A novel cognitive behavioural intervention with Theory of Mind (ToM) training for children with epilepsy : Protocol for a case series feasibility study

Background
Children with epilepsy have significant social impairments, yet evidence-based interventions to address these social difficulties are lacking. Emerging research has shown that social difficulties in children with epilepsy relate to underlying impairments in Theory of Mind (ToM). This paper outlines the protocol for a pilot study that will evaluate the feasibility, acceptability, and efficacy of a novel cognitive behavioural intervention with ToM training for children with epilepsy.

Methods
The intervention will be evaluated in a single-arm case series feasibility study. Ten to 12 children with common forms of epilepsy (8 to 12 years old) will be recruited to participate in 4 small group workshops, held over 4 consecutive weeks. Parents will attend a brief review at the end of each session with their child. Children will complete 4 one-to-one assessments with an investigator assessing ToM and social competence: twice at baseline (4 weeks and 1 day before the intervention), at post-intervention (last day of the intervention) and at follow-up (4 weeks post intervention). Parents will complete online questionnaires at these same 4 time points assessing ToM and social competence of their child. Parents and children will both complete a weekly measure of social competence from baseline 1 to follow-up. Following completion of the intervention, parents will complete two standardised questionnaires assessing treatment acceptability and barriers and facilitators to attendance; children will complete a single questionnaire on treatment acceptability. Information about feasibility outcomes (i.e. recruitment and retention, processing time, suitability of tasks) will be gathered by investigators during the trial. Together, outcomes will be used to refine research methods and make a decision about whether the intervention should be evaluated in a larger scale trial.

Discussion
To our knowledge, this is the first psychosocial intervention to address social competence problems in children with epilepsy. Findings will provide information about a potentially effective treatment that could improve longer term social outcomes for this group.

Trial registration
Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12618000974202, registered June 8 2018.