Tokyo, Aug. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062417) titled 'A study on how parenting support affects the mental health of parents raising infants and young children with Down syndrome' on Aug. 1.

Study Type: Interventional

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

Primary Sponsor: Institute - Kitasato University

Condition: Condition - Down syndrome Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective is to implement a support program including parenting support and parent-child relationship support for fathers and mothers of infants and toddlers with Down syndrome, and to identify its effectiveness and challenges. Based on data collected from both fathers' and mothers' perspectives, the study aims to identify the challenges and support needs faced by families from infancy through early childhood, and to clarify specific strategies for parenting support and parent-child relationship support for families with infants and toddlers with Down syndrome, as well as future challenges. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Touching Workshop, Online Social Gathering, Parenting Consultation on Motor Skills and Feeding, Online Couple's Dialogue

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - This study targets fathers and mothers of children with Down syndrome who are between 2 months and under 2 years of age. Since children with Down syndrome often have comorbid conditions, no selection criteria regarding health impairments will be established in order to conduct a broad survey of their actual circumstances. Taking into account the impact of the child-rearing environment on parent-child relationships, the selection criterion is that neither the father nor the mother has a health impairment requiring regular medical treatment. Key exclusion criteria - No exclusion criteria based on family background or other factors will be established. Target Size - 40

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 29 Day Date of IRB - 2026 Year 07 Month 29 Day Anticipated trial start date - 2026 Year 08 Month 01 Day Last follow-up date - 2027 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071429

Disclaimer: Curated by HT Syndication.