Development and Assessment of a Mobile Phone Based Intervention to Reduce Maternal Depression and Improve Child Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 208
- 试验地点
- 4
- 主要终点
- Edinburgh Postnatal Depression Scale (EPDS)
研究概览
简要总结
The prevalence rate of maternal depression in Pakistani women and its effect on the growth and development of young children and child mortality is very high.
The main objective of this study is to increase access to evidence based psychological interventions for mothers who have children of age 0 to 30 months, consistent with her values. The study will be a 2 (conditions) into 3 (Time) single blind randomized controlled trail. Depressed mothers will be randomized either to intervention arm or control arm. Intervention will include text messages based on Learning Through Play Plus (LTP plus CBT).
详细描述
Disturbances in mother-infant relationship in depressed mothers negatively influence the child's development. There are a number of efficient treatments for postnatal depression including antidepressant medication, psychotherapy and psychosocial interventions. Tele-health and mobile health is a novel and emerging field in psychiatric and psychological care and treatment of mental health difficulties, it involves the use of telecommunications to provide health care, support and intervention from a distance.
The proposed study will test the efficacy of an innovative, affordable mobile based intervention program that can help mothers with postnatal depression in low resource countries such as Pakistan.
Participants will be recruited from maternal and child care centres in Karachi, Pakistan and those participants (n = 204) meeting inclusion criteria of the study will be randomized into one of the 2 treatment arms, i.e., intervention or control, after completion of baseline assessment. Intervention will be comprised of LTP Plus and will be delivered through text messages. Momentary Sampling assessment and Momentary Psychological intervention will be part of this study. Participants will be assessed again after completion of intervention (i.e., after 12 weeks) and then 3 months post intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Mothers with mild to moderate depression will be included
- •Mother of children age 0-30months
- •The age range in the study is 18 to 44 years
- •Participants having mobile phones will be included
排除标准
- •Subjects will not be included if they had a diagnosed medical condition or significant physical or learning disability
- •Any form of psychosis, or are currently under psychiatric care.
- •Mothers with severe depression or suicidal ideation will not be included
- •Mothers who will be receiving any psychological intervention will be excluded
- •Mothers of children with any serious medical or psychiatric illness will also be excluded.
结局指标
主要结局
Edinburgh Postnatal Depression Scale (EPDS)
时间窗: change in scores from baseline to 3rd month and 6th month
EPDS will be used to screen depression in mothers with child 0-30 months.
次要结局
- EuroQoL-5 Dimensions (EQ-5D)(change in scores from baseline to 3rd month and 6th month)
- Knowledge of Expectation and Child Development(change in scores from baseline to 3rd month and 6th month)
- Assessment of the growth and development of children (Height)(Change in scores from Baseline and 6 month)
- Patient Health Questionnaire (PHQ-9)(change in scores from baseline to 3rd month and 6th month)
- Generalized Anxiety Disorder - 7 (GAD-7)(change in scores from baseline to 3rd month and 6th month)
- Clinical Interview Schedule Revised (CISR)(Change in scores from baseline to 3rd month and 6th month)
- Assessment of the growth and development of children (Weight)(Change in scores from Baseline and 6 month)