Tokyo, Aug. 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062614) titled 'A Study of the Feasibility and Effectiveness of a Home-Visiting Parenting Support Program' on Aug. 19.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - Tokyo Gakugei University

Condition: Condition - Parenting stress and parenting difficulties among parents of infants and preschool-aged children Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to evaluate, using an individually randomized controlled trial, whether home-visiting parenting programs offered through the 3-year-old child health checkup reduce parenting stress and parenting difficulties. Based on each family's support needs, participating families receive one of the following parenting programs: CARE, SafeCare, Watch Me Play!, or Triple P. Outcomes are compared with those of the control group. The study also examines acceptability, ease of participation and continuation, participant burden, and conditions relevant to implementing the programs in community-based parenting support services. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Intervention group: Based on each family's support needs, one of the following home-visiting parenting programs is provided: CARE, SafeCare, Watch Me Play!, or Triple P. The program is delivered by a trained home visitor. Each session lasts approximately 60 minutes, with a total of 5 to 10 sessions. Interventions/Control_2 - Wait-list control group: Families do not receive the study-provided home-visiting parenting program during the 12-week period after T0 but may continue to use usual municipal, medical, and welfare services. After completing the T1 assessment at 12 weeks after T0, families are offered the parenting program selected according to their support needs.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Families are eligible if all of the following criteria are met: The family resides in Koganei City. The questionnaire respondent is the child's father or mother and is aged 18 years or older at the time informed consent is obtained. The target child is between birth and entry into elementary school at the time informed consent is obtained. If there is more than one child in the family, the parent is able to identify one child as the target child whom they primarily wish to discuss and support through the program. The questionnaire respondent is able to understand the study information provided in Japanese and provide written informed consent to participate. The questionnaire respondent is able to complete the questionnaires and interviews in Japanese. The family is able to receive the parenting program through face-to-face home visits. Key exclusion criteria - Families are excluded if any of the following criteria apply: At the time of study enrollment, staff members of the Child and Family Center and the principal investigator determine that urgent administrative, medical, psychological, or social welfare support should take priority over research participation. The family has previously received or is currently receiving any of the following programs: CARE, SafeCare, Level 3 Primary Care Triple P, or Watch Me Play! Staff members of the Child and Family Center and the principal investigator determine that face-to-face home visits cannot be conducted while ensuring the safety of the participant and the home visitor. The principal investigator determines that participation is inappropriate because the assessments or intervention specified in the study protocol cannot reasonably be conducted. Target Size - 100

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 06 Month 30 Day Date of IRB - 2026 Year 07 Month 29 Day Anticipated trial start date - 2026 Year 08 Month 09 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071673

Disclaimer: Curated by HT Syndication.