Tokyo, March 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060494) titled 'Introduction of a Child-Rearing Support App for Parents of Children with Developmental Disabilities in a Population Approach-Oriented Region' on March 1.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - International University of Health and Welfare

Condition: Condition - neurodevelopmental disorder/Developmental disorder Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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.

Eligibility: Age-lower limit - 18 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 Size - 150

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 03 Month 31 Day Anticipated trial start date - 2026 Year 04 Month 01 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069202

Disclaimer: Curated by HT Syndication.