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

October 3, 2024 updated by: Tarela Ike, Teesside University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: FAmily oriented Mindfulness informed Legal Education (FAMiLE)
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)
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.
No Intervention: Control - Waitlist Group
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Service Satisfaction Scale
Time Frame: 4 weeks at the end of intervention
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Post-traumatic Stress Disorder Checklist (PCL-5)
Time Frame: Baseline, 4 weeks end of intervention and 3 months post intervention.
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.
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.
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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).
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.
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.
Baseline, 4 weeks end of intervention and 3 months post intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Teesside University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Manchester
Jos University Teaching Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 11, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 29, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 29, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 8, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0000-0003-0516-0313f

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings