Tokyo, Oct. 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059508) titled 'Effectiveness Study of the Circle of Security Parenting (COSP) Program for Children with Neurodevelopmental Disorders and Their Caregivers' on Oct. 22.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Non-randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - Kansai University of Welfare Sciences

Condition: Condition - Neurodevelopmental Disorders Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study will implement the Circle of Security Parenting (COSP) program for caregivers of children with neurodevelopmental disorders and evaluate over a six-month observation period, changes in children's behavioral problems and improvements in parental responsiveness, parenting self-efficacy, and parenting stress levels. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - The intervention group will participate in the eight-session Circle of Security Parenting (COSP) program, with each session lasting approximately 120 minutes and conducted on a weekly basis. Interventions/Control_2 - No treatment

Eligibility: Age-lower limit - 6 years-old = Gender - Male and Female Key inclusion criteria - Children (Intervention/Non-Intervention Groups) 1. Children with a primary diagnosis of a neurodevelopmental disorder 2. Aged between 6 and 12 years at the time of study participation 3. Receiving outpatient care at a medical institution

Caregivers (Intervention Group) 1. Able to participate in all eight COSP sessions 2. Provided written informed consent after receiving a full explanation of the study and demonstrating sufficient understanding of its content, based on their own free will.

Caregivers (Non-Intervention Group) 1. Caregivers of children aged 6-12 years with a primary diagnosis of a neurodevelopmental disorder 2. Received a written invitation describing the study objectives, procedures, potential benefits and risks, contact information, and ethical considerations, and agreed to participate by returning a signed consent form. Key exclusion criteria - Children 1) Receiving 90 min total or more per week of intensive intervention therapy or psychotherapy, or if they began or changed a pharmacotherapeutic regimen during the study period.

Caregivers 1) Caregivers with a mental illness or developmental disability, or who had been reported to the juvenile welfare officer for perpetrating severe child abuse. 2) Previous or ongoing participation in a COSP-based psychological program at the time of study enrollment. Target Size - 55

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2025 Year 06 Month 20 Day Date of IRB - 2025 Year 08 Month 26 Day Anticipated trial start date - 2025 Year 10 Month 01 Day Last follow-up date - 2029 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068068

Disclaimer: Curated by HT Syndication.