The effect of Universal Unified Prevention Program for Diverse Disorders(UP2-D2) on students' behavior and noncognitive skills

Last registered on March 15, 2023


Trial Information

General Information

The effect of Universal Unified Prevention Program for Diverse Disorders(UP2-D2) on students' behavior and noncognitive skills
Initial registration date
June 24, 2022

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
June 26, 2022, 5:28 AM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Last updated
March 15, 2023, 9:32 PM EDT

Last updated is the most recent time when changes to the trial's registration were published.


Primary Investigator

Keio University

Other Primary Investigator(s)

PI Affiliation
University of Tokyo
PI Affiliation
Kyoto University
PI Affiliation
Doshisha University

Additional Trial Information

In development
Start date
End date
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
With the widespread of the Covid-19, school-aged children experienced temporary school closures, cancellations and postponements of school events and/or extracurricular activities, and a decrease in oral communication in school. According to the the survey conducted by Saitama Prefecture, 21.1% of schools stopped interactive activities among students and 90.1% of school events and/or extracurricular activities had to be cancelled or postponed. Research showed that 26.0 to 34.5% of school-aged children experienced high levels of anxiety (Ma et al., 2021; Panda et al., 2020). In fact, at the end of the 2020 school year, the number of children who were not attending school in elementary schools in Saitama Prefecture was 2,624, a 23.7% increase from the previous year. The number of cases of bullying was also reached at 22,613, an increase of 19.6% from the previous year. Given this situation, there is a growing awareness of the importance of education that addresses problems in a "preventive" manner. In this study, we implement "Universal Unified Prevention Program for Diverse Disorders (hereafter, UP2-D2)", developed by Prof. Shinichi Ishikawa (one of the investigators) and measure the causal effects of children's behaviors, such as bullying, violence, and truancy, and non-cognitive skills, such as self-efficacy and prosociality.
Our target is approximately 6,152 of fourth to sixth graders at 38 public elementary schools in five cities in Saitama Prefecture, which is located in Kanto metropolitan areas in Japan. We will administer a baseline survey to all children in June 2022. Based on this baseline survey, students will be randomly assigned to treatment or control groups at school-by-grade level (114 clusters). From the second semester, which begins in September, teachers will execute the UP2-D2 program during the regular class hours with in total 9 hours (=45 minutes * 12 lessons). The follow-up and endline survey will be conducted at March, 2023 and March, 2024.
We are allowed to use administrative data that Saitama prefecture administered every April, which include IRT based students' achievements.
External Link(s)

Registration Citation

Ishikawa, Shinichi et al. 2023. "The effect of Universal Unified Prevention Program for Diverse Disorders(UP2-D2) on students' behavior and noncognitive skills." AEA RCT Registry. March 15.
Sponsors & Partners


Experimental Details


One of the coauthors (Ishikawa) developed a new school-based universal prevention program (Universal Unified Prevention Program for Diverse Disorders, Up2-D2), which targets transdiagnostic mental health problems based on a cognitive-behavioral approach in schools. The Up2-D2 aims at broad-band effects on mental health problems in elementary school students aged 8–15 years. The Up2-D2 was designed to integrate common components in CBT for children and adolescents based on evidence-based psychosocial interventions, such as psychoeducation, behavioral activation, social skills training, relaxation, cognitive restructuring, gradual exposure, and problem-solving.
Intervention Start Date
Intervention End Date

Primary Outcomes

Primary Outcomes (end points)
The numbers of violence, bullying, and truancy at school, students' self-efficacy and pro-sociality
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
Student achievements
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
Our randomization is conducted at the grade-by-school level. We randomly assign 114 grades at 38 public elementary schools intro treatment or control groups (in 2022FY) and 75 grades at 25 public elementary schools (in 2023 FY).
Experimental Design Details
Randomization Method
Randomization done in office by a computer, based on baseline survey.
Randomization Unit
Was the treatment clustered?

Experiment Characteristics

Sample size: planned number of clusters
114 grades (in 2022 FY) and 75 grades (in 2023 FY)
Sample size: planned number of observations
6,152 students (in FY2022) and 5,096 students (in FY2023)
Sample size (or number of clusters) by treatment arms
38 clusters with 2,050 students (in FY2022) and 37 clusters with 2325 students (in FY2023)
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Based on ICC (0.01-0.02), significance p=0.05, effect size=0.2, statistical power=0.80, we need at least 10 clusters.

Institutional Review Boards (IRBs)

IRB Name
Keio University
IRB Approval Date
IRB Approval Number
IRB Name
Keio University
IRB Approval Date
IRB Approval Number


Post Trial Information

Study Withdrawal

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Is the intervention completed?
Data Collection Complete
Data Publication

Data Publication

Is public data available?

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials