- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dung Jidong, PhD
- Phone Number: +44 115 84 86478
- Email: dung.jidong@ntu.ac.uk
Study Contact Backup
- Name: Tarela Ike, PhD
- Phone Number: +44 1642 34 2316
- Email: t.ike@tees.ac.uk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
|
Active Comparator: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Trauma Screening Questionnaire
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dung Jidong, PhD, Nottingham Trent University, UK
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0000-0001-5034-0335d
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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