Feasibility of a randomised controlled trial to compare an adapted online parent-led treatment to treatment as usual for preadolescent children with obsessive compulsive disorder (OCD)
Specialty: Mental Health, Primary sub-specialty: Personality disorder - OCD; Health Category: Mental health; Disease/Condition: Neurotic, stress-related and somatoform disorders
Families taking part in the study will be randomly assigned to one of two groups: either the OSI for OCD intervention or treatment as usual (TAU) within mental health services that provide treatment on behalf of the NHS. Stratified randomisation will be conducted using a web-based randomisation tool designed for clinical trials and research studies to ensure balance across key variables, including: Child’s age (e.g., ≤8 years; >8 years), Gender and OCD symptom severity (measured by baseline CY-BOCS scores). We will use a randomisation tool that operates through a secure online platform, accessible only to authorised study personnel. Participants will be randomly assigned to either the OSI for OCD (n=24) or treatment as usual (TAU) arms (n=24), within one month of completing baseline assessments. Families allocated to the OSI for OCD treatment will be added to the online intervention platform by the research team, from which they can start their treatment, with therapist support. This includes completing 10 online modules, with 10 x 20-30 minute phone calls (including 8 therapist sessions, and 2 check-ins). For families in the OSI for OCD group, routine outcome measures (ROMs) that are collected as part of this treatment will also be available to the research team. OSI treatment lasts for approximately 4 months. Families assigned to TAU will receive their usual care, and information on the nature of this treatment will be collected from therapists and supervision logs. Parents and children will be invited to complete post-treatment and follow-up questionnaires and interviews online at 20 and 32 weeks after randomisation. To address researcher bias, outcome assessors, who will conduct the diagnostic and clinical assessments, will be blinded to the treatment allocation of participants. This is to ensure that data collection for primary and secondary outcomes remains unbiased. Note. The research team will call all families to let them know the outcomes of the ADIS-C
1. Child has been diagnosed with OCD on the basis of the ADIS-C or ADIS-P by the research team. 2. Parent/carer is willing and able to give informed consent for participation in the study on behalf of their child and themselves. 3. Child is willing and able to give informed assent for participation in the study. 4. Child aged 5–12 years. 5. Child has been referred to services that provide psychological support for child mental health problems on behalf of the NHS. 6. Child and parent/carer are able to understand, read, and communicate in English. 7. Parent/carer is willing and able to engage with the online intervention platform (OSI) if randomised to the OSI for OCD treatment arm. 8. Parent/carer is willing and able to complete required assessments.
1. The child is currently receiving any other psychological intervention. 2. The child is receiving psychotropic medication and the dose has not been stable for at least two months. 3. The child has a confirmed or likely diagnosis of autism (indicated by a score > 15 on the Social Communication Questionnaire-lifetime version). 4. If the child has profound learning difficulties evidenced by attending a specialist school. 5. If there are risk and/or safeguarding concerns which are paramount and would interfere with treatment delivery, including suicidal intention, recurrent or potentially life-limiting self-harm, or if the child has a child protection plan/is on the child protection register/the research team consider the child to be suffering, or likely to suffer, significant harm. 6. Parent/carer or child is unable to understand, read, or communicate in English, which would prevent meaningful participation in the intervention or assessments. 7. The child is referred to a clinical team where the only usual treatment option is the University of Oxford’s face-to-face/telephone version of brief therapist guided, parent-led CBT for OCD