Pilot Study of a Mental Health Intervention for children and adults with Developmental & Epileptic Encephalopathies (DEEs)

Pilot study of a Mental Health Intervention for Children and Adults with DEEs (MICE-DEE). Our UK collaborators used MATCH-ADTC (Modular Approach to Therapy for Children with Anxiety, Depression, Trauma or Conduct problems) in children with epilepsy. MATCH-ADTC is based on principles of cognitive behavioural therapy (CBT) for behaviour problems, anxiety, depression, and trauma. Their intervention, MICE (Mental health Intervention for Children with Epilepsy), modified MATCH-ADTC by incorporating additional modules for use with children with epilepsy, including those with mild intellectual disability. Study design: Children (4+ years) and adults with DEEs and mental health disorders will be randomised to either Assessment-Enhanced Standard Care for 26 weeks, or MICE-DEE, a personalized modular psychological therapy, for 16 (±6, minimum of 10) sessions for 26 weeks. This intervention will be delivered entirely to caregivers of normal intellect. Individuals with DEEs will often have severe or profound intellectual disability and will not be able, or asked, to engage in telehealth. The caregivers will attend weekly sessions with the MICE-DEE therapist to develop and practice strategies to ameliorate their child’s mental health problem. Caregivers will then practice these strategies at home and complete weekly check-in measures before each session. The participants will gain access to the MICE-DEE trial via an initial psychological intervention assessment with parents conducted face-to-face where possible. The remaining trial will be delivered by telehealth (zoom or telephone). The intervention will be provided by therapists trained in the MICE-DEE intervention. The MICE-DEE therapists will come from a range of disciplines, including psychologists, epilepsy nurse specialists, mental health workers, research personnel and clinicians. MICE-DEE therapists will receive regular clinical supervision with clinical psychologists or neuropsychologists. The MICE-DEE trial involves a weekly consultation using telehealth. Parents/carers will practise intervention strategies at home and complete weekly check-in measures via email before each session with the therapist. MICE-DEE involves an average of 16 sessions (minimum 10, maximum 22 sessions), within 6 months post-randomisation, with two booster sessions permitted between 6 and 12 months. The time to complete each session is approximately 1 hour, each module involves an average of 16 sessions. Modules included in the MICE-DEE trial include behavioural problems, depression, and anxiety. Each module contains practices: example practices within the ‘behaviour problems’ treatment module include time out, rewards, active ignoring, making a plan, and effective instructions. Each practice is delivered via a 1-hour treatment session that involves psychoeducation and guided practice of therapeutic strategies between the participant and therapist, with homework tasks and additional practice completed outside each session. Strategies to assess adherence to the intervention are incorporated into the weekly consultation using telehealth and completion of the check-ins prior to the consultation. The weekly questionnaires include a parental self-efficacy scale to assess perceived effectiveness in delivering the intervention. The individualised intervention will be tailored to each patient, taking into account the main mental health problem. This will occur depending on the diagnosis determined following completion of the Developmental Behaviour Checklist (DBC-2) and Development and Wellbeing Assessment (DAWBA) assessments. Patients will then be randomised in the pilot study and the appropriate module assigned depending on the diagnoses. Changes in the default treatment sequence are accommodated to address treatment difficulties (eg. when outcome measures collected each week show a poor response), or immediate issues arising during treatment (eg. behavioural escalation) to enable real-time adaptation of the treatment protocol to address the key issue, before recommencing the main problem focus. Clinical judgement will be used throughout to determine whether adaptation to the default treatment sequence for the main mental health problem is required.