UMIN-CTR Clinical Trial

Public title

Introduction of a Child-Rearing Support App for Parents of Children with Developmental Disabilities in a Population Approach-Oriented Region

Acronym

Research on a Support System for Parenting Challenges

Scientific Title

The Impact of an ICT-Based Parenting Support System on Parental Difficulties and Psychological Burden: An Intervention Study in Local Governments

Scientific Title:Acronym

Parenting Support System using ICT

Region

Japan

Condition

neurodevelopmental disorder/Developmental disorder

Classification by specialty

Pediatrics

Psychiatry

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is to modify the "Problem-Solving System mama and..." which has been suggested as a potential aid in supporting individuals with developmental disabilities - and introduce it into local government childcare support programs. This aims to enhance support and increase reassurance for parents experiencing difficulties in childcare, regardless of whether their child has a developmental disability, while also establishing a sustainable support system that connects parents and support providers.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The following information will be collected: 1) Usage status (viewed content, number of views), 2) Usage details and usefulness before and after use (survey: participants needs and opinions via 4 point scale and open ended comments), 3) Effectiveness (3 psychological assessments: PSI SF Parenting Stress Index Short Form, Japanese version of ECBI Eiburg Child Behavior Inventory, PACAP Parenting Assessment in Contemporary Environments).

Key secondary outcomes

The following information will be collected within one month before 1 and after 2 the system launch. 1 Basic information survey Child attributes age gender current social participation status Parent attributes age gender family composition employment status other details 2 App usage confirmation survey 20 items total.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

The primary purpose and outcome measure is the utilization of the Parenting Support App mama and .... Therefore after providing research explanations and obtaining consent from participants and after they complete basic attribute responses information about the Parenting Support App mama and ... will be provided. Participation will commence at that point and last for 3 months 90 days total. During this period participants are asked to use the Parenting Support App mama and ... as needed.

After research consent and before system use begins and again within one month after the three month usage period participants will complete three types of questionnaires and effectiveness assessments PSI SF Japanese version ECBI and PACAP. The study will conclude upon completion of these assessments.

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

70

years-old

>=

Gender

Male and Female

Key inclusion criteria

This study involves 1 A total of 50 parents of preschool aged children who use the outpatient department at Nasu Therapy Center and have received occupational therapy prescriptions from physicians. Participants must currently face parenting challenges and express interest in this app. 2 A total of 100 parents of children who have completed their 3 and 5 year old health checkups in the four municipalities of Nakagawa Town Nasu Town Otawara City and Nasushiobara City. Participants must currently experience difficulties in childcare or have interest in this app. The number of participants was determined by consulting with the system engineer regarding the maximum number of users the current server could handle during the trial period of the Childcare Support App mama and ... tentative name. It also considered the number of preschool children using Nasu Therapeutic Education Center and the populations of municipalities of different sizes Nasu Town 24000 residents Nasushiobara City 120000 residents Otawara City 80000 residents Nakagawa Town 13000 residents who have completed their 3 and 5 year old health checkups and the number of support providers.

Key exclusion criteria

Selection criteria Participants will be excluded if they do not meet the following conditions primarily based on the content listed above. 1 Nasu Therapeutic Care Center users Preschool aged children with an occupational therapy prescription whose parents have not previously used this system. Local municipalities Parents residing in Nasu Town Nasushiobara City Otawara City or Nakagawa Town who have completed the 3 and 5 year old health checkups or parents facing childcare difficulties in surrounding areas. 2 Request period From ethics review approval until 6 months later. 3 Individuals currently experiencing difficulties in childcare or those interested in this app. 4 Individuals from whom written consent for voluntary research participation can be obtained. Exclusion criteria apply to individuals who do not meet any one of the four selection criteria listed above 1 to 4.

Target sample size

150

Name of lead principal investigator

1st name	HIDENOBU
Middle name
Last name	SEKIMORI

Organization

International University of Health and Welfare

Division name

Faculty of Health Sciences, Department of Occupational Therapy

Zip code

3248501

Address

2600-1 Kitakanamaru, Otawara City, Tochigi, Japan

TEL

0287243015

Email

hsekimori@ihwg.jp

Name of contact person

1st name	HIDENOBU
Middle name
Last name	SEKIMORI

Organization

International University of Health and Welfare

Division name

Faculty of Health Sciences, Department of Occupational Therapy

Zip code

3248501

Address

2600-1 Kitakanamaru, Otawara City, Tochigi, Japan

TEL

0287243015

Homepage URL

Email

hsekiori@ihwg.jp

Institute

International University of Health and Welfare

Institute

Department

Personal name

Organization

Japan Science and Technology Agency

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

International University of Health and Welfare

Address

2600-1 Kitakanamaru, Otawara City, Tochigi, Japan

Tel

0287243015

Email

hsekimori@ihwg.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

03

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

03

Month

31

Day

Date of IRB

Anticipated trial start date

2026

Year

04

Month

01

Day

Last follow-up date

2028

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

01

Month

28

Day

Last modified on

2026

Year

01

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069202