Tokyo, March 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060846) titled 'Guided Internet-delivered Cognitive Behavioral Therapy for Children with ADHD: A Multicenter Randomized Controlled Trial' on March 6.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - Placebo

Primary Sponsor: Institute - University of Fukui

Condition: Condition - Attention-Deficit/Hyperactivity Disorder Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to evaluate the efficacy and safety of a therapist-guided internet-delivered cognitive behavioral therapy program involving parents for children with attention-deficit/hyperactivity disorder in a multicenter randomized controlled trial. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Therapist-guided internet-delivered cognitive behavioral therapy program Interventions/Control_2 - Sham control program consisting of internet-delivered psychoeducation and related components

Eligibility: Age-lower limit - 6 years-old = Gender - Male and Female Key inclusion criteria - Children Diagnosed with attention-deficit/hyperactivity disorder (ADHD) by a pediatrician or psychiatrist based on DSM-5-TR criteria. Aged 6 to 15 years at the time of consent (elementary or junior high school students). Receiving regular outpatient care at a pediatric or psychiatric clinic. Pharmacological treatment is allowed; however, there are no plans to initiate or change medication during the study period.

Parents Able to read and write Japanese sufficiently to participate in the program. Living with the target child and not planning to move out during the study period. Own and routinely use a computer, tablet, or smartphone. Have access to the internet. Have not received psychosocial interventions for children with neurodevelopmental disorders (e.g., parent training, CBT, social skills training) within the past 12 months. Key exclusion criteria - Children Diagnosis of severe organic brain disease or post-traumatic stress disorder (PTSD). Full-scale IQ (FSIQ) below 80. Severe autism spectrum disorder (ASD) with behavioral difficulties judged to make behavioral modification difficult. Imminent risk of suicide. Currently experiencing school refusal or school absenteeism, including reluctance to attend school, refusal to attend school, or attending a separate classroom. Cases in which child consultation centers, administrative agencies, or social workers are involved, and environmental adjustment or safety management is prioritized.

Parents Presence of serious mental disorders, including organic brain disorders (e.g., intellectual disability or dementia), psychotic disorders, PTSD, or substance dependence. Imminent risk of suicide or significant risk of self-harm or harm to others. Presence of a serious progressive physical illness. Pregnant women, those who may be pregnant, or parents planning pregnancy or childbirth within one year. Target Size - 160

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 12 Month 21 Day Date of IRB - 2026 Year 02 Month 16 Day Anticipated trial start date - 2026 Year 03 Month 10 Day Last follow-up date - 2027 Year 09 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069621

Disclaimer: Curated by HT Syndication.