Improving Mental Health in First Time Parents - A Randomized Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 78
- 主要终点
- Number of symptoms on the BSI 18 and the PFB-K
研究概览
简要总结
In the present pilot study the feasibility and efficacy of Baby Triple P- an antenatal parent training- are investigated. Healthy becoming first time parents were randomly allocated to either the Baby Triple P parent-training group or a care as usual control group. It is expected that 78 couples of becoming first time parents are recruited. It is hypothesized that parents and their infants in the parent training group will show significantly less psychopathology / regulation problems and better partnership quality than participants in the control condition.
详细描述
In this pilot study, the efficacy and feasibility of the Baby Triple P parenting training is investigated in a pilot study using a randomized controlled trial. According to the efficacy of the parenting training, it is expected that parents in the training condition show higher scores on mental health scales (BSI-18) and quality of Partnership (PFB). Furthermore, it is expected that infants whose parents has taken part in the parenting training have lower severity ratings of regulatory disorders assessed with the Baby-DIPS diagnostic interview than infants of parents in the care as usual control condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Becoming first time parent
- •Participants have a basic level of German literacy which allows them to understand the Baby Triple P materials
- •Unborn Baby is developing well and does not have a pre-diagnosed medical condition
排除标准
- •Baby has a disability or pre-diagnosed medical condition.
- •The parents are intellectually disabled
结局指标
主要结局
Number of symptoms on the BSI 18 and the PFB-K
时间窗: Before birth (T1), two months after birth (T2)
The BSI 18 assessment gathers patient-reported data to help measure psychological distress and psychiatric disorders. The relationship questionnaire (PFB-K) assess partnership satisfaction.
Severity rating (0-8) of regulatory problems in infants
时间窗: six months after birth (T3)
Regulatory difficulties in crying, sleeping and feeding behavior in infants are assessed with a diagnostic interview (Baby-DIPS). The severity rating ranges from 0-8 (\> 4 indicates a clinical referred disorder).
次要结局
- Quality of parenting(Two months after birth (T2), six month after birth (T3))
- Number of symptoms on the EPDS, DASS-21 and the OSS-3(Two months after birth (T2))
研究者
Lukka Popp
M.Sc.
Ruhr University of Bochum