Division of Psychiatry, Imperial College London, London, UK.
Centre for Research on Play in Education, Development, and Learning, Faculty of Education, University of Cambridge, Cambridge, UK.
Health Technol Assess. 2021 May;25(29):1-84. doi: 10.3310/hta25290.
Behaviour problems emerge early in childhood and place children at risk for later psychopathology.
To evaluate the clinical effectiveness and cost-effectiveness of a parenting intervention to prevent enduring behaviour problems in young children.
A pragmatic, assessor-blinded, multisite, two-arm, parallel-group randomised controlled trial.
Health visiting services in six NHS trusts in England.
A total of 300 at-risk children aged 12-36 months and their parents/caregivers.
Families were allocated in a 1 : 1 ratio to six sessions of Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline (VIPP-SD) plus usual care or usual care alone.
The primary outcome was the Preschool Parental Account of Children's Symptoms, which is a structured interview of behaviour symptoms. Secondary outcomes included caregiver-reported total problems on the Child Behaviour Checklist and the Strengths and Difficulties Questionnaire. The intervention effect was estimated using linear regression. Health and social care service use was recorded using the Child and Adolescent Service Use Schedule and cost-effectiveness was explored using the Preschool Parental Account of Children's Symptoms.
In total, 300 families were randomised: 151 to VIPP-SD plus usual care and 149 to usual care alone. Follow-up data were available for 286 (VIPP-SD, = 140; usual care, = 146) participants and 282 (VIPP-SD, = 140; usual care, = 142) participants at 5 and 24 months, respectively. At the post-treatment (primary outcome) follow-up, a group difference of 2.03 on Preschool Parental Account of Children's Symptoms (95% confidence interval 0.06 to 4.01; = 0.04) indicated a positive treatment effect on behaviour problems (Cohen's = 0.20, 95% confidence interval 0.01 to 0.40). The effect was strongest for children's conduct [1.61, 95% confidence interval 0.44 to 2.78; = 0.007 ( = 0.30, 95% confidence interval 0.08 to 0.51)] versus attention deficit hyperactivity disorder symptoms [0.29, 95% confidence interval -1.06 to 1.65; = 0.67 ( = 0.05, 95% confidence interval -0.17 to 0.27)]. The Child Behaviour Checklist [3.24, 95% confidence interval -0.06 to 6.54; = 0.05 ( = 0.15, 95% confidence interval 0.00 to 0.31)] and the Strengths and Difficulties Questionnaire [0.93, 95% confidence interval -0.03 to 1.9; = 0.06 ( = 0.18, 95% confidence interval -0.01 to 0.36)] demonstrated similar positive treatment effects to those found for the Preschool Parental Account of Children's Symptoms. At 24 months, the group difference on the Preschool Parental Account of Children's Symptoms was 1.73 [95% confidence interval -0.24 to 3.71; = 0.08 ( = 0.17, 95% confidence interval -0.02 to 0.37)]; the effect remained strongest for conduct [1.07, 95% confidence interval -0.06 to 2.20; = 0.06 ( = 0.20, 95% confidence interval -0.01 to 0.42)] versus attention deficit hyperactivity disorder symptoms [0.62, 95% confidence interval -0.60 to 1.84; = 0.32 ( = 0.10, 95% confidence interval -0.10 to 0.30)], with little evidence of an effect on the Child Behaviour Checklist and the Strengths and Difficulties Questionnaire. The primary economic analysis showed better outcomes in the VIPP-SD group at 24 months, but also higher costs than the usual-care group (adjusted mean difference £1450, 95% confidence interval £619 to £2281). No treatment- or trial-related adverse events were reported. The probability of VIPP-SD being cost-effective compared with usual care at the 24-month follow-up increased as willingness to pay for improvements on the Preschool Parental Account of Children's Symptoms increased, with VIPP-SD having the higher probability of being cost-effective at willingness-to-pay values above £800 per 1-point improvement on the Preschool Parental Account of Children's Symptoms.
The proportion of participants with graduate-level qualifications was higher than among the general public.
VIPP-SD is effective in reducing behaviour problems in young children when delivered by health visiting teams. Most of the effect of VIPP-SD appears to be retained over 24 months. However, we can be less certain about its value for money.
Current Controlled Trials ISRCTN58327365.
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 25, No. 29. See the NIHR Journals Library website for further project information.
行为问题在儿童早期出现，并使儿童面临日后出现精神病理学的风险。
评估一种育儿干预措施预防幼儿持续行为问题的临床有效性和成本效益，该干预措施是通过视频反馈促进积极育儿和敏感纪律（VIPP-SD）来实现的。
一项实用的、评估者盲法的、多地点、两臂、平行组随机对照试验。
英格兰六个 NHS 信托基金的健康访视服务。
共有 300 名年龄在 12-36 个月之间、有风险的儿童及其父母/照顾者。
家庭以 1:1 的比例分配到六节视频反馈干预促进积极育儿和敏感纪律（VIPP-SD）加常规护理或常规护理。
主要结局是学前父母对儿童症状的评估，这是对行为症状的结构化访谈。次要结局包括照顾者报告的儿童行为检查表和困难问卷的总问题。干预效果使用线性回归进行估计。使用儿童和青少年服务使用时间表记录健康和社会保健服务的使用情况，并使用学前父母对儿童症状的评估探索成本效益。
共有 300 个家庭被随机分配：151 个接受 VIPP-SD 加常规护理，149 个接受常规护理。286 名（VIPP-SD，=140；常规护理，=146）参与者和 282 名（VIPP-SD，=140；常规护理，=142）参与者分别在治疗后（主要结局）随访时和 5 个月和 24 个月时获得了随访数据。在治疗后随访时，学前父母对儿童症状的评估（0.06 至 4.01；=0.04）的 2.03 分差异表明行为问题有积极的治疗效果（Cohen's =0.20，95%置信区间 0.01 至 0.40）。该效果在儿童行为中的最强[1.61，95%置信区间 0.44 至 2.78；=0.007（=0.30，95%置信区间 0.08 至 0.51）]，而在注意力缺陷多动障碍症状中较弱[0.29，95%置信区间-1.06 至 1.65；=0.67（=0.05，95%置信区间 0.17 至 0.27）]。儿童行为检查表[3.24，95%置信区间-0.06 至 6.54；=0.05（=0.15，95%置信区间 0.00 至 0.31）]和困难问卷[0.93，95%置信区间-0.03 至 1.9；=0.06（=0.18，95%置信区间-0.01 至 0.36）]也表现出类似的积极治疗效果。在 24 个月时，学前父母对儿童症状的评估的组间差异为 1.73[95%置信区间-0.24 至 3.71；=0.08（=0.17，95%置信区间-0.02 至 0.37）]；该效果仍然在行为中最强[1.07，95%置信区间-0.06 至 2.20；=0.06（=0.20，95%置信区间-0.01 至 0.42）]，而在注意力缺陷多动障碍症状中较弱[0.62，95%置信区间-0.60 至 1.84；=0.32（=0.10，95%置信区间-0.10 至 0.30）]，对儿童行为检查表和困难问卷的影响很小。主要的经济分析表明，在 24 个月时，VIPP-SD 组的结果更好，但成本也高于常规护理组（调整后的平均差异为 1450 英镑，95%置信区间为 619 至 2281 英镑）。没有报告与治疗或试验相关的不良事件。随着对学前父母对儿童症状的评估的改善的意愿支付的增加，VIPP-SD 在 24 个月随访时的成本效益的可能性增加，随着 VIPP-SD 在超过每改善 1 分学前父母对儿童症状的评估的意愿支付值为 800 英镑以上时，更有可能具有成本效益。
参与者中具有研究生学历的比例高于普通公众。
当由健康访视团队提供时，VIPP-SD 可有效减少幼儿的行为问题。VIPP-SD 的大部分效果似乎在 24 个月时仍能保留。然而，我们对其性价比的信心要小一些。
当前对照试验 ISRCTN58327365。
本项目由英国国家卫生研究所（NIHR）卫生技术评估计划资助，将在 ; 第 25 卷，第 29 期上全文发表。有关该项目的更多信息，请访问 NIHR 期刊库网站。
