Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000477628
Ethics application status
Approved
Date submitted
20/04/2023
Date registered
11/05/2023
Date last updated
16/06/2023
Date data sharing statement initially provided
11/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Families Accessing online Skills Training in Cognitive Behaviour Therapy (FAST-CBT) for Paediatric Obsessive Compulsive Disorder (OCD): A nationwide randomised controlled trial
Scientific title
The Effect of FAST-CBT on paediatric OCD symptom severity, impairment and quality of life: A nationwide randomised controlled trial
Secondary ID [1] 309361 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Families Accessing online Skills Training in Cognitive Behavioural Therapy (FAST-CBT)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obsessive Compulsive Disorder (OCD) 329571 0
Condition category
Condition code
Mental Health 326494 326494 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention Condition: FAST-CBT
Parents randomised to the FAST-CBT group receive a login to the web portal: https://ocdbusters.griffith.edu.au/ which contains physical and informational materials. Specifically, a downloadable parent and child workbook which is aligned with the content of the 8 online modules. The web portal procedures, activities and processes are made up of an evaluation component (parent and child OCD symptom ratings and child-reported interference ratings, and parent-reported parental competence ratings), psycho-education about OCD, CBT with exposure-response prevention (ERP) techniques and homework to practice content learned. Homework activities will be a minimum of one exposure practice task per week (depending on task, this can take between 10 - 30 minutes to complete). The online modules and workbook content has been designed specifically for this study.

Group-based procedures, activities and processes include reflection, problem-solving and goal setting. Clinicians (i.e., provisional psychologists, general psychologists or clinical psychologists) with minimum Master of Clinical Psychology qualification and a minimum of 2 years experience will deliver the group sessions (60 minutes per session x4). The intervention is delivered to parents via a mix of online modules, workbook content and clinician facilitated group sessions via videoconference. The maximum number of participants per group is 6 (one clinician per group).

Groups occur once a week over four weeks. The online modules need to be completed between group sessions. There is anticipated to be between 10 - 15 groups over the 3 years of the trial, and the intervention occurs in the home.

The software for the web portal is able to capture parent progress and will alert the clinician if parents are falling behind with completion of modules, so that clinicians can check-in and help trouble-shoot any issues. Initial groups will be co-facilitated by clinicians who have been trained in the intervention and regular clinical meetings will occur to ensure intervention fidelity is maintained throughout the trial.
Intervention code [1] 325790 0
Treatment: Other
Comparator / control treatment
8-week waitlist condition
Control group
Active

Outcomes
Primary outcome [1] 334342 0
OCD symptom severity via the Children's Yale Brown Obsessive Compulsive Scale (CY-BOCS)
Timepoint [1] 334342 0
Pre-treatment/Week 0 (baseline), Post-treatment/Week 8 (primary timepoint) and Follow-up/Week 32 (6 months after baseline)
Primary outcome [2] 334343 0
OCD-related impairment via Child OCD Impact Scale - Parent Rated
Timepoint [2] 334343 0
Post-treatment/Week 8 (8-weeks after baseline)
Primary outcome [3] 334603 0
Child and Parent rated Quality of Life via KiddyKINDL/KidKINDL and EuroQol (EQ) 5D Youth/Proxy
Timepoint [3] 334603 0
Follow-up/Week 32 (for FAST-CBT group only).
Secondary outcome [1] 420291 0
Family accommodation via the Family Accommodation Scale for OCD
Timepoint [1] 420291 0
Pre-treatment/Week 0 (baseline), Post-treatment/Week 8 and Follow-up/Week 32 (6 months after baseline)
Secondary outcome [2] 421366 0
Global functioning via the Children's Global Assessment Scale (CGAS)
Timepoint [2] 421366 0
Post-treatment/Week 8 (8-weeks after baseline)
Secondary outcome [3] 421367 0
OCD severity via the the National Institute of Mental Health-Global Obsessive–Compulsive Scale (NIMH-GOCS)
Timepoint [3] 421367 0
Follow-up/Week 32 (for FAST-CBT group only)

Eligibility
Key inclusion criteria
4-12 years; OCD symptoms / diagnosis; willing to participate; if on anti-depressant medication, stable dose for 8 weeks prior to entry and for duration of trial.
Minimum age
4 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Organic mental disorder; psychosis; autism (level 2-3); suicidality; concurrent therapy; impaired IQ.

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 is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation
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
Primary outcomes will be analysed using a mixed-effects linear regression model, with treatment included as the main effect, baseline OCD symptoms as the co-variable and patient included as a random effect. Secondary outcomes will be analysed using either linear (continuous), logistic (binary) or Poisson (count data) mixed-effects models using complete sample (following completion of intervention. An economic analysis overseen will evaluate the incremental cost-effectiveness of FAST-CBT from a health services and societal perspective.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/05/2023
Actual
Date of last participant enrolment
Anticipated
15/05/2025
Actual
Date of last data collection
Anticipated
20/10/2025
Actual
Sample size
Target
90
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313557 0
Charities/Societies/Foundations
Name [1] 313557 0
Australian Rotary Health
Country [1] 313557 0
Australia
Primary sponsor type
University
Name
Griffith Centre for Mental Health and Griffith University School of Applied Psychology, Griffith University
Address
1 Parklands Drive
Southport
Queensland, 4215
Country
Australia
Secondary sponsor category [1] 315337 0
None
Name [1] 315337 0
Address [1] 315337 0
Country [1] 315337 0
Other collaborator category [1] 282606 0
University
Name [1] 282606 0
Discipline of Psychiatry and Mental Health, University of New South Wales
Address [1] 282606 0
Discipline of Psychiatry and Mental Health, AGSM Building (G27), Gate 11, Botany St, UNSW Sydney Campus, Kensington NSW 2052
Country [1] 282606 0
Australia
Other collaborator category [2] 282607 0
University
Name [2] 282607 0
School of Psychology, UNSW Sydney
Address [2] 282607 0
School of Psychology, UNSW Sydney, Mathews Building (F23), Library Walk, Kensington NSW 2052
Country [2] 282607 0
Australia
Other collaborator category [3] 282608 0
University
Name [3] 282608 0
Centre for Health Research and School of Psychology and Wellbeing, University of Southern Queensland
Address [3] 282608 0
Centre for Health Research, University of Southern Queensland, Springfield Campus, 37 Sinnathamby Blvd, Springfield , QLD, 4300
Country [3] 282608 0
Australia
Other collaborator category [4] 282609 0
University
Name [4] 282609 0
Menzies Health Institute Queensland, Griffith University
Address [4] 282609 0
Griffith University, Nathan Campus, 170 Kessels Rd, Nathan, QLD, 4111
Country [4] 282609 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312738 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 312738 0
Griffith University, Nathan Campus, 170 Kessels Rd, Nathan, QLD, 4111
Ethics committee country [1] 312738 0
Australia
Date submitted for ethics approval [1] 312738 0
09/12/2022
Approval date [1] 312738 0
22/03/2023
Ethics approval number [1] 312738 0
GU Ref No: 2023/081

Summary
Brief summary
The current study aims to conduct a nation-wide, RCT of the efficacy of the multi-technology intervention that trains parents to be ‘ERP coaches’ for their children via four self-directed web-based modules and videoconference group sessions with a therapist (i.e., FAST-CBT: Families Accessing online Skills Training in CBT) relative to Waitlist Control (WLC) for children (4-12 years) with subclinical and clinical OCD. Primary outcomes include symptom severity, OCD-related impairment, family accommodation and cost effectiveness, assessed at post-treatment (2 month following baseline) and at the primary end point 6 months following treatment (FAST-CBT condition only). Diagnostic status over time will be examined to determine intervention effects and the prevention of clinical diagnoses (for sub-clinical children) at 6 months follow-up. Secondary aims will be to explore predictors of treatment response, including child age, OCD severity, co-morbid symptoms (internalising and externalising), and family functioning (accommodation, parental depression/ anxiety/stress, parenting practices/family functioning). Based on the primary aims, it is hypothesised that relative to WLC, FAST-CBT will: (a) be associated with significantly greater reductions in OCD severity, OCD-related impairment, and family accommodation at post-treatment and follow-up; (b) will result in significantly fewer sub-clinical children at baseline converging into clinical range at post and follow-up.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125730 0
Prof Lara J Farrell
Address 125730 0
School of Applied Psychology, Griffith University, Gold Coast Campus, 1 Parkland Drive,
Southport, QLD 4215
Country 125730 0
Australia
Phone 125730 0
+61 7 5678 8224
Fax 125730 0
Email 125730 0
l.farrell@griffith.edu.au
Contact person for public queries
Name 125731 0
Prof Lara J Farrell
Address 125731 0
School of Applied Psychology, Griffith University, Gold Coast Campus, 1 Parkland Drive,
Southport, QLD 4215
Country 125731 0
Australia
Phone 125731 0
+61 7 5678 8224
Fax 125731 0
Email 125731 0
l.farrell@griffith.edu.au
Contact person for scientific queries
Name 125732 0
Prof Lara J Farrell
Address 125732 0
School of Applied Psychology, Griffith University, Gold Coast Campus, 1 Parkland Drive,
Southport, QLD 4215
Country 125732 0
Australia
Phone 125732 0
+61 7 5678 8224
Fax 125732 0
Email 125732 0
l.farrell@griffith.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Consent for this will not be obtained from participants


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.