BACKGROUND Well Parent Japan (WPJ) is a new hybrid group parent training programme combining sessions to improve mothers' psychological well-being with a culturally adapted version of the New Forest Parenting Programme (NFPP). This study investigates the effectiveness and cost-effectiveness of WPJ against treatment as usual (TAU) within Japanese child mental health services. METHODS TRANSFORM was a pragmatic multi-site randomised controlled trial (RCT) with two parallel arms. Altogether 124 mothers of 6-12-year-old children with DSM-5 ADHD were randomised to WPJ (n = 65) or TAU (n = 59). Participants were assessed at baseline, post-treatment and three-month follow-up. The primary outcome was parent-domain stress following intervention. Secondary outcomes included maternal reports of child-domain stress, parenting practices, parenting efficacy, mood, family strain, child behaviour and impairment. Objective measures of the parent-child relationship were collected at baseline and post-treatment. Data analysis was intention to treat (ITT) with treatment effects quantified through analysis of covariance (ANCOVA) via multilevel modelling. An incremental cost-effectiveness ratio (ICER) assessed WPJ's cost-effectiveness. RESULTS WPJ was superior to TAU in reducing parent-domain stress post-treatment (adjusted mean difference = 5.05, 95% CI 0.33 to 9.81, p = .036) and at follow-up (adjusted mean difference 4.82, 95% CI 0.09 to 9.55, p = .046). Significant WPJ intervention effects were also observed for parenting practices, parenting efficacy and family strain. WPJ and TAU were not significantly different post-intervention or at follow-up for the other secondary outcomes. The incremental cost of WPJ was 34,202 JPY (315.81 USD). The probability that WPJ is cost-effective is 74% at 10,000 JPY (USD 108.30) per one-point improvement in parenting stress, 92% at 20,000 JPY (216.60 USD). The programme was delivered with high fidelity and excellent retention. CONCLUSIONS WPJ can be delivered in routine clinical care at modest cost with positive effects on self-reported well-being of the mothers, parenting practices and family coping. WPJ is a promising addition to psychosocial interventions for ADHD in Japan.

中文翻译：

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一项关于 Well Parent Japan 在日本常规护理中的有效性和成本效益的实用随机对照试验：母亲的培训和养育支持 （TRANSFORM） 研究。


背景 Well Parent Japan （WPJ） 是一项新的混合团体家长培训计划，将改善母亲心理健康的课程与新森林育儿计划 （NFPP） 的文化适应版本相结合。本研究调查了 WPJ 在日本儿童心理健康服务中对常规治疗 （TAU） 的有效性和成本效益。方法 TRANSFORM 是一项实用的多中心随机对照试验 （RCT），具有两个平行组。共有 124 名 6-12 岁 DSM-5 ADHD 儿童的母亲被随机分配到 WPJ 组 （n = 65） 或 TAU 组 （n = 59）。参与者在基线、治疗后和三个月的随访中进行评估。主要结局是干预后的父母领域压力。次要结局包括产妇对儿童领域压力、养育实践、养育效率、情绪、家庭压力、儿童行为和损害的报告。在基线和治疗后收集亲子关系的客观测量。数据分析是意向治疗 （ITT），通过多级建模的协方差分析 （ANCOVA） 量化治疗效果。增量成本效益比 （ICER） 评估了 WPJ 的成本效益。结果 WPJ 在减少治疗后 （调整后的平均差 = 5.05,95% CI 0.33 至 9.81，p = .036） 和随访 （调整后的平均差 4.82,95% CI 0.09 至 9.55，p = .046） 方面优于 TAU。还观察到对育儿实践、育儿效能和家庭压力的显着 WPJ 干预效果。WPJ 和 TAU 在干预后或随访时与其他次要结局没有显著差异。WPJ 的增量成本为 34,202 日元（315.81 美元）。 WPJ 具有成本效益的概率为 74%，育儿压力每改善 1 点，10,000 日元（108.30 美元），92%，20,000 日元（216.60 美元）。该计划以高保真度和出色的保留率交付。结论 WPJ 可以在常规临床护理中以适中的成本提供，对母亲自我报告的健康状况、育儿实践和家庭应对有积极影响。WPJ 是日本 ADHD 社会心理干预的一个有前途的补充。