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Guided Internet-delivered Cognitive Behavioral Therapy for Children with ADHD: A Multicenter Randomized Controlled Trial

Guided Internet-delivered Cognitive Behavioral Therapy for Children with ADHD: A Multicenter Randomized Controlled Trial - Guided ICBT for Children with ADHD

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000060846
Enrollment
160
Registered
2026-03-06
Start date
2026-03-10
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention-Deficit/Hyperactivity Disorder

Interventions

Therapist-guided internet-delivered cognitive behavioral therapy program Sham control program consisting of internet-delivered psychoeducation and related components

Sponsors

University of Fukui
Lead Sponsor
Chiba University Dokkyo Medical University Saitama Medical Center Tokyo Medical University Jichi Medical University Nagoya City University Osaka University Tokushima University Kagoshima University Hiratani Child Development Clinic Linkoping University
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Change in ADHD symptom severity based on the parent-rated ADHD Rating Scale-5 total score

Secondary

MeasureTime frame
ADHD Rating Scale-5: Inattention and Hyperactivity-Impulsivity SNABB: ADHD monitoring scale SDQ: Strengths and Difficulties Questionnaire DSRS-C: Depression Self-Rating Scale for Children SCAS: Spence Children's Anxiety Scale Conners 3: Conners 3rd Edition PSI-SF: Parenting Stress Index-Short Form PHQ-9: Patient Health Questionnaire-9 GAD-7: Generalized Anxiety Disorder-7 WAI-SF: Working Alliance Inventory-Short Form CSQ-8: Client Satisfaction Questionnaire-8 CGI: Clinical Global Impression

Countries

Japan,Europe

Contacts

Public ContactSayo Hamatani

University of Fukui Research Center for Child Mental Development

sayoh@u-fukui.ac.jp0776-61-8707

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026