An Exploratory RCT of a Psychosocial Group Intervention for Epilepsy

Study Overview
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Brief Summary
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Children and young people with epilepsy are at increased risk of poorer outcomes related to emotional and psychological adjustment, peer relationship problems, lower academic attainment and mental health problems across the lifespan. Despite the well understood risks, there continues to be a lack of psychological and psychosocial support for young people with epilepsy, and a corresponding lack of evidence regarding the effectiveness of psychosocial interventions. This study aims to evaluate a manualised psychosocial group intervention for adolescents with epilepsy. A cognitive behaviour therapy approach is used, aimed at increasing awareness of how epilepsy may impact upon thoughts, feelings and activities and to develop strategies for improved psychological adjustment. In addition, an epilepsy knowledge component aimed at improving a sense of control and epilepsy self-management is included. A group delivery format allows an opportunity for social modelling, and social problem solving, helping others and relating to other young people with similar experiences. The social learning context and availability of knowledgable facilitators (an epilepsy nurse specialist and clinical psychologist) are also key aspects of the intervention. The study will allow us to establish a standard manualised group intervention that can be used throughout the UK which aims to; establish the effectiveness and desirability of this approach; improve the overall quality of life, psychological health and social integration of young people with epilepsy; and to improve epilepsy knowledge and selfmanagement skills aimed at maximising seizure control and overall management.

Official Title
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An Exploratory Randomised Controlled Trial of a Manualised Psychosocial Group Intervention for Young People With Epilepsy (PIE)

Conditions
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Epilepsy

Intervention / Treatment
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* Behavioral: Psychosocial Intervention Group
* Other: Waiting list control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent Diagnosis of epilepsy (controlled or refractory) of at least 6 months duration Between the ages of 1217 years old Have a reasonable level of expressive and receptive English language abilities to enable them to fully participate and contribute to the group process In mainstream schooling. Exclusion Criteria: Formal diagnosis of Learning Disability or attendance at a school for children with Special Educational Needs Complex and severe mental health problems; Diagnosis of nonepileptic seizures in the absence of epileptic seizures Epilepsies occurring in the context of: Postnatally acquired structural lesions (e.g. TBI or neurooncological conditions) Immune mediated disorders (e.g. limbic or antiNMDAR encephalopathy) Metabolic disorders (e.g. GLUT1 deficiency)

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psychosocial group intervention<br> | Behavioral: Psychosocial Intervention Group<br>* 6 group sessions<br>|
| Other: Waiting List control<br>Participants in the waiting list control will continue in TAU but will then start the intervention once the first group of participants have completed the 3 month follow up in the psychosocial group intervention arm. | Other: Waiting list control<br>* Treatment as usual<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of the PIE group | Comparing participant's quality of life at baseline, completion of intervention, and at 3 and 6 month post group completion, as measured via the GEOSYP and PedsQL | Baseline | 
| Effectiveness of the PIE group |  | 6 weeks | 
| Effectiveness of the PIE group |  | 3 months | 
| Effectiveness of the PIE group |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Paediatric Index of Emotional Distress (PIED). |  | Baseline, 6 weeks, 3 months and 6 months | 
| The Seizure Self Efficacy Scale for Children (SSEC) |  | Baseline, 6 weeks, 3 months and 6 months | 
| Epilepsy Knowledge ProfileGeneral (EKPG) |  | Baseline, 6 weeks, 3 months and 6 months | 
| Brief Illness Representations Questionnaire (BIPQ). |  | Baseline, 6 weeks, 3 months and 6 months | 
| Participant social functioning |  | Baseline, 6 weeks, 3 months and 6 months | 
| seizure control |  | Baseline, 6 weeks, 3 months and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epilepsy, psychosocial