NCT06601023

Brief Summary

Gender-based violence and, more specifically, domestic violence is a prevalent problem globally and in Nigeria. Its effect significantly impacts women and also the wellbeing of their families. Limited access to support has posed a constraint in effectively addressing the issues suffered by affected victims in Nigeria. In addition, gender-based violence could affect parenting due to factors such as anxiety, trauma, depression, poor social support, limited 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 the child development, wellbeing and the potential subsequent resort to criminal behaviours. In essence, the current study aims to test the feasibility and acceptability of a novel cross disciplinary intervention titled, Problem Management plus Mindfulness-informed Legal Education (PM+MiLE) for addressing gender-based violence and improving parenting in Nigeria in comparison to the waitlist control group for the purposes of improving social cohesion, legal awareness, wellbeing and reducing depression, including trauma and anxiety as a result of experiencing gender-based violence, in Nigeria.

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 Sep 2024

Shorter than P25 for not_applicable

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 14, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

September 24, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

September 19, 2024

Status Verified

August 1, 2024

Enrollment Period

8 months

First QC Date

September 14, 2024

Last Update Submit

September 17, 2024

Conditions

Keywords

DepressionStressAnxietyTraumaGender-based violenceParentingDomestic violenceWomen

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.

    6 weeks at the end of intervention

Secondary Outcomes (9)

  • Gender-based Violence, Stress and Parenting Scale

    Baseline, end of intervention and 3 months post intervention.

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

    Baseline, 6 weeks end of intervention and 3 months post intervention.

  • Generalised Anxiety Disorder (GAD-7)

    Baseline, 6 weeks end of intervention and 3 months post intervention.

  • Oslo Social Support Scale (OSSS-3)

    Baseline, 6 weeks end of intervention and 3 months post intervention.

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

    Baseline, 6 weeks end of intervention and 3 months post intervention.

  • +4 more secondary outcomes

Study Arms (2)

Problem Management plus Mindfulness-informed LegalEducation (PM+MiLE)

EXPERIMENTAL

The PM+MiLE is a six sessions intervention lasting approximately 90 minutes. A session will be delivered weekly for six week.

Behavioral: Psychosocial intervention

Control - Waitlist Group

NO INTERVENTION

The control group will receive no intervention until after the assessment periods at baseline, end of intervention and 3 months follow up before they will be administered the PM+MiLE.

Interventions

The PM+MiLE is a low-intensity intervention. The intervention will cover relevant aspects of brief mindfulness, legal education, awareness of human rights and challenges of complaint, including support. The problem management ambit will include understanding adversity, managing stress, managing problems, getting going and keep doing, strengthening social support and staying well and looking forward, including positive behaviour modification.The intervention will also incorporate child development and building positive parenting interactions with children.

Problem Management plus Mindfulness-informed LegalEducation (PM+MiLE)

Eligibility Criteria

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

You may qualify if:

  • years and above
  • Female with child(ren) or with caring responsibilities for child(ren).
  • Able to provide full consent for their participation.
  • A resident of the study areas (Delta, Jos, Lagos State, etc.)

You may not qualify if:

  • Less than 18 years
  • Unable to consent
  • Currently undergoing severe mental healthtreatment
  • Unable to speak the English language fl uently

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Oladepo O, Yusuf OB, Arulogun OS. Factors influencing gender based violence among men and women in selected states in Nigeria. Afr J Reprod Health. 2011 Dec;15(4):78-86.

    PMID: 22571109BACKGROUND
  • Aborisade, R.A., (2024). Violence In A Patriarchal Nigerian Society. Routledge International Handbook of Investigative Interviewing and Interrogation, p.372.

    BACKGROUND

MeSH Terms

Conditions

DepressionAnxiety DisordersWounds and Injuries

Interventions

Psychosocial Intervention

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Tarela J. Ike, Dr

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 14, 2024

First Posted

September 19, 2024

Study Start

September 24, 2024

Primary Completion

May 30, 2025

Study Completion

June 30, 2025

Last Updated

September 19, 2024

Record last verified: 2024-08

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.