Health Sciences Research Institute, Warwick Medical School, University of Warwick, Coventry, CV4 7AL, England.
BMC Public Health. 2010 Jun 23;10:364. doi: 10.1186/1471-2458-10-364.
Sub-optimal parenting is a common risk factor for a wide range of negative health, social and educational outcomes. Most parenting programmes have been developed in the USA in the context of delinquency prevention for targeted or indicated groups and the main theoretical underpinning for these programmes is behaviour management. The Family Links Nurturing Programme (FLNP) focuses on family relationships as well as behaviour management and is offered on a universal basis. As a result it may be better placed to improve health and educational outcomes. Developed in the UK voluntary sector, FLNP is popular with practitioners, has impressed policy makers throughout the UK, has been found to be effective in before/after and qualitative studies, but lacks a randomised controlled trial (RCT) evidence base.
METHODS/DESIGN: A multi-centre, investigator blind, randomised controlled trial of the FLNP with a target sample of 288 south Wales families who have a child aged 2-4 yrs living in or near to Flying Start/Sure Start areas. Changes in parenting, parent child relations and parent and child wellbeing are assessed with validated measures immediately and at 6 months post intervention. Economic components include cost consequences and cost utility analyses based on parental ranking of states of quality of life. Attendance and completion rates and fidelity to the FLNP course delivery are assessed. A nested qualitative study will assess reasons for participation and non-participation and the perceived value of the programme to families. By the end of May 2010, 287 families have been recruited into the trial across four areas of south Wales. Recruitment has not met the planned timescales with barriers including professional anxiety about families entering the control arm of the trial, family concern about video and audio recording, programme facilitator concern about the recording of FLNP sessions for fidelity purposes and delays due to the new UK research governance procedures.
Whilst there are strong theoretical arguments to support universal provision of parenting programmes, few universal programmes have been subjected to randomised controlled trials. In this paper we describe a RCT protocol with quantitative and qualitative outcome measures and an economic evaluation designed to provide clear evidence with regard to effectiveness and costs. We describe challenges implementing the protocol and how we are addressing these.
Current Controlled Trials ISRCTN13919732.
不适当的育儿方式是广泛的负面健康、社会和教育结果的常见危险因素。大多数育儿计划都是在美国制定的，针对的是特定群体或特定群体的预防犯罪，这些计划的主要理论基础是行为管理。家庭联系培育计划（FLNP）侧重于家庭关系以及行为管理，并以普及的方式提供。因此，它可能更有能力改善健康和教育结果。FLNP 是在英国志愿部门开发的，深受从业者欢迎，给英国各地的政策制定者留下了深刻的印象，在前后和定性研究中被发现是有效的，但缺乏随机对照试验（RCT）的证据基础。
方法/设计：一项多中心、研究者盲法、随机对照试验，以 288 个南威尔士家庭为研究对象，这些家庭的孩子年龄在 2-4 岁，居住在飞行起点/确定起点地区或附近。使用经过验证的测量方法，立即和干预后 6 个月评估育儿、亲子关系以及父母和孩子的健康状况的变化。经济组成部分包括基于父母对生活质量状态的排名的成本后果和成本效用分析。评估出勤率和完成率以及对 FLNP 课程交付的保真度。一项嵌套的定性研究将评估参与和不参与的原因以及家庭对该计划的感知价值。截至 2010 年 5 月底，在南威尔士的四个地区共招募了 287 个家庭参加试验。招募没有达到计划的时间表，存在的障碍包括专业人员对家庭进入试验对照组的焦虑、家庭对视频和音频记录的担忧、计划协调员对 FLNP 会议录音以确保真实性的担忧以及由于新的英国研究治理程序而导致的延误。
虽然有强有力的理论论据支持普及育儿计划，但很少有普及计划接受过随机对照试验。在本文中，我们描述了一个 RCT 方案，该方案包括定量和定性的结果测量以及经济评估，旨在提供有关有效性和成本的明确证据。我们描述了实施方案的挑战以及我们如何解决这些问题。
当前对照试验 ISRCTN13919732。
