An Exploratory RCT of a Psychosocial Group Intervention for Epilepsy

NCT02349529 | Unknown

• 1 other identifier: GN12KH157
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Epilepsy

Keywords

Epilepsy; psychosocial

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• 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

Study Arms (2)

Psychosocial group intervention

EXPERIMENTAL

Behavioral: Psychosocial Intervention Group

Waiting List control

OTHER

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

Interventions

Psychosocial Intervention Group BEHAVIORAL

6 group sessions

Psychosocial group intervention

Waiting list control OTHER

Treatment as usual

Waiting List control

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Liam Dorris, BSc (Hons), D.Clin.Psy

  NHS Greater Glasgow and Clyde

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liam Dorris, BSc (Hons), D.Clin.Psy

CONTACT

01412010638; liam.dorris@ggc.scot.nhs.uk

Helen Broome, BSc (Hons), D.Clin.Psy

CONTACT

01412010638; helen.broome@ggc.scot.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2015
• First Posted: January 29, 2015
• Study Start: February 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: January 29, 2015

Record last verified: 2015-01