Tokyo, Oct. 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063252) titled 'TOP Program Treasure Is Outdoor Play Program An Outdoor Play Based Parent and Child Mental Health Program for Elementary School Children and Their Parents' on Oct. 13.

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 - developmental characteristics Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to evaluate the effectiveness of the TOP Program, a parent and child mental health program that combines outdoor play and psychoeducational videos for elementary school children and their parents. The program is designed to support children's emotional regulation, communication skills, and overall strengths, while enhancing parents' understanding of developmental characteristics and their coping skills for parenting-related stress. Children with and without developmental characteristics will participate in the same program, and the study will compare the effectiveness of the program and any differences in outcomes between these groups. The program aims to promote and maintain the mental wellbeing of both children and their parents. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Participants in the intervention group will receive a two-week intervention consisting of: (1) viewing online psychoeducational videos, (2) participating in an outdoor play program conducted on a weekend at the study site under the supervision of researchers and local collaborators, and (3) engaging in parent-child outdoor play activities at home for two weeks. During the intervention period, children will wear a wearable device to collect physiological data, including heart rate and sleep patterns. In addition to questionnaire assessments, salivary cortisol will be measured as a stress-related biomarker. Following completion of the program, a psychologist will conduct a semi-structured interview. Assessments will be conducted immediately after the intervention and again at 1-month and 3-month follow-up points.

Eligibility: Age-lower limit - 6 years-old

Gender - Male and Female Key inclusion criteria - Children with Developmental Characteristics Children who have been diagnosed with Autism Spectrum Disorder (ASD) or Attention-Deficit/Hyperactivity Disorder (ADHD) by a physician. Children who score at or above the cutoff value on the Autism-Spectrum Quotient (AQ) (20 points or higher) and/or at or above the cutoff value on the ADHD Rating Scale (ADHD-RS, Child Version). (Children meeting either one or both of the above criteria will be included in this group.) Children without Developmental Characteristics Children who have not been diagnosed with ASD or ADHD by a physician. Children who score below the cutoff value on the AQ (less than 20 points) and below the cutoff value on the ADHD Rating Scale (ADHD-RS, Child Version). Children who score below the cutoff value on the AQ (<20 points) and below the cutoff value on the ADHD-RS (Child Version). Key exclusion criteria - Individuals for whom informed consent cannot be obtained after receiving a full explanation of the study, or whose parent/legal guardian refuses the use of their information for research purposes.

Individuals with severe physical or psychiatric disorders that would prevent them from completing the study questionnaires.

Individuals who have been instructed by a physician to restrict physical activity, or those with an acute illness, serious medical history, or other conditions that the Principal Investigator considers unsuitable for participation in the study.

Individuals deemed inappropriate for participation in the study for any other reason at the discretion of the researchers. Target Size - 24

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 09 Month 01 Day Date of IRB - 2026 Year 09 Month 30 Day Anticipated trial start date - 2026 Year 10 Month 10 Day Last follow-up date - 2027 Year 01 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072398

Disclaimer: Curated by HT Syndication.