Clinical trial NCT06628518: FAmily Oriented Mindfulness Informed Legal Education (FAMiLE) Programme for Parent or Carers Affected by Incarceration and Improving Parenting in Nigeria
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Trauma
Depression
Anxiety
Parenting Intervention
Keywords: Parenting intervention
Anxiety
incarceration
family
depression
truama
Lead sponsor: Teesside University
Sponsor class: OTHER
Collaborators: name: University of Manchester
name: Jos University Teaching Hospital
First posted: 2024-10-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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\&#39;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.


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

Primary outcomes:
measure: Service Satisfaction Scale
timeFrame: 4 weeks at the end of intervention
Secondary outcomes:
measure: Post-traumatic Stress Disorder Checklist (PCL-5)
timeFrame: Baseline, 4 weeks end of intervention and 3 months post intervention.
measure: Generalised Anxiety Disorder (GAD-7)
timeFrame: Baseline, 4 weeks end of intervention and 3 months post intervention.
measure: Oslo Social Support Scale (OSSS-3)
timeFrame: Baseline, 4 weeks end of intervention and 3 months post intervention.
measure: Legal-informed Awareness of Complaint Channel Scale (LACCS)
timeFrame: Baseline, 4 weeks end of intervention and 3 months post intervention.
measure: Harsh Parenting Scale
timeFrame: Baseline, 4 weeks end of intervention and 3 months post intervention.
measure: Parenting Stress Scale
timeFrame: Baseline, 4 weeks end of intervention and 3 months post intervention.
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline, 4 weeks end of intervention and 3 months post intervention.
measure: European Quality of Life Scale EQ-5D-5L
timeFrame: Baseline, 4 weeks end of intervention and 3 months post intervention.
measure: Incarceration, Stress and Parenting Scale
timeFrame: Baseline, 4 weeks end of intervention and 3 months post intervention.
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: Adetunji, C.M., Gachuri, E.W. and Wanjao, J.N., (2024). Beyond Spouses&#39; Imprisonment: Expectations of Non-incarcerated Female Partners of Inmates at Nigeria&#39;s Agodi-Ibadan Medium Correctional Facility. Journal of Sociology, Psychology and Religious, 4(1), pp.42-53.