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Problem Management Plus Mindfulness-informed Legal Education for Addressing Gender-based Violence and Improving Parenting

No phase Interventional Depression, Anxiety Trauma Anxiety Parenting Intervention

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Psychosocial intervention.
Who it may be relevant to
Registry conditions: Depression, Anxiety, Trauma, Anxiety, Parenting Intervention. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Problem Management Plus Mindfulness-informed LegalEducation (PM+MiLE) for Addressing Gender-based Violence and Improving Parenting in Nigeria: a Randomised Control Trial

Overview

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.

Interventions

  • Behavioral Psychosocial intervention
    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 developmen

Primary outcome measures

  • Service Satisfaction Scale [Time frame: 6 weeks at the end of intervention]
Secondary outcome measures (9)
  • Gender-based Violence, Stress and Parenting Scale [Time frame: Baseline, end of intervention and 3 months post intervention.]
  • Post-traumatic Stress Disorder Checklist (PCL-5) [Time frame: Baseline, 6 weeks end of intervention and 3 months post intervention.]
  • Generalised Anxiety Disorder (GAD-7) [Time frame: Baseline, 6 weeks end of intervention and 3 months post intervention.]
  • Oslo Social Support Scale (OSSS-3) [Time frame: Baseline, 6 weeks end of intervention and 3 months post intervention.]
  • Legal-informed Awareness of Complaint Channel Scale (LACCS) [Time frame: Baseline, 6 weeks end of intervention and 3 months post intervention.]
  • Harsh Parenting Scale [Time frame: Baseline, 6 weeks end of intervention and 3 months post intervention.]
  • Parenting Stress Scale [Time frame: Baseline, 6 weeks end of intervention and 3 months post intervention.]
  • European Quality of Life Scale EQ-5D-5L [Time frame: Baseline, 6 weeks end of intervention and 3 months post intervention.]
  • Patient Health Questionnaire (PHQ-9) [Time frame: Baseline, 6 weeks end of intervention and 3 months post intervention.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

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

Identifiers

NCT: NCT06601023 · 0000-0003-0516-0313e · PM+MiLE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗