Clinical trial NCT02349529: An Exploratory RCT of a Psychosocial Group Intervention for Epilepsy
Official title: An Exploratory Randomised Controlled Trial of a Manualised Psychosocial Group Intervention for Young People With Epilepsy (PIE)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Epilepsy
Keywords: Epilepsy
psychosocial
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
First posted: 2015-01-29
Enrollment: 200
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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:

  1. Postnatally acquired structural lesions (e.g. TBI or neurooncological conditions)
  2. Immune mediated disorders (e.g. limbic or antiNMDAR encephalopathy)
  3. Metabolic disorders (e.g. GLUT1 deficiency)

Primary outcomes:
measure: Effectiveness of the PIE group
timeFrame: Baseline
measure: Effectiveness of the PIE group
timeFrame: 6 weeks
measure: Effectiveness of the PIE group
timeFrame: 3 months
measure: Effectiveness of the PIE group
timeFrame: 6 months
Secondary outcomes:
measure: The Paediatric Index of Emotional Distress (PIED).
timeFrame: Baseline, 6 weeks, 3 months and 6 months
measure: The Seizure Self Efficacy Scale for Children (SSEC)
timeFrame: Baseline, 6 weeks, 3 months and 6 months
measure: Epilepsy Knowledge ProfileGeneral (EKPG)
timeFrame: Baseline, 6 weeks, 3 months and 6 months
measure: Brief Illness Representations Questionnaire (BIPQ).
timeFrame: Baseline, 6 weeks, 3 months and 6 months
measure: Participant social functioning
timeFrame: Baseline, 6 weeks, 3 months and 6 months
measure: seizure control
timeFrame: Baseline, 6 weeks, 3 months and 6 months
Other outcomes:
Locations:
Study officials:
affiliation: NHS Greater Glasgow and Clyde
name: Liam Dorris, BSc (Hons), D.Clin.Psy
role: PRINCIPAL_INVESTIGATOR
References: