, QLD 4222
Country 146698 0
Australia
Phone 146698 0
+61 7 5678 8224
Fax 146698 0
Email 146698 0
[email protected]
Contact person for public queries
Name 146699 0
Professor Lara Farrell
Address 146699 0
Griffith Centre for Mental Health, School of Applied Psychology, Griffith University, 1 Parklands Drive, Southport, QLD 4222
Country 146699 0
Australia
Phone 146699 0
+61 7 5678 8224
Fax 146699 0
Email 146699 0
[email protected]
Contact person for scientific queries
Name 146700 0
Professor Lara Farrell
Address 146700 0
Griffith Centre for Mental Health, School of Applied Psychology, Griffith University, 1 Parklands Drive, Southport, QLD 4222
Country 146700 0
Australia
Phone 146700 0
+61 7 5678 8224
Fax 146700 0
Email 146700 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After all analyses are completed and outcomes published.

To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
Yes: Requests will be balanced based on additional considerations of on cost and demand on time to research team / sponsor to facilitate such requests.



What supporting documents are/will be available?

No Supporting Document Provided


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.