跳至主要内容
临床试验/NCT06154655
NCT06154655招募中不适用

Hybrid E-zine Health Education Intervention Integrated Within a Mental Health Package for Adolescent Perinatal Depression

University of Ibadan2 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2023年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
63
试验地点
2
主要终点
Edinburgh Postnatal Depression Scale (EPDS)

研究概览

简要总结

The goal of this clinical trial is to develop a hybrid E-zine health education intervention integrated within a mental Health package for adolescent perinatal depression.

The main objective is to:

  • Develop a hybrid Health Educational Intervention offering health promotion and disease prevention services on climate change to perinatal adolescents and their caregivers.
  • Study the feasibility, acceptability, and usability of E-zineMH in a pilot trial among perinatal adolescents and their caregivers in comparison to a control arm that delivers face-to-face health education in routine antenatal clinics.

Participants will be expected to attend routine antenatal appointments for the duration of the study.

In addition to the face-to-face health education delivered to both groups, the intervention group will be exposed to e-magazines on climate change.

详细描述

Rising temperatures in tropical regions threaten the mental and overall wellbeing of perinatal adolescents and their infants, increasing their risks of depression and adverse obstetric complications such as miscarriages, preterm birth, low infant birth weight and still births. Integrated health promotion and prevention programmes within collaborative mental health packages in antenatal clinics that recognise the vital roles of family and other caregivers while also offering conveniently accessible services are crucial to implementing behavioural change interventions to address the negative impact of climate change (CCH) in the perinatal adolescent population.

In Nigeria, perinatal adolescents do not enjoy the privileges of division of labour in their households. However, they continue to engage in formal family or informal services (e.g., street hawking, outdoor errands) for extended periods in temperatures of up to 44 °C (111.2 °F). Also, pre-existing multidimensional health vulnerabilities in this population are compounded by (1) continuous exposure to household pollution from indoor cooking fuelled with biomass and use of poisonous pesticides. (2) Droughts and floods from extreme temperatures in tropical climates have increased food insecurity, reduced access to portable clean water, and worsened risks of infectious diseases like malaria and zika virus. The United Nations recommends health education as a key approach to addressing the detrimental effects of CCH. Despite the effectiveness of health education programmes in the antenatal population in areas of nutrition intake, family planning methods, obstetrics complications, and common infections in the perinatal period, very little recognition has been given to themes of CCH as part of essential services in antenatal clinics in primary care in Nigeria. Barriers to implementing environmental health care as part of integrated packages in primary care in Nigeria are high at the needs (context-relevant), service (capacity of providers), and consumer awareness (uptake of services) levels.

Our proposed study addresses context-relevant needs, health workers capacity, and service uptake gaps, by leveraging Virtual space to deliver a Health Education intervention to address impact of CC in perinatal adolescents. Services on health promotion and prevention will be delivered electronically (eHealth) through E-zine (electronic magazine) photos to perinatal adolescents and their caregivers (e.g., parents, partner or guardian). The E-zine would be integrated within an existing hybrid mental health collaborative model in primary care to promote healthy practices to prevent adverse health outcomes of CCH. E-zine photo system development will be guided by key constructs of the Transtheoretical model. Health prevention and promotion content of the E-zine photos will 1) utilise social support to address unhealthy behaviours 2) use context relevant materials to educate and raise awareness on CCH to affect attitudes and beliefs of perinatal adolescents and their caregivers 3) provide risk mitigation information through a pros and cons analysis to create decisional balance, and 4) address self-efficacy to maintain healthy behaviours.

This application builds on the evidence and lessons learned from studies conducted by the PI (Dr. Kola's-K43TW011046-4) in Nigeria on mhGAP -perinatal depression integrated model within primary care, mHealth and technology strategy testing, and implementation system development research. As part of a K43 emerging global leader award, the investigators designed and developed a self-management mobile phone application as an adjunct treatment and part of a hybrid (face-to-face + mobile phone follow-up care) intervention for perinatal adolescents. The intervention was designed to deliver treatment that promote positive mental and overall wellbeing in perinatal adolescents using an age and culturally appropriate approach.

Health Education Intervention in the perinatal population. Health Education Intervention in the perinatal population-HEI have been effective in positively impacting knowledge and behavioural attitudes of pregnant women to enable them control and change their lifestyles for improved health outcomes. Notwithstanding the success of HEI in addressing areas of nutrition intake, family planning methods, obstetrics complications, and common infections of perinatal women in Nigeria, very little recognition have been given to themes of CCH as part of essential services in antenatal clinics in primary care. Barriers to implementing HEI for environmental health care as part of an integrated packages in primary care in Nigeria are high at the needs (context-relevant), service (capacity of providers), and consumer (uptake of services) levels. Specifically, there are no well documented information presenting health needs assessment of CCH in the perinatal adolescents as a way of defining and systematic identifying the unmet needs to this population. Services on health related impact of CCH are currently not part of the health education services delivered in majority of the antennal clinics in Nigeria and care givers also lack knowledge on the relevance of CCH and it impact on the health of perinatal women.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

The outcome assessment will be carried at four months post baseline by 2 outcome assessors blind to study arm.

入排标准

年龄范围
16 Years 至 21 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Perinatal adolescents aged 16-21 years and below Participants would live in the study area for the 4 months of study participation.
  • Participants provide informed consent.

排除标准

  • Patients needing immediate medical attention Patients that would not be available in the neighborhood for up to 4 months duration in the study

结局指标

主要结局

Edinburgh Postnatal Depression Scale (EPDS)

时间窗: Four months after baseline

The Edinburgh Postnatal Depression Scale (EPDS) is a screening tool for perinatal depression. The cut off for depression is a score equal or greater than 12 point.

次要结局

  • WHO Disability Assessment Schedule (WHODAS 2.0)(Four months after baseline)
  • General Health Questionnaire - 28 (GHQ-28)(Four months after baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lola Kola

Principal Investigator

University of Ibadan

研究点 (2)

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