Tokyo, July 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062225) titled 'Feasibility Study of an Online Psychoeducation Program for Parents of Adolescents with Neurodevelopmental Disorders' on July 13.

Study Type: Interventional

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

Primary Sponsor: Institute - Chiba University

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

Objective: Narrative objectives1 - The aim of this study is to pilot an on-demand psychoeducational program comprising web-based psychoeducational videos incorporating elements of CBT and CFT for caregivers of adolescents with neurodevelopmental disorders, including autism spectrum disorder and attention-deficit/hyperactivity disorder, and to evaluate its feasibility and acceptability. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - This study targets caregivers, rather than children with diagnosed neurodevelopmental disorders (NDDs) who are receiving care at medical institutions. All samples and information collected in this study will be provided by the caregivers. At the time of application, only the following information will be collected: telephone number, email address, whether the child has been diagnosed with autism spectrum disorder (ASD) or attention-deficit/hyperactivity disorder (ADHD), and responses to the questionnaires used for screening. For applicants who meet the eligibility criteria and are enrolled in the study, background information including the caregiver's sex and age, as well as the sex and age of the target child, will be collected. Thereafter, participants will complete psychological scales and other questionnaires using Google Forms at three time points: before the intervention (video viewing) begins (Pre), at the end of the intervention period (Post), and two weeks after the end of the intervention period (Follow-up). During the study period, information sharing with participants, including communication, guidance, and handling inquiries, will be conducted through a study-specific LINE group.

Eligibility: Age-lower limit - 29 years-old = Gender - Male and Female Key inclusion criteria - Caregivers of children aged 11-17 years who have been diagnosed with autism spectrum disorder (ASD) or attention-deficit/hyperactivity disorder (ADHD) Individuals who have internet access at home and are able to use the LINE app and view on-demand videos Individuals who, after receiving a sufficient explanation about participation in this study and fully understanding its contents, provide written informed consent of their own free will Key exclusion criteria - Individuals who are currently receiving treatment for a psychiatric disorder This refers to cases in which the participating caregiver is currently receiving treatment for a psychiatric disorder. Individuals whose child in the eligible age range does not have a diagnosis of autism spectrum disorder (ASD) or attention-deficit/hyperactivity disorder (ADHD) This includes cases in which the child is suspected of having ASD or ADHD but has not received a diagnosis, or cases in which the caregiver has a child aged 11-17 years, but the diagnosed child is a sibling outside the eligible age range. Individuals whose child has a diagnosis of ASD or ADHD but does not meet the cutoff scores on the screening questionnaires described below Individuals from whom consent cannot be obtained Individuals whom the principal investigator otherwise judges to be unsuitable for participation Target Size - 30

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 06 Month 15 Day Date of IRB - 2026 Year 06 Month 15 Day Anticipated trial start date - 2026 Year 06 Month 16 Day Last follow-up date - 2026 Year 10 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070390

Disclaimer: Curated by HT Syndication.