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Impact of a Community Based Engagement Program Focused on Adolescents With Epilepsy

Studies

Study First Submitted Date 2022-12-07
Study First Posted Date 2022-12-21
Last Update Posted Date 2022-12-21
Start Month Year March 2024
Primary Completion Month Year March 2026
Verification Month Year December 2022
Verification Date 2022-12-31
Last Update Posted Date 2022-12-21

Detailed Descriptions

Sequence: 20649198
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

Sequence: 51983761
Name Epilepsy
Downcase Name epilepsy

Id Information

Sequence: 40012625 Sequence: 40012626
Id Source org_study_id Id Source secondary_id
Id Value 1R01HD106277-01 Id Value R01HD106277
Id Type U.S. NIH Grant/Contract Id Type U.S. NIH Grant/Contract
Id Link https://reporter.nih.gov/quickSearch/1R01HD106277-01 Id Link https://reporter.nih.gov/quickSearch/R01HD106277

Design Groups

Sequence: 55386016 Sequence: 55386017
Title Wakiso district-Urban Parish Title Wakiso district-Rural Parish
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 following the implementation of the community change projects in an urban parish to see if there is improvement in these assessments scores. 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 following the implementation of the community change projects in a rural parish to see if there is improvement in these assessments scores.

Design Outcomes

Sequence: 176717191 Sequence: 176717192 Sequence: 176717193 Sequence: 176717194 Sequence: 176717195 Sequence: 176717196
Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary
Measure Attitudes and Beliefs about Living with Epilepsy (ABLE) scores among the community stigma reduction implementation team. Measure Attitudes and Beliefs about Living with Epilepsy (ABLE) scores among the non-community stigma reduction implementation team. Measure Kilifi Stigma Scale scores among adolescents with epilepsy Measure Quality of Life for Epilepsy in Adolescents scores Measure Beck Youth Inventory for depression (BDI-Youth) scores among adolescents with epilepsy Measure Columbia Suicide Severity Rating Scale (C-SSRS) scores for the adolescents living with epilepsy.
Time Frame two years Time Frame two years Time Frame two years Time Frame two years Time Frame two years Time Frame two years
Description 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) Description 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). Description 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. Description 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). Description 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). Description 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.

Browse Conditions

Sequence: 192745168 Sequence: 192745169 Sequence: 192745170 Sequence: 192745171
Mesh Term Epilepsy Mesh Term Brain Diseases Mesh Term Central Nervous System Diseases Mesh Term Nervous System Diseases
Downcase Mesh Term epilepsy Downcase Mesh Term brain diseases Downcase Mesh Term central nervous system diseases Downcase Mesh Term nervous system diseases
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48143450 Sequence: 48143451 Sequence: 48143452
Agency Class OTHER Agency Class NIH Agency Class OTHER
Lead Or Collaborator lead Lead Or Collaborator collaborator Lead Or Collaborator collaborator
Name Makerere University Name Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Name Duke University

Eligibilities

Sequence: 30655058
Sampling Method Probability Sample
Gender All
Minimum Age 10 Years
Maximum Age 18 Years
Healthy Volunteers Accepts Healthy Volunteers
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.
Criteria 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
Adult True
Child True
Older Adult False

Calculated Values

Sequence: 254261168
Registered In Calendar Year 2022
Were Results Reported False
Has Single Facility False
Minimum Age Num 10
Maximum Age Num 18
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 4
Number Of Secondary Outcomes To Measure 2

Designs

Sequence: 30401904
Observational Model Ecologic or Community
Time Perspective Prospective

Responsible Parties

Sequence: 28768414
Responsible Party Type Sponsor