JMIR Publications

ABSTRACT

Background:

Attention Deficit Hyperactivity Disorder (ADHD) is a common neurodevelopmental disorder associated with numerous functional deficits and poor long-term outcomes. Internationally, behavioral interventions are recommended as part of a multimodal treatment approach for children with ADHD. Currently in Japan there are limited interventions available targeting ADHD. Well Parent Japan (WPJ), a new hybrid parent training program, provides a culturally acceptable, and effective way to help support Japanese children with ADHD and their parents.

Objective:

This pragmatic multi-center randomised controlled trial will provide preliminary evidence about the effectiveness and cost-effectiveness of WPJ evaluated against treatment as usual (TAU) within routine Japanese mental health services.

Methods:

Mothers of children (6-12 years) diagnosed with ADHD will be recruited from child and adolescent mental health care services at three hospital sites across Japan (Fukui, Fukuoka and Okinawa). Mothers will be randomized to immediate treatment or TAU. The effectiveness and cost effectiveness of WPJ over TAU at the end of intervention and at 3-month follow-up will be evaluated. The primary outcome is maternal Parent Domain stress in the parenting role. The following secondary outcomes will be explored: child behavior, including severity of ADHD symptoms; parenting practices; emotional well-being and the parent-child relationship. Data analysis will follow intention-to-treat principles with treatment effects quantified through ANCOVA by means of multi-level modeling. An incremental cost effectiveness ratio (ICER) will be used to analyse the cost-effectiveness of the WPJ intervention.

Results:

Study funding was secured from a Proof of Concept grant in July 2018. IRB approval for the data collection sites was obtained between 2017 and 2019. Data collection began in August 2019 with expected completion date of January 2022. Subject recruitment (N = 120) was completed in May 2021. Effectiveness and cost-effectivenss analyses are expected to be completed by July 2022 and December 2022 respectively. These timelines are subject to change due to Covid-19.

Conclusions:

This is the first multisite pragmatic trial of WPJ based on the recruitment of children referred directly to routine clinical services in Japan. This multisite randomized trial tests the effectiveness of WPJ with children and families by comparing WPJ directly to the usual clinical care on offer for children diagnosed with ADHD in Japan. We also seek to assess and compare the cost effectiveness of WPJ with TAU in Japan. Clinical Trial: The study was retrospectively registered with ISRCTN after the first of three waves of participant recruitment. Trial registration number: ISRCTN66978270 (https://www.isrctn.com/ISRCTN66978270).