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

NCT05660239 | Not Yet Recruiting DMC

• 2 other identifiers: 1R01HD106277-01R01HD106277
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (4)

• 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)

  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).

  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.

  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).

  two years

Secondary Outcomes (2)

• Beck Youth Inventory for depression (BDI-Youth) scores among adolescents with epilepsy

  two years

• Columbia Suicide Severity Rating Scale (C-SSRS) scores for the adolescents living with epilepsy.

  two years

Study Arms (2)

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.

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.

Other: Community Intervention

Interventions

Community Intervention OTHER

To evaluate the impact of a community intervention in reducing epilepsy stigma in adolescents.

Wakiso district-Rural Parish; Wakiso district-Urban Parish

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Makerere University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Duke University: collaborator

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Study participants and researchers both know which community change intervention they are receiving or implementing respectively.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 21, 2022
• Study Start: March 1, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 5, 2023

Record last verified: 2023-08