Efficacy of Learning Through Play Plus Intervention to Reduce Maternal Depression for Women With Under-nourished Children: A Randomized Controlled Trial From Pakistan
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 2
- 主要终点
- Depression
研究概览
简要总结
The study aims to:
- Develop a culturally appropriate psychosocial intervention
- Test feasibility and acceptability of psychosocial intervention in women suffering from postnatal depression.
Primary Hypothesis:
Depressed mothers who will receive the group intervention will show significant improvements in terms of symptoms of depression.
Design:
Randomised controlled trial.
Setting:
Outpatient department of Civil hospital Karachi.
Participants:
A total of 84 depressed mothers will be randomised equally to an intervention group and a Treatment as usual control group.
Interventions:
The 12 session multimodal psychosocial intervention will be delivered to mothers in the intervention group over a three months period. Each session would take up to 45 minutes. Control group will receive standard postnatal follow-up.
Outcome measures:
Primary outcome measures would be mothers' scores on Edinburgh Postnatal Depression Scale (EPDS)and Hamilton Depression Rating Scale (HDRS).
详细描述
A number of individual and group interventions targeting maternal depression have been developed and tested, mostly in developed countries. Group-based approaches have usually been used to improve outcomes in children through parent-training programmes. A meta-analysis of such programmes shows that these can also be effective in improving psychosocial and mental health of the mothers. However, a number of health system and cultural differences make it difficult for mental health interventions to be extrapolated from the developed to the developing world.
Design:
The interventions will be assessed using a prospective randomised controlled design, using two groups: psychosocial group therapy (Learning Through Play + principles of Cognitive Behaviour Therapy)and treatment as usual.
Defining the intervention:
The intervention will include a supportive component, an educational component, and practical advice on using health services, a parenting component, and a psychosocial component. The objective will be to help mothers feel supported, empowered and confident about their parenting abilities, which in turn may help to reduce their level of depression. Further qualitative testing of the intervention will take place to refine the manualized 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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Depressed mothers over the age of 18 years
- •Having one or more infants 6-18 months old
- •Ability to give informed consent
- •Resident in the study catchment area
排除标准
- •Women or child with diagnosed physical or learning disability and women having post-partum or other psychosis
研究组 & 干预措施
Complex Intervention (LTP-TH)
The 12 sessions of complex intervention (LTP-TH) will be delivered to mothers.
干预措施: Complex Intervention (Behavioral)
Control group
Control group will receive standard postnatal follow-up.
结局指标
主要结局
Depression
时间窗: 6 months
We will measure change from baseline in symptoms of depression through Hamilton Depression Rating Scale (HDRS) at six months by using 17 item HDRS.
Postnatal Depression
时间窗: 6 months
Edinburgh Postnatal Depression Scale (EPDS) will be used to identify mothers with postnatal depression.
次要结局
- Infants' weight(6 months)
- Maternal Attachment(6 months)
- Infants' height(6 months)
- Social Support(6 months)
- health related quality of life(6 months)