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Not yet recruiting NCT06628518

FAmily Oriented Mindfulness Informed Legal Education (FAMiLE) Programme for Parent or Carers Affected by Incarceration and Improving Parenting in Nigeria

No phase Interventional Trauma Depression Anxiety Parenting Intervention

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: FAmily oriented Mindfulness informed Legal Education (FAMiLE).
Who it may be relevant to
Registry conditions: Trauma, Depression, Anxiety, Parenting Intervention. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

FAmily Oriented Mindfulness Informed Legal Education (FAMiLE) Programme for Parent or Carers Affected by Incarceration and Improving Parenting in Nigeria: a Randomised Control Trial

Overview

Incarceration is a prevalent problem globally and in Nigeria. Its effect significantly impacts left behind parent or primary care givers and also the wellbeing of the families and children. Limited access to support has posed a constraint in effectively addressing the issues suffered by affected families in Nigeria. In addition, having a family member incarcerated could affect parenting due to factors such as anxiety, trauma, depression, poor social support, awareness of legal channels for complaint and harsh parenting to children. The implication is that it could not only have a negative impact on the affected victim but also on their parenting styles or caring responsibilities, which could be detrimental to children\'s development and wellbeing and resort to criminal behaviours. In essence this study seeks to examine the feasibility and acceptability of a brief FAmily oriented Mindfulness informed Legal Education (FAMiLE) intervention in comparison to the waitlist control group (who will be administered the intervention at a later date) in improving parenting, legal awareness, social cohesion, wellbeing and reducing trauma and anxiety as a result of the effect of having a family member incarcerated.

Interventions

  • Behavioral FAmily oriented Mindfulness informed Legal Education (FAMiLE)
    The FAmily oriented Mindfulness informed Legal Education (FAMiLE) is a low-intensity intervention involving four sessions. The session will cover relevant aspects of brief mindfulness, legal education, awareness of human rights and challenges of complaint, including support. The Family oriented component will include stress management, including coping techniques and problem-solving, positive communication, behaviour modification and parenting, and a session on consolidation including sustaining

Primary outcome measures

  • Service Satisfaction Scale [Time frame: 4 weeks at the end of intervention]
Secondary outcome measures (9)
  • Post-traumatic Stress Disorder Checklist (PCL-5) [Time frame: Baseline, 4 weeks end of intervention and 3 months post intervention.]
  • Generalised Anxiety Disorder (GAD-7) [Time frame: Baseline, 4 weeks end of intervention and 3 months post intervention.]
  • Oslo Social Support Scale (OSSS-3) [Time frame: Baseline, 4 weeks end of intervention and 3 months post intervention.]
  • Legal-informed Awareness of Complaint Channel Scale (LACCS) [Time frame: Baseline, 4 weeks end of intervention and 3 months post intervention.]
  • Harsh Parenting Scale [Time frame: Baseline, 4 weeks end of intervention and 3 months post intervention.]
  • Parenting Stress Scale [Time frame: Baseline, 4 weeks end of intervention and 3 months post intervention.]
  • Patient Health Questionnaire (PHQ-9) [Time frame: Baseline, 4 weeks end of intervention and 3 months post intervention.]
  • European Quality of Life Scale EQ-5D-5L [Time frame: Baseline, 4 weeks end of intervention and 3 months post intervention.]
  • Incarceration, Stress and Parenting Scale [Time frame: Baseline, 4 weeks end of intervention and 3 months post intervention.]

Eligibility criteria

Inclusion criteria

  • 18 years and above
  • Parent or carer with child(ren) or with caring responsibilities for children affected by incarceration.
  • Able to provide full consent for their participation.
  • A resident of the study areas (Delta, Jos or Lagos State)

Exclusion criteria

  • Less than 18 years
  • Unable to consent
  • Currently undergoing severe mental health treatment
  • Unable to speak the English language fluently

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Ogunbosi BO, Adepoju AA, Orimadegun AE, Odaibo GN, Olaleye OD, Akinyinka OO. Challenges of caregivers and needs of children with parents in a Nigerian prison. Niger J Paediatr. 2022 Jul-Sep;49(3):240-244. PMID 36313982
  • Adetunji, C.M., Gachuri, E.W. and Wanjao, J.N., (2024). Beyond Spouses' Imprisonment: Expectations of Non-incarcerated Female Partners of Inmates at Nigeria's Agodi-Ibadan Medium Correctional Facility. Journal of Sociology, Psychology and Religious, 4(1), pp.42-53.

Identifiers

NCT: NCT06628518 · 0000-0003-0516-0313f

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗