Clinical trial NCT06601023: Problem Management Plus Mindfulness-informed Legal Education for Addressing Gender-based Violence and Improving Parenting
Official title: Problem Management Plus Mindfulness-informed LegalEducation (PM+MiLE) for Addressing Gender-based Violence and Improving Parenting in Nigeria: a Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression, Anxiety
Trauma
Anxiety
Parenting Intervention
Woman Abuse
Child Behaviour
Stress
Keywords: Depression
Stress
Anxiety
Trauma
Gender-based violence
Parenting
Domestic violence
Women
Lead sponsor: Teesside University
Sponsor class: OTHER
Collaborators: name: Jos University Teaching Hospital
name: University of Manchester
First posted: 2024-09-19
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 18 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.)

Exclusion Criteria:

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

Primary outcomes:
measure: Service Satisfaction Scale
timeFrame: 6 weeks at the end of intervention
Secondary outcomes:
measure: Gender-based Violence, Stress and Parenting Scale
timeFrame: Baseline, end of intervention and 3 months post intervention.
measure: Post-traumatic Stress Disorder Checklist (PCL-5)
timeFrame: Baseline, 6 weeks end of intervention and 3 months post intervention.
measure: Generalised Anxiety Disorder (GAD-7)
timeFrame: Baseline, 6 weeks end of intervention and 3 months post intervention.
measure: Oslo Social Support Scale (OSSS-3)
timeFrame: Baseline, 6 weeks end of intervention and 3 months post intervention.
measure: Legal-informed Awareness of Complaint Channel Scale (LACCS)
timeFrame: Baseline, 6 weeks end of intervention and 3 months post intervention.
measure: Harsh Parenting Scale
timeFrame: Baseline, 6 weeks end of intervention and 3 months post intervention.
measure: Parenting Stress Scale
timeFrame: Baseline, 6 weeks end of intervention and 3 months post intervention.
measure: European Quality of Life Scale EQ-5D-5L
timeFrame: Baseline, 6 weeks end of intervention and 3 months post intervention.
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline, 6 weeks end of intervention and 3 months post intervention.
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: Aborisade, R.A., (2024). Violence In A Patriarchal Nigerian Society. Routledge International Handbook of Investigative Interviewing and Interrogation, p.372.