Tokyo, Dec. 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060019) titled 'Effects of Clinical Support for Children with Challenging Behaviors' on Dec. 9.

Study Type: Interventional

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

Primary Sponsor: Institute - Kyorin University

Condition: Condition - Children with Challenging Behaviors (school refusal, behavioral disorders including aggressive behaviors, and anxiety disorders including obsessive-compulsive disorder and selective mutism) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to evaluate the effectiveness of clinical interventions, including behavioral therapy, for children exhibiting challenging behaviors such as school refusal, behavioral disorders, and anxiety disorders (including selective mutism), using single-case experimental designs, and to examine the causal relationship between the interventions and behavioral changes in order to identify effective support methods. Basic objectives2 - Others

Intervention: Interventions/Control_1 - The intervention in this study consists of individualized clinical interventions, including behavioral therapy, designed based on ecological assessments of each participant's challenging behaviors. Specifically, behavioral techniques such as token economy procedures, behavioral contracts, and exposure are applied in combination as appropriate to the participant's characteristics and living environment. The intervention procedures are instructed by the researchers and implemented continuously by caregivers in daily life settings such as home and school.

Eligibility: Age-lower limit - 1 years-old = Gender - Male and Female Key inclusion criteria - 1) Children aged 1 to 18 years exhibiting challenging behaviors such as school refusal, behavioral disorders including verbal or physical aggression, or anxiety disorders (including obsessive-compulsive disorder and selective mutism).

2) Caregivers who seek clinical intervention for the child's challenging behaviors.

3) Caregivers who are able to implement the intervention procedures in daily life settings such as home, nursery school, kindergarten, or school in accordance with the researchers' instructions.

4) Caregivers who are capable of appropriately evaluating, recording, and reporting the child's behavioral status to the researchers. Key exclusion criteria - 1) Children who require medical care or intensive medical management due to severe physical and/or intellectual disabilities.

2) Children who are judged by the investigators to be inappropriate for participation in this study for any other clinical or practical reasons. Target Size - 5

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2025 Year 06 Month 12 Day Date of IRB - 2025 Year 06 Month 12 Day Anticipated trial start date - 2025 Year 07 Month 09 Day Last follow-up date - 2027 Year 07 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068640

Disclaimer: Curated by HT Syndication.