None listed
Conditions
Brief summary
This study aims to evaluate the feasibility, acceptability and efficacy of a new cognitive behavioral intervention designed to help children with epilepsy improve their social competence. The new intervention uses a number of non-invasive, child friendly techniques previously used with children with developmental disorders and typically developing children to teach children with epilepsy how to respond in social situations. The intervention is focused on development of perspective taking, which means understanding what another person is thinking (cognitive perspective taking) and feeling (affective perspective taking); also called theory of mind. We decided to focus our intervention on perspective taking, as it is a core social cognitive skill that is important for socialisation. Also, research has shown that children with epilepsy have marked difficulties perspective taking about thoughts and feelings of others, which affects their ability to respond in social situations. Children with epilepsy also have difficulty identifying and labelling their own thoughts and feelings, which is a precursor for knowing about the thoughts and feelings of others. This is the first intervention that addresses this critical area of clinical need. Social difficulties are frequent in children with epilepsy and have significant clinical implications including increased risk of anxiety, depression and ongoing social and emotional difficulties as adolescents and adults. This feasibility study will involve four face-to-face groups led by registered psychologists. The groups will involve role-plays, videos, social stories, group discussions, and paper and pen tasks. The groups will be held in clinical rooms designed for child and family therapy. The study will also involve four one-to-one assessments with a psychologist (15 to 35 minutes each) that will take place at baseline (4 to 6 weeks before the first day of the intervention), pre-treatment (first day of the intervention) post-treatment (last day of the intervention), and follow-up (4 to 6 weeks after the intervention has been completed). The assessments will involve paper and pen and computerized tasks. All tasks are similar to those that would be completed in a normal clinical setting. At no point during the study will children be exposed to activities that will pose undue physical or psychological strain. However, in the unlikely event a child becomes distressed, this will be sensitively managed by the psychologists running the groups.
Interventions
Brief name: Cognitive behavioural intervention for social perspective taking in children with epilepsy.
Materials. The intervention will be taught via a range of mediums including written social stories, cartoons, video vignettes, role-plays and paper and pen tasks, which are all outlined in the intervention workbooks. Separate workbooks have been created for children, parents and the investigators. Child workbooks contain activities designed to teach social perspective taking skills. Investiga
Brief name: Cognitive behavioural intervention for social perspective taking in children with epilepsy. Materials. The intervention will be taught via a range of mediums including written social stories, cartoons, video vignettes, role-plays and paper and pen tasks, which are all outlined in the intervention workbooks. Separate workbooks have been created for children, parents and the investigators. Child workbooks contain activities designed to teach social perspective taking skills. Investigator workbooks mirror the content of the child workbook, with additional scripts included for instruction and feedback. Parent workbooks contain a brief overview of skills taught to children and additional activities for the parent-child review sessions. Assessments with children will involve standardised behavioural tasks and questionnaires that assess ToM, social competence and overall treatment acceptability. Parents will complete standardised questionnaires assessing ToM, social competence, cognitive skills, overall treatment acceptability and barriers and facilitators to attendance. Independent clinicians will complete standardised questionnaires assessing barriers and facilitators to attendance and an attitudes and practice scale. All intervention materials can be accessed by contacting the lead author of the study. Procedures. Children will participate in 4 small group workshops and complete 4 one-to-one assessments with an investigator. Additional support will be provided to parents via weekly phone calls. These will be used to monitor progress and assist parents with helping their child implement skills. Upon completion of the study, parents and children will attend individual face-to-face debriefing sessions and complete online questionnaires assessing treatment acceptability and barriers and facilitators to attending the program. Providers. Intervention sessions will be led by psychologists who hold general registration with the Psychology Board of Australia and have experience working with children with and without epilepsy. Diagnoses of epilepsy will be confirmed by treating neurologists. Modes of delivery. The intervention will involve face-to-face groups, which children will participate in with 1 to 5 other children who are a similar age and have a diagnosis of epilepsy. Assessments will take place in a one-to-one face-to-face format with an investigator. Parents will complete questionnaires online. Frequency and duration. The intervention will involve 4 small group workshops, held weekly over 4 consecutive weeks. Each workshop will contain 2 to 3 x 50-minute sessions, separated by 10 to 20 minute breaks. Children will attend these workshops without their parents. Parents will attend a 30-minute review session with their child at the end of each day. Assessments will take place at 4 time-points: baseline (4 to 6 weeks before treatment), pre-treatment (first day of intervention or up to 7 days prior), post-treatment (last day of intervention of up to 7 days after treatment has been completed), and follow-up (4 to 6 weeks after treatment). Child assessments will take 15 to 35 minutes. Questionnaires completed by parents will take 55 to 75 minutes. Two brief weekly measures will be taken from parents and children over the telephone, taking 1 to 5 minutes each. Location. The intervention sessions will be held at the Psychology Clinic at the University of Sydney. Assessments will take place at the Psychology Clinic or at participants’ homes. Weekly support and measures will be obtained over the telephone. Tailoring. The intervention follows a standardised program, as outlined in the child, parent and investigator workbooks. However, investigators will provide individualised support and feedback to families during the weekly phone calls. Adherence. Adherence is being assessed as one of the primary feasibility aims. Home-based catch up sessions will be provided in unavoidable circumstances where children miss a treatment session. These are being provided to decrease barriers to attendance and assist with completion of the program.
Sponsors
Associate Professor Suncica Lah
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
8 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
(i) A current diagnosis of genetic generalised epilepsy (GGE) or temporal lobe epilepsy (TLE) confirmed by treating neurologists (ii) Aged between 8 to 16 years old (iii) Fluency in the English language (iv) Assessed to have a full scale intellectual quotient (FSIQ) > 70 (v) Absence of major developmental/psychiatric conditions (i.e. autism), sensory/motor impairments (i.e. cerebral palsy, significant visual or hearing impairments), major neurological disorder (e.g. severe brain injury), systemic and metabolic disorders that could lead to cognitive impairment (vi) No clinical signs of drug intoxication/drug and alcohol abuse (viii) Absence of a neurological procedure/surgery in the past 3 months.
Exclusion criteria
(i) No longer meet criteria for GGE or TLE, as their epilepsy has been classified as ‘resolved’ by their treating neurologists. Epilepsy is considered resolved for individuals who had an age-dependent epilepsy syndrome but are now past the applicable age or those who have remained seizure-free for the last 10 years, with no seizure medicines for the last 5 years (Fisher et al. 2014) (ii) Have had a neurological procedure/surgery in the past 3 months. Fisher RS, Acevedo C, Arzimanoglou A, Bogacz A, Cross JH, Elger CE, et al. ILAE official report: a practical clinical definition of epilepsy. Epilepsia. 2014;55(4):475-82.
Outcome results
None listed