EpilepsyAWE-ChangeNCT05660239
Impact of a Community Based Engagement Program Focused on Adolescents With Epilepsy
A study testing Community Intervention in people with Epilepsy, run by Makerere University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- What is being tested?
- Community Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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:
Read more
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.
Read the 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.
- Conditions
- Epilepsy
- Being tested
- Community Intervention
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community InterventionOther
To evaluate the impact of a community intervention in reducing epilepsy stigma in adolescents.
| Study group | Role | What they receive |
|---|---|---|
| Wakiso district-Urban Parish | Other | 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. Receives: Other: Community Intervention |
| Wakiso district-Rural Parish | Other | 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. Receives: Other: Community Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attitudes and Beliefs about Living with Epilepsy (ABLE) scores among the community stigma reduction implementation team.
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)
Measured: two years
Attitudes and Beliefs about Living with Epilepsy (ABLE) scores among the non-community stigma reduction implementation team.
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).
Measured: two years
Kilifi Stigma Scale scores among adolescents with epilepsy
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.
Measured: two years
Quality of Life for Epilepsy in Adolescents scores
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).
Measured: two years
Secondary outcomes (2)
Beck Youth Inventory for depression (BDI-Youth) scores among adolescents with epilepsy
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).
Measured: two years
Columbia Suicide Severity Rating Scale (C-SSRS) scores for the adolescents living with epilepsy.
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.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study startMar 2024 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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, pre and post the implementation of the community change projects in two parishes (urban and rural) to see if there is improvement in these assessments scores.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Duke University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05660239
- Sponsor's protocol ID
- 1R01HD106277-01
- Other IDs
- R01HD106277
- Acronym
- AWE-Change
- Status last verified
- Aug 2023
- First submitted
- 7 Dec 2022
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epilepsy in Uganda: Clinical Characterization and Co-morbidities, Their Relation to Stigma Among Adolescents and Impact of a Community-based Engagement Program
- ClinicalTrials.gov ID
- NCT05660239
- Acronym / sponsor ID
- AWE-Change / 1R01HD106277-01
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Duke University
- Study start
- Mar 2024 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 21 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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, pre and post the implementation of the community change projects in two parishes (urban and rural) to see if there is improvement in these assessments scores.
| Arm | Type | Receives |
|---|---|---|
| Wakiso district-Urban Parish | Other | Other: Community InterventionStudy 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. |
| Wakiso district-Rural Parish | Other | Other: Community InterventionStudy 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. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community InterventionTo evaluate the impact of a community intervention in reducing epilepsy stigma in adolescents. | Other | Wakiso district-Rural Parish, Wakiso district-Urban Parish |
Primary outcome
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)
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).
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.
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).
2 secondary outcomes
Beck Youth Inventory for depression (BDI-Youth) scores among adolescents with epilepsy
Time frame: two years
Columbia Suicide Severity Rating Scale (C-SSRS) scores for the adolescents living with epilepsy.
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Community Intervention in people with Epilepsy, run by Makerere University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attitudes and Beliefs about Living with Epilepsy (ABLE) scores among the community stigma reduction implementation team. (time frame: two years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2023.