Health TrialsbyHealthPanel

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

ConditionEpilepsy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-18
SponsorMakerere University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Community Intervention

    Other intervention

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

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Wakiso district-Urban ParishOther 1 intervention
Group B: Wakiso district-Rural ParishOther 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
two years
2

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).

Time frame
two years
3

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.

Time frame
two years
4

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).

Time frame
two years

Secondary outcomes

1

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).

Time frame
two years
2

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.

Time frame
two years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Makerere University

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Duke University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: