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NCT Number: NCT06601023

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

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.

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Key information

Conditions

Depression, Anxiety Anxiety Anxiety Disorders Behavior Behavioral Symptoms Child Behaviour Depression Mental Disorders Parenting Intervention Stress Trauma Woman Abuse Wounds and Injuries

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychosocial intervention

Behavioral

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.

Primary outcomes

  1. Service Satisfaction Scale

    Time frame: 6 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.

Secondary outcomes

  1. Gender-based Violence, Stress and Parenting Scale

    Time frame: Baseline, end of intervention and 3 months post intervention.

    The scale is a 4 item scale that will be use for assessing and measuring gender-based violence, 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.

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

    Time frame: Baseline, 6 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.

  3. Generalised Anxiety Disorder (GAD-7)

    Time frame: Baseline, 6 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.

  4. Oslo Social Support Scale (OSSS-3)

    Time frame: Baseline, 6 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.

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

    Time frame: Baseline, 6 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).

  6. Harsh Parenting Scale

    Time frame: Baseline, 6 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.

  7. Parenting Stress Scale

    Time frame: Baseline, 6 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.

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

    Time frame: Baseline, 6 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).

  9. Patient Health Questionnaire (PHQ-9)

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

    This 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dung E Jidong, Dr

CONTACT

[email protected]

Tarela J. Ike, Dr

CONTACT

[email protected]

016-423-4231

Sponsors and collaborators

Lead sponsor

Teesside University

Other

Collaborators

  • Jos University Teaching Hospital
  • University of Manchester

Registry information

Official study title

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

Acronym: PM+MiLE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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