Clinical Trial: An Exploratory Study of the CO-OP Approach in a Regional Hospital: Effects, Generalization to Home and School, and Perspectives of Families and Teachers (Japan)

Tokyo, Sept. 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062902) titled 'An Exploratory Study of the CO-OP Approach in a Regional Hospital: Effects, Generalization to Home and School, and Perspectives of Families and Teachers' on Sept. 14.

Study Type: Interventional

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

Primary Sponsor: Institute - Gunma University

Condition: Condition - Developmental disorders Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to examine the feasibility of implementing the CO-OP approach for school-aged children with developmental characteristics in a regional hospital, and to explore changes following the intervention, including how the skills and problem-solving framework acquired through the intervention are applied in daily life at home and school, as well as experiences of collaboration with educational institutions. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - The CO-OP approach will be provided for 60 minutes per session, approximately twice a month, for a total of 10 sessions, to support participants in achieving three self-selected goals.

Eligibility: Age-lower limit - 6 years-old = Gender - Male and Female Key inclusion criteria - Target child School aged children aged 6 to 15 years with developmental characteristics and difficulties in motor coordination, whose parents provide informed consent and who provide assent to participate in the study. Target person Parents and teachers of eligible children who provide informed consent to participate in the study. Key exclusion criteria - Target child Children who have an IQ below 70 on the WISC-V, whose motor difficulties are attributable to underlying conditions such as neuromuscular or degenerative diseases, who have difficulty understanding instructions necessary to perform the tasks, whom the attending physician determines to be unable to participate in the study, or who are continuously receiving occupational therapy at another institution. Target person Those who have difficulty completing the questionnaires or participating in the interviews. Target Size - 45

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2026 Year 09 Month 13 Day Date of IRB - 2026 Year 08 Month 24 Day Anticipated trial start date - 2026 Year 09 Month 14 Day Last follow-up date - 2031 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071748

Disclaimer: Curated by HT Syndication.