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Trial registered on ANZCTR


Registration number
ACTRN12625000117415p
Ethics application status
Submitted, not yet approved
Date submitted
12/09/2024
Date registered
3/02/2025
Date last updated
3/02/2025
Date data sharing statement initially provided
3/02/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot Study of a Mental Health Intervention for children and adults with Developmental & Epileptic Encephalopathies (DEEs)
Scientific title
Pilot Study of a Mental Health Intervention to diagnose and treat psychological and behavioural disorders in children and adults with Developmental & Epileptic Encephalopathies.
Secondary ID [1] 312939 0
MRF2032010
Universal Trial Number (UTN)
Trial acronym
MICE-DEE
Linked study record
This study is related to registration record ISRCTN57823197. This protocol has been modified to treat a more severe population of children and adults with Developmental and Epileptic Encephalopathies. The study coordinators for registration record ISRCTN57823197 are associate investigators for this trial.

Health condition
Health condition(s) or problem(s) studied:
Developmental and Epileptic Encephalopathy 335105 0
behavioural disorders 335107 0
psychological disorders 335106 0
Condition category
Condition code
Neurological 331607 331607 0 0
Epilepsy
Mental Health 331608 331608 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 329471 0
Behaviour
Intervention code [2] 329470 0
Treatment: Other
Comparator / control treatment
Arm 1: Assessment-Enhanced Standard Care. Participants randomised to this arm will complete the Development and Wellbeing Assessment (DAWBA), and not receive active intervention. The DAWBA diagnosis will be provided to the referring clinician who can use the results to refer the patient for further management if indicated.
Control group
Active

Outcomes
Primary outcome [1] 339346 0
Rate of recruitment and completion.
Assessment method [1] 339346 0
The intervention will be considered feasible if 80% of the total randomised cohort (N=80), including both intervention and control arms, complete the trial and provide outcome data.
Timepoint [1] 339346 0
Baseline, 6 months, and 12 months post-randomisation.
Secondary outcome [1] 439608 0
To estimate the effect size of the intervention efficacy of the MICE-DEE intervention for children and adults with DEEs and mental health disorders, compared with assessment enhanced standard care.
Assessment method [1] 439608 0
The effect size of the difference in the Developmental Behaviour Checklist (DBC-2) Total problems Score from baseline to 6-months post-randomization amongst those randomised to the MICE-DEE intervention compared to assessment enhanced standard care controls.
Timepoint [1] 439608 0
Baseline, 6 months and 12 months post-randomisation.

Eligibility
Key inclusion criteria
Age 4 years or older
Diagnosis of a DEE
Scored above pre-specified threshold on the DBC-2 for mental health symptoms
Meeting DSM-5 or ICD-10 diagnostic criteria for a mental health disorder (eg. depression, anxiety, disruptive behaviour or trauma)
Have a parent or regular carer of normal intellect willing to participate in MICE-DEE
Minimum age
4 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Insufficient English to access screening measures
Refusing to have therapy sessions audio and/or video recorded
Actively receiving psychological therapy to treat emotional or behavioural problems at time of initial assessment or intervention phase
Presence of active, severe mental health disorder requiring immediate intervention and not suitable for MICE intervention (eg. psychosis, active suicidal ideation).
Unable to complete the measures despite all reasonable efforts being made to assist

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)
Central randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients meeting all inclusion criteria will be assigned a unique screening number after informed consent is obtained. Then, a sequential randomisation number within the REDCap eCRF will be generated directing patients to either Arm 1 or Arm 2 stratified by age (4-17, >18 years). This will be followed by within stratum use of covariate adaptive randomisation via the minimum sufficient balance method that considers the following parameters: intellectual disability severity based on the results of the Vineland-3 (mild-moderate 36-69; severe-profound 1-35), primary mental health diagnosis (anxiety, depression, disruptive behaviour), and ASD diagnosis (yes/no).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary outcome of feasibility of the MICE-DEE intervention will be assessed by recruitment rates, retention rates and time needed per patient for the study. Outcome data will be presented in terms of mean, median, standard deviations, and range. No formal statistical analyses are planned for the assessment of feasibility for the primary outcome analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/02/2025
Actual
Date of last participant enrolment
Anticipated
2/02/2027
Actual
Date of last data collection
Anticipated
2/02/2028
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 27086 0
The Royal Childrens Hospital - Parkville
Recruitment hospital [2] 27087 0
Sydney Children's Hospital - Randwick
Recruitment hospital [3] 27085 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [4] 27089 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [5] 27088 0
The Children's Hospital at Westmead - Westmead

Funding & Sponsors
Funding source category [1] 317374 0
Government body
Name [1] 317374 0
Department of Health and Aged Care: Medical Research Future Fund: 2023 MRFF Clinician Researchers - Applied Research in Health
Country [1] 317374 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Country
Australia
Secondary sponsor category [1] 319667 0
None
Name [1] 319667 0
Country [1] 319667 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316103 0
The Royal Children’s Hospital Human Research Ethics Committee
Ethics committee address [1] 316103 0
Ethics committee country [1] 316103 0
Australia
Date submitted for ethics approval [1] 316103 0
28/10/2024
Approval date [1] 316103 0
Ethics approval number [1] 316103 0

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 136790 0
Prof Ingrid E Scheffer
Address 136790 0
Level 2, Melbourne Brain Centre, 245 Burgundy Street, University of Melbourne, Heidelberg VIC 3084
Country 136790 0
Australia
Phone 136790 0
+61 3 9035 7112
Email 136790 0
scheffer@unimelb.edu.au
Contact person for public queries
Name 136791 0
Marie Inder
Address 136791 0
Level 2, Melbourne Brain Centre, 245 Burgundy Street, University of Melbourne, Heidelberg VIC 3084
Country 136791 0
Australia
Phone 136791 0
+61 3 9035 7228
Email 136791 0
marie.inder@unimelb.edu.au
Contact person for scientific queries
Name 136792 0
Ingrid E Scheffer
Address 136792 0
Level 2, Melbourne Brain Centre, 245 Burgundy Street, University of Melbourne, Heidelberg VIC 3084
Country 136792 0
Australia
Phone 136792 0
+61 3 9035 7112
Email 136792 0
scheffer@unimelb.edu.au

Data sharing statement
Will the study consider sharing individual participant data?
No


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.