- ICH GCP
- US-Register für klinische Studien
- Klinische 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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Dung Jidong, PhD
- Telefonnummer: +44 115 84 86478
- E-Mail: dung.jidong@ntu.ac.uk
Studieren Sie die Kontaktsicherung
- Name: Tarela Ike, PhD
- Telefonnummer: +44 1642 34 2316
- E-Mail: t.ike@tees.ac.uk
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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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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Aktiver Komparator: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Trauma Screening Questionnaire
Zeitfenster: 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
Zeitfenster: 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
|
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Patient Health Questionnaire
Zeitfenster: 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
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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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Generalised Anxiety Disorder Scale
Zeitfenster: 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
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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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Legal-Education Awareness Scale
Zeitfenster: 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 awareness of human right 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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Attitude Towards Repentant Terrorists and their Reintegration Scale
Zeitfenster: 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
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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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brief Verona Service Satisfaction Scale
Zeitfenster: 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
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Change is being assessed at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Dung Jidong, PhD, Nottingham Trent University, UK
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Voraussichtlich)
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 0000-0001-5034-0335d
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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