Health Sciences Research Institute, Warwick Medical School, University of Warwick, Coventry, UK.
BMJ Open. 2013 Aug 1;3(8):e002851. doi: 10.1136/bmjopen-2013-002851.
To evaluate the effectiveness and cost utility of a universally provided early years parenting programme.
Multicentre randomised controlled trial with cost-effectiveness analysis.
Early years centres in four deprived areas of South Wales.
Families with children aged between 2 and 4 years. 286 families were recruited and randomly allocated to the intervention or waiting list control.
The Family Links Nurturing Programme (FLNP), a 10-week course with weekly 2 h facilitated group sessions.
Negative and supportive parenting, child and parental well-being and costs assessed before the intervention, following the course (3 months) and at 9 months using standardised measures.
There were no significant differences in primary or secondary outcomes between trial arms at 3 or 9 months. With '+' indicating improvement, difference in change in negative parenting score at 9 months was +0.90 (95%CI -1.90 to 3.69); in supportive parenting, +0.17 (95%CI -0.61 to 0.94); and 12 of the 17 secondary outcomes showed a non-significant positive effect in the FLNP arm. Based on changes in parental well-being (SF-12), the cost per quality-adjusted life year (QALY) gained was estimated to be £34 913 (range 21 485-46 578) over 5 years and £18 954 (range 11 664-25 287) over 10 years. Probability of cost per QALY gained below £30 000 was 47% at 5 years and 57% at 10 years. Attendance was low: 34% of intervention families attended no sessions (n=48); only 47% completed the course (n=68). Also, 19% of control families attended a parenting programme before 9-month follow-up.
Our trial has not found evidence of clinical or cost utility for the FLNP in a universal setting. However, low levels of exposure and contamination mean that uncertainty remains.
The trial is registered with Current Controlled Trials ISRCTN13919732.
评估普遍提供的早期育儿方案的有效性和成本效用。
多中心随机对照试验，结合成本效益分析。
南威尔士四个贫困地区的早期儿童中心。
年龄在 2 至 4 岁之间的家庭。共招募了 286 个家庭，并随机分配到干预组或等待名单对照组。
家庭链接培育计划（FLNP），一个为期 10 周的课程，每周有 2 小时的小组辅导。
在干预前、课程结束后（3 个月）和 9 个月时使用标准化措施评估消极和支持性育儿、儿童和父母的健康状况以及成本。
在 3 或 9 个月时，试验组之间的主要或次要结果均无显著差异。在 9 个月时，消极育儿评分的变化差异为+0.90（95%CI-1.90 至 3.69）；支持性育儿评分的变化差异为+0.17（95%CI-0.61 至 0.94）；17 个次要结果中有 12 个在 FLNP 组中显示出无统计学意义的积极效果。基于父母健康状况（SF-12）的变化，估计在 5 年内，每获得一个质量调整生命年（QALY）的成本为 34913 英镑（范围为 21485-46578 英镑），在 10 年内为 18954 英镑（范围为 11664-25287 英镑）。在 5 年内，每获得一个质量调整生命年（QALY）的成本低于 30000 英镑的概率为 47%，在 10 年内为 57%。出勤率低：34%的干预家庭未参加任何课程（n=48）；只有 47%的家庭完成了课程（n=68）。此外，在 9 个月的随访前，有 19%的对照组家庭参加了育儿课程。
在普遍环境下，我们的试验没有发现 FLNP 在临床或成本效用方面的证据。然而，低暴露率和低污染率意味着仍然存在不确定性。
该试验在当前对照试验 ISRCTN8466451 注册。
