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Набор скоро начнётся NCT06601023

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

Без фазы С лечением Depression, Anxiety Trauma Anxiety Parenting Intervention

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Psychosocial intervention.
Кому может быть актуально
Состояния в реестре: Depression, Anxiety, Trauma, Anxiety, Parenting Intervention. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

  • Поведенческое 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

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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.)

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • 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.

Идентификаторы

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

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗