A pragmatic randomised controlled trial of the effectiveness and cost‐effectiveness of Well Parent Japan in routine care in Japan: The training and nurturing support for mothers (TRANSFORM) study

Abstract

BackgroundWell 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.MethodsTRANSFORM 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.ResultsWPJ 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.ConclusionsWPJ 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.