- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Očekávaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Dung Jidong, PhD
- Telefonní číslo: +44 115 84 86478
- E-mail: dung.jidong@ntu.ac.uk
Studijní záloha kontaktů
- Jméno: Tarela Ike, PhD
- Telefonní číslo: +44 1642 34 2316
- E-mail: t.ike@tees.ac.uk
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: 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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Aktivní komparátor: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Trauma Screening Questionnaire
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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 of attitude towards repentant terrorists 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
|
brief Verona Service Satisfaction Scale
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Dung Jidong, PhD, Nottingham Trent University, UK
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Očekávaný)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 0000-0001-5034-0335d
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