NCT06628518

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\'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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 8, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

October 11, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2025

Completed
Last Updated

October 8, 2024

Status Verified

September 1, 2024

Enrollment Period

11 months

First QC Date

September 19, 2024

Last Update Submit

October 3, 2024

Conditions

Keywords

Parenting interventionAnxietyincarcerationfamilydepressiontruama

Outcome Measures

Primary Outcomes (1)

  • Service Satisfaction Scale

    A five item scale that can be used to assess and measure satisfaction, acceptability and quality of the intervention. Higher score denote positive outcomes and acceptability. Lower score denotes poor satisfaction and acceptability.

    4 weeks at the end of intervention

Secondary Outcomes (9)

  • Post-traumatic Stress Disorder Checklist (PCL-5)

    Baseline, 4 weeks end of intervention and 3 months post intervention.

  • Generalised Anxiety Disorder (GAD-7)

    Baseline, 4 weeks end of intervention and 3 months post intervention.

  • Oslo Social Support Scale (OSSS-3)

    Baseline, 4 weeks end of intervention and 3 months post intervention.

  • Legal-informed Awareness of Complaint Channel Scale (LACCS)

    Baseline, 4 weeks end of intervention and 3 months post intervention.

  • Harsh Parenting Scale

    Baseline, 4 weeks end of intervention and 3 months post intervention.

  • +4 more secondary outcomes

Study Arms (2)

FAmily oriented Mindfulness informed Legal Education (FAMiLE)

EXPERIMENTAL

The FAmily oriented Mindfulness informed Legal Education (FAMiLE) is a four sessions intervention lasting approximately 90 minutes each. A session will be delivered weekly for 4 weeks.

Behavioral: FAmily oriented Mindfulness informed Legal Education (FAMiLE)

Control - Waitlist Group

NO INTERVENTION

The control group will not receive an intervention until after the assessment periods at baseline, end of intervention and 3 months follow up before they will be administered the FAMiLE intervention.

Interventions

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 gains. The intervention will also incorporate positive parenting and interactions with children.

FAmily oriented Mindfulness informed Legal Education (FAMiLE)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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: 36313982BACKGROUND
  • 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.

    BACKGROUND

MeSH Terms

Conditions

Wounds and InjuriesDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Central Study Contacts

Tarela J Ike

CONTACT

Dung E Jidong, Dr

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer and Principal Investigator

Study Record Dates

First Submitted

September 19, 2024

First Posted

October 8, 2024

Study Start

October 11, 2024

Primary Completion

August 29, 2025

Study Completion

August 29, 2025

Last Updated

October 8, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Data supporting this study cannot be made available due to the sensitive nature and ethical reasons on confidentiality.