Impact of a Community Based Engagement Program Focused on Adolescents With Epilepsy (AWE-Change)

August 30, 2023 updated by: Makerere University

Epilepsy in Uganda: Clinical Characterization and Co-morbidities, Their Relation to Stigma Among Adolescents and Impact of a Community-based Engagement Program

The goal of this community based observation study is to co-create solutions that empower people to make informed decisions about epilepsy, reduce stigma, and promote community health among the adolescent population living with epilepsy in Uganda.

The main objectives of the study are to:

Goal 1: Co-create a unique patient-community engagement program (CEP) to reduce stigma on epilepsy among adolescents and their caregivers in Uganda based on understanding of the illness.

Goal 2: Evaluate the impact of this CEP to reduce stigma on epilepsy among adolescents and their caregivers in Uganda, based on understanding of the illness.

Study participants together with the relevant community stakeholders will co-design feasible communication and activity-based change projects that are based on both cultural and scientific norms, to reduce epilepsy stigma in the community Researchers will then compare the Quality of Life, Attitudes and Beliefs about Living with Epilepsy scores (as a surrogate of stigmatizing beliefs and practices among community members) and the Kilifi Stigma Scale scores in two parishes (urban and rural) to see if there is improvement in these assessments scores following the implementation of the community change projects.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Study Site:

The study will be conducted in Wakiso District which lies in the Central region of Uganda with a target adolescent group (ages 10-18) comprising ~22% of the population. Wakiso District has the largest population density and a 7% growth rate. Our previous epilepsy prevalence work also showed it had the highest number of adolescents with epilepsy (AWE). Wakiso also offers the advantage of having both rural communities similar to those in more remote areas of the country, as well as rapidly expanding urban communities as seen in other urban centers like Kampala city, the capital.

Selecting the communities for intervention:

Two Wakiso district divisions will be randomly selected from enumerated divisions. Within these, parishes will be enumerated and divided into urban and rural parishes, from which one rural and one urban will be randomly selected. The investigators will then list the villages within each selected parish and randomly select two adjacent villages per parish. Using Objective 1 records, the investigators will contact AWE (ages 10-18) and their caregivers in these villages for invitation to the CEP, and the investigators will repeat this step as needed until the required number is obtained.

Study Implementation:

Step 1: a) Evaluate tacit knowledge and values of community stakeholders. Methods: focus groups discussions (FGDs), in depth interviews, and social media discussions with community leaders, clergy, traditional healers, teachers, and any people who are agents of progression and change. For the in depth interviews the investigators plan to engage 20-40 stakeholders, while for the focus group discussions about 10-20, the stakeholders will be categorized according to their gender and respective age groups in groups of 6-8 individuals per FGD until data saturation is achieved. b) Obtain baseline Attitudes and Beliefs about Living with Epilepsy (ABLE) scale scores. c) Select the stigma reduction implementation team (SRIT)- this will involve a smaller group of participants, called the SRIT, composed of patient champions (AWE and/or their caregivers; n=5-10), community champions (n=5-10), and members of the research team will convene to plan communication and activity-based change solutions that are based on both cultural and scientific norms of all stakeholders. This participatory approach to problem solving is a proven method to optimize change management.

Step 2: Enhance and refine epilepsy knowledge within the SRIT by cultivating shared culturally and scientifically informed perspectives. With identification of key areas of concern regarding epilepsy stigma, communities and other stakeholders of epilepsy for example Epilepsy Support Association, Uganda (ESAU) or Purple Bench Initiative will also be engaged in various dialogue forms to identify solutions to the issues identified.

Step 3: Co-create strategies for paradigm change; select most promising projects. These culturally and scientifically informed solutions may involve several communication venues, such as packaging messages in poems/songs/drama skits to be delivered through technology-based approaches such as social media, use of social network sites, text messaging, podcasts, blogs, and/or YouTube videos. The SRIT will analyze the merit of all proposed solutions and rank them according to potential for meeting the goals of the engagement within resource guidelines. This ensures investment in the innovative problem-solving practices as utilizing self-management and positive reinforcement within the impacted community. Four full prototypes will be co-created and co-designed to reduce stigma. Two knowledge cycles will inform the development and refinement of the projects to facilitate engagement and new norms Step 4: Implement unique SRIT change projects in the community, monitor project progress for adjustment.

After Cycle 1, progress is jointly evaluated from all stakeholder perspectives, projects are refined or replaced, and Cycle 2 is initiated to impact social change through re-engaging the broad community.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 14 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Study Population

Target population:

All adolescents with epilepsy, aged 10-18 years and their caregivers residing in Wakiso district, Uganda

Accessible population:

Adolescents with epilepsy, aged 10-18 years and their caregivers residing in the selected urban and rural parishes of Wakiso district during the study period.

Description

Inclusion Criteria:

Adolescent with epilepsy residing in Wakiso district

  • Between the ages 10-18 years
  • A resident of Wakiso district, Uganda for the previous six months
  • Confirmed diagnosis for epilepsy as per the International League Against Epilepsy definition
  • Provide written assent to participation in the study
  • With a caregiver willing to provide written informed consent as well as detailed history regarding them.
  • Willing to participate in all the required program activities with his/her caregiver

Exclusion Criteria:

Adolescent with epilepsy residing in Wakiso district who

  • Does not have the time or interest to participate in the community engagement program
  • Has had exposure to a similar previous community engagement program
  • Is unable to fully understand what is required of him/her in the study and engage consistently throughout the whole community engagement program

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Wakiso district-Urban Parish

Study participants together with the relevant community stakeholders will co-design feasible communication and activity-based change projects that are based on both cultural and scientific norms, to reduce epilepsy stigma in the community.

Researchers will then compare the Quality of Life, Attitudes and Beliefs about Living with Epilepsy scores and the Kilifi Stigma Scale scores following the implementation of the community change projects in an urban parish to see if there is improvement in these assessments scores.
Other: Community Intervention
To evaluate the impact of a community intervention in reducing epilepsy stigma in adolescents.
Other: Wakiso district-Rural Parish

Study participants together with the relevant community stakeholders will co-design feasible communication and activity-based change projects that are based on both cultural and scientific norms, to reduce epilepsy stigma in the community.

Researchers will then compare the Quality of Life, Attitudes and Beliefs about Living with Epilepsy scores and the Kilifi Stigma Scale scores following the implementation of the community change projects in a rural parish to see if there is improvement in these assessments scores.
Other: Community Intervention
To evaluate the impact of a community intervention in reducing epilepsy stigma in adolescents.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Attitudes and Beliefs about Living with Epilepsy (ABLE) scores among the community stigma reduction implementation team.
Time Frame: two years
Change in knowledge, attitude and beliefs regarding epilepsy among the community stigma reduction implementation team. Attitudes and Beliefs about Living with Epilepsy (ABLE) scale, are scored on a five-point Likert scale (1=no stigma, 5=high stigma)
two years
Attitudes and Beliefs about Living with Epilepsy (ABLE) scores among the non-community stigma reduction implementation team.
Time Frame: two years
Change in knowledge, attitude and beliefs regarding epilepsy among the non-community stigma reduction implementation team. Attitudes and Beliefs about Living with Epilepsy (ABLE) scale, are scored on a five-point Likert scale (1=no stigma, 5=high stigma).
two years
Kilifi Stigma Scale scores among adolescents with epilepsy
Time Frame: two years
Change in perceived stigma for the adolescents living with epilepsy. Kilifi Stigma scale has a three-point Likert scoring, (0 = not at all, 1 = sometimes, 2 = always). A total score is calculated by addition of all item scores. The higher the score, the greater the sense of perceived stigma.
two years
Quality of Life for Epilepsy in Adolescents scores
Time Frame: two years
Change in the quality of life for the adolescents living with epilepsy. Quality of Life(QoL) for Epilepsy in Adolescents scores are on a 5-point Likert scale with: 1 = poor; and 5 = excellent. Ratings are linearly transformed, providing total scores from 0 (low QoL) to 100 (high QoL).
two years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Beck Youth Inventory for depression (BDI-Youth) scores among adolescents with epilepsy
Time Frame: two years
Change in the depression severity among adolescents with epilepsy.Beck Youth Inventory for depression (BDI-Youth) raw scores are translated into T-scores assigned by age and gender as follows ( 55 or less = average ; 70+ = extremely elevated).
two years
Columbia Suicide Severity Rating Scale (C-SSRS) scores for the adolescents living with epilepsy.
Time Frame: two years

Change in the suicide severity among adolescents with epilepsy. There are no specified clinical cutoffs for the Columbia-Suicide Severity Rating Scale due to the binary nature (yes/no) of the responses to 10 category items. Composite endpoints based on the categories as follows:

Suicidal ideation: A "yes" answer at any time during treatment to any one of the five suicidal ideation questions (Categories 1-5) on the Columbia-Suicide Severity Rating Scale.

Suicidal behavior: A "yes" answer at any time during treatment to any one of the five suicidal behavior questions (Categories 6-10) on the Columbia-Suicide Severity Rating Scale.

Suicidal ideation or behavior: A "yes" answer at any time during treatment to any one of the ten suicidal ideation and behavior questions (Categories 1-10) on the Columbia-Suicide Severity Rating Scale.
two years

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Makerere University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Duke University

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 7, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 21, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1R01HD106277-01 (U.S. NIH Grant/Contract)
  • R01HD106277 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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