An Exploratory RCT of a Psychosocial Group Intervention for Epilepsy (PIE)

January 23, 2015 updated by: NHS Greater Glasgow and Clyde

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Psychosocial group intervention
Behavioral: Psychosocial Intervention Group
6 group sessions
Other: Waiting List control
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
Treatment as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of the PIE group
Time Frame: Baseline
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
Time Frame: 6 weeks
6 weeks
Effectiveness of the PIE group
Time Frame: 3 months
3 months
Effectiveness of the PIE group
Time Frame: 6 months
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NHS Greater Glasgow and Clyde

Investigators

  • Principal Investigator: Liam Dorris, BSc (Hons), D.Clin.Psy, NHS Greater Glasgow and Clyde

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Anticipated)

April 1, 2016

Study Completion (Anticipated)

April 1, 2016

Study Registration Dates

First Submitted

January 19, 2015

First Submitted That Met QC Criteria

January 23, 2015

First Posted (Estimate)

January 29, 2015

Study Record Updates

Last Update Posted (Estimate)

January 29, 2015

Last Update Submitted That Met QC Criteria

January 23, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GN12KH157

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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