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TraumaFAMiLENCT06628518

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

A study testing FAmily oriented Mindfulness informed Legal Education (FAMiLE) in people with Trauma and Depression, run by Teesside University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Trauma, Depression, Anxiety
What is being tested?
FAmily oriented Mindfulness informed Legal Education (FAMiLE)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
No sites listed yet
Study dates
11 Oct 2024to 29 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

No sites are listed yet.

Tarela J Ike contact

016-423-4231

T.ike@tees.ac.uk

Dung E Jidong, Dr contact

Dung.Jidong@manchester.ac.uk

About this study

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

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.

Being tested
FAmily oriented Mindfulness informed Legal Education (FAMiLE)
Keywords
Parenting intervention, Anxiety, incarceration, family, depression, truama
Medical subject headings
Wounds and Injuries, Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FAmily oriented Mindfulness informed Legal Education (FAMiLE)Behavioural

    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.

Study groups in NCT06628518
Study groupRoleWhat they receive
FAmily oriented Mindfulness informed Legal Education (FAMiLE)ExperimentalThe 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.
Receives: Behavioral: FAmily oriented Mindfulness informed Legal Education (FAMiLE)
Control - Waitlist GroupNo interventionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 4 weeks at the end of intervention

Secondary outcomes (9)

  1. Post-traumatic Stress Disorder Checklist (PCL-5)

    The PCL-5 is a 20-item self-report measure that can be used to assess the 20 DSM-5 symptoms of post traumatic stress disorder. A 5-10 point change represents reliable change (i.e., change not due to chance) and a 10-20 point change represents clinically significant change.

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

  2. Generalised Anxiety Disorder (GAD-7)

    The GAD-7 is a seven item scale for screening, measuring and assessing the severity of generalised anxiety disorder. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.

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

  3. Oslo Social Support Scale (OSSS-3)

    The scale is a 3-item self-reported measure designed for assessing and measuring the level of social support. The sum score ranges from 3 to 14, with high values representing strong levels and low values representing poor levels of social support as indicated as follows: a) 3-8 poor social support, b) 9-11 moderate social support, c) 12-14 strong social support.

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

  4. Legal-informed Awareness of Complaint Channel Scale (LACCS)

    The LACCS is a 10-item scale that is designed for assessing and measuring level of awareness of complaint channels and legal rights. The scale has an overall rating of 30, with 0-7 indicating poor knowledge, 8-15 (average knowledge), 16-22 (good knowledge) and 23-30 (excellent knowledge).

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

  5. Harsh Parenting Scale

    The scale is a 4 item scale use to assess harsh parenting. The scale has a rating of 20 with lower scores indicating non harsh parenting and higher scores indicating severe harsh parenting.

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

  6. Parenting Stress Scale

    The PSS is an 18-item questionnaire for assessing parents' feelings about their parenting role, exploring both positive aspects (e.g. personal development, emotional benefits,) and negative aspects of parenthood (e.g. demands on resources, and feelings of stress). Parental stress scores range from 18 to 90, with lower scores indicating lower levels of parental stress.

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

  7. Patient Health Questionnaire (PHQ-9)

    The Patient Health Questionnaire (PHQ-9) is a 9-item questionnaire that will be used for screening, monitoring, measuring and assessing the severity of depression. Low scores (e.g. 0-4) indicate no depression, however, higher scores (20-27) indicates severe depression.

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

  8. European Quality of Life Scale EQ-5D-5L

    The EQ-5D-5L is a 5 item scale designed to aid assessment of the generic quality of life. In the EQ-5D-5L, each dimension has five response levels: no problems (Level 1); slight (Level 2); moderate (Level 3); severe (Level 4); and extreme problems (Level 5). There are 3,125 possible health states defined by combining one level from each dimension, ranging from 11111 (full health) to 55555 (worst health).

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

  9. Incarceration, Stress and Parenting Scale

    The scale is a 4 item scale that will be use for assessing and measuring incarceration impact, stress and parenting. The scale has an overall rating of 20 with score ranging 1-5 indicating severe stress in parenting, 5-10 indicating moderately severe stress in parenting, 11-15 mild stress in parenting and 16- 20 no stress in parenting.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2024
  2. Study start11 Oct 2024 (estimated)
  3. Primary completion29 Aug 2025 (estimated)
  4. Study completion29 Aug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06628518
Sponsor's protocol ID
0000-0003-0516-0313f
Acronym
FAMiLE
Status last verified
Sep 2024
First submitted
19 Sep 2024
Last updated
8 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data supporting this study cannot be made available due to the sensitive nature and ethical reasons on confidentiality.

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.

    PubMed 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.

Questions about this trial

What is this clinical trial studying?

A study testing FAmily oriented Mindfulness informed Legal Education (FAMiLE) in people with Trauma and Depression, run by Teesside University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Tarela J Ike (016-423-4231, T.ike@tees.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Service Satisfaction Scale (time frame: 4 weeks at the end of intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06628518, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.

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