- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT05397483
Legal-Education Plus Trauma-informed Therapy to Improve Community Acceptance and Reintegration of Repentant Terrorists in Nigeria (LETiT)
Legal-Education Plus Trauma-informed Therapy to Improve Community Acceptance and Reintegration of Repentant Terrorists in Nigeria: A Pilot Randomised Controlled Trial
Обзор исследования
Статус
Условия
Тип исследования
Регистрация (Ожидаемый)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Dung Jidong, PhD
- Номер телефона: +44 115 84 86478
- Электронная почта: dung.jidong@ntu.ac.uk
Учебное резервное копирование контактов
- Имя: Tarela Ike, PhD
- Номер телефона: +44 1642 34 2316
- Электронная почта: t.ike@tees.ac.uk
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- ages 18 - 85 years
- able to give consent
- able to understand and speak English
- score a minimum of 5 on Trauma Screening Questionnaire
- residents of designated communities of intervention (Adamawa, Maiduguri, and Plateau states)
- available for the study and follow up at 3- and 6-months post-intervention
Exclusion Criteria:
- less than 18 or above 85 years
- unable to give consent
- clinically diagnosed with severe PTSD/suicidal ideations or undergoing treatment
- temporary or non-residents who are unlikely to be available for follow up
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: LETiT
The LETiT intervention will cover (a) Legal education with numerous aspects relating to human rights, access to legal support and tackling traumatic experiences. (b) The Trauma-informed Therapy component will involve addressing trauma, dispelling negative thoughts and building more positive thinking. It is worth adding that the LETiT intervention has undergone standardisation of procedure by adopting a coherent manual (e.g., the Legal Education plus Trauma-informed Therapy manual) specifically designed for the proposed intervention. For example, the legal education contents are collated from extant laws, including the 1999 Constitution of the Federal Republic of Nigeria. |
Group-1: Experimental (n=75 participants) will receive the LETiT which consists of a total of 12-group integrated sessions lasting approximately 60-90 minutes per session every week with 20-25 persons per sub-group.
|
|
Активный компаратор: Intervention As Usual (IAU)
The Intervention As Usual (IAU) component of the proposed project is designed through a systematic collation of numerous government and non-governmental organisations' support information (e.g., news information and basic re-orientation of community members affected by terrorism). Thus, the IAU group will receive the government intervention involving media messages from the National Orientation Agency devoid of legal education or trauma-informed therapy. The training materials are organised to address key aspects of care such as (a) acknowledgement of the severity of lived experiences (b) reflection of current help received from the government and humanitarian services (c) essential aspects of self-care and caring for the vulnerable family and community members (d) inspiration for the future etc. |
Group-2: Controlled (n=75 participants) will receive the IAU which consists of a total of 12-group integrated sessions lasting approximately 60-90 minutes per session every week with 20-25 persons per sub-group.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Trauma Screening Questionnaire
Временное ограничение: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
|
Change in traumatic experience is being assessed
|
Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
|
|
Adaptive Stress Index
Временное ограничение: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
|
Change in stress is being assessed
|
Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
|
|
Patient Health Questionnaire
Временное ограничение: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
|
Change in depression is being assessed
|
Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
|
|
Generalised Anxiety Disorder Scale
Временное ограничение: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
|
Change in anxiety is being assessed
|
Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
|
|
Legal-Education Awareness Scale
Временное ограничение: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
|
Change in awareness of human right is being assessed
|
Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
|
|
Attitude Towards Repentant Terrorists and their Reintegration Scale
Временное ограничение: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
|
Change in of attitude towards repentant terrorists is being assessed
|
Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
|
|
brief Verona Service Satisfaction Scale
Временное ограничение: Change is being assessed at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
|
Change in service satisfaction is being assessed
|
Change is being assessed at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Dung Jidong, PhD, Nottingham Trent University, UK
Даты записи исследования
Изучение основных дат
Начало исследования (Ожидаемый)
Первичное завершение (Ожидаемый)
Завершение исследования (Ожидаемый)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 0000-0001-5034-0335d
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
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Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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