Tokyo, Nov. 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063562) titled 'Development and Feasibility Evaluation of a Compassion Focused Therapy Based Parent Child Program for Adolescents with Neurodevelopmental Disorders and Their Parents' on Nov. 8.

Study Type: Interventional

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

Primary Sponsor: Institute - Chiba University

Condition: Condition - Neurodevelopmental Disorder, Autism Spectrum Disorder,ASD Attention Deficit Hyperactivity Disorder, ADHD Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To examine the feasibility and acceptability of a Compassion Focused Therapy based parent child program for adolescents and young adults with neurodevelopmental disorders and their parents. The study also aims to exploratively evaluate changes in psychological outcomes from baseline to post-intervention and follow-up to assess preliminary signals of intervention efficacy. Basic objectives2 - Others

Intervention: Interventions/Control_1 - A Compassion Focused Therapy based parent child program will be provided to adolescents and young adults with neurodevelopmental disorders and their parents. The program will consist of eight sessions of approximately 50 minutes each. Sessions will generally be conducted online. Based on the principles of CFT, the program will include psychoeducation on compassion, awareness of self criticism, and exercises to cultivate a compassionate mind.

Eligibility: Age-lower limit - 13 years-old = Gender - Male and Female Key inclusion criteria - 1.Individuals who meet the DSM-5 diagnostic criteria for a neurodevelopmental disorder. 2.Children aged 13 to 24 years at the time of consent and their parents. There is no age restriction for parents. 3.Individuals who have obtained permission to participate from their attending physician. 4.Individuals with sufficient language ability to participate in the program. 5.Individuals who have received sufficient explanation of the study, fully understood it, and provided written informed consent voluntarily. 6.Individuals experiencing difficulties related to the child's maladaptive behaviors at home, school,including school non-attendance, or other settings. 7.For online participation, individuals who have internet access at home and are able to participate continuously in the online intervention. Key exclusion criteria - 1.Individuals with a severe mental disorder, such as a psychotic disorder, bipolar disorder, or substance-related disorder according to DSM-5, for whom discontinuation of the study is 2.anticipated due to worsening symptoms. 3.Individuals who do not provide informed consent after receiving and understanding a sufficient explanation of the study, or who refuse the use of their information for research purposes. 4.Individuals with a serious progressive physical illness for whom discontinuation of the study is anticipated. 5.Individuals judged by the principal investigator or study psychologist to be unsuitable for safe participation in the study. 6.Individuals receiving other active treatments, such as cognitive behavioral therapy, during the study period. Target Size - 10

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 08 Month 26 Day Date of IRB - 2025 Year 10 Month 01 Day Anticipated trial start date - 2026 Year 01 Month 08 Day Last follow-up date - 2026 Year 02 Month 28 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071601

Disclaimer: Curated by HT Syndication.