- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Dung Jidong, PhD
- Número de teléfono: +44 115 84 86478
- Correo electrónico: dung.jidong@ntu.ac.uk
Copia de seguridad de contactos de estudio
- Nombre: Tarela Ike, PhD
- Número de teléfono: +44 1642 34 2316
- Correo electrónico: t.ike@tees.ac.uk
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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.
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Comparador activo: 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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Trauma Screening Questionnaire
Periodo de tiempo: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
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Change in traumatic experience is being assessed
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Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
|
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Adaptive Stress Index
Periodo de tiempo: 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
Periodo de tiempo: 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
|
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Generalised Anxiety Disorder Scale
Periodo de tiempo: 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
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Legal-Education Awareness Scale
Periodo de tiempo: 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
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Attitude Towards Repentant Terrorists and their Reintegration Scale
Periodo de tiempo: 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
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|
brief Verona Service Satisfaction Scale
Periodo de tiempo: 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
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Dung Jidong, PhD, Nottingham Trent University, UK
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 0000-0001-5034-0335d
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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