RecruitingACTRN12623000477628

Families Accessing online Skills Training in Cognitive Behaviour Therapy (FAST-CBT) for Paediatric Obsessive Compulsive Disorder (OCD): A nationwide randomised controlled trial

The Effect of FAST-CBT on paediatric OCD symptom severity, impairment and quality of life: A nationwide randomised controlled trial


Sponsor

Griffith Centre for Mental Health and Griffith University School of Applied Psychology, Griffith University

Enrollment

90 participants

Start Date

May 15, 2023

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 4 YearssMax Age: 12 Yearss

Plain Language Summary

Simplified for easier understanding

Obsessive-compulsive disorder (OCD) in children often involves intrusive, unwanted thoughts that cause significant anxiety, along with repetitive rituals or 'checking' behaviours that provide temporary relief. The standard treatment is a type of therapy called Exposure and Response Prevention (ERP), but access to trained therapists — especially for younger children — can be very limited. The FAST-CBT program is an innovative approach that trains parents to become 'ERP coaches' for their children aged 4–12. The program is delivered entirely online through four self-directed web modules and group video sessions with a therapist. This nationwide trial will compare outcomes for families who access FAST-CBT against those placed on a waitlist. Researchers are looking at whether the program reduces OCD symptoms, distress, and family accommodation (when family members change their routines to avoid triggering a child's anxiety). Your child may be eligible if they are aged 4–12 and have OCD symptoms or a confirmed diagnosis. If your child is currently taking medication for OCD or anxiety, the dose must have been stable for at least 8 weeks. Children with autism (levels 2–3), psychosis, or significant cognitive disability are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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. S

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.


Locations(1)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC, Australia

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ACTRN12623000477628


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