UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062417 |
|---|---|
| Receipt number | R000071429 |
| Scientific Title | Psychological adaptation of parents raising infants and young children with Down syndrome and the effects of parenting support: A mixed methods study |
| Date of disclosure of the study information | 2026/08/01 |
| Last modified on | 2026/07/31 11:29:04 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study on how parenting support affects the mental health of parents raising infants and young children with Down syndrome
Acronym
DS Parents Support Study
Scientific Title
Psychological adaptation of parents raising infants and young children with Down syndrome and the effects of parenting support: A mixed methods study
Scientific Title:Acronym
DS Parents Support Study
Region
| Japan |
Condition
Condition
Down syndrome
Classification by specialty
| Pediatrics | Nursing | Adult |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We will assess the psychological state of fathers and mothers, including their emotions and positive feelings toward their children, before and after the intervention. The fathers' and mothers' emotions will be assessed using the Japanese version of the Profile of Mood States, Second Edition, and their positive feelings toward their children will be assessed using the Japanese version of the Maternal Attachment Inventory.
Key secondary outcomes
To assess the developmental status of infants, we will also refer to the Enjoji Analytical Developmental Assessment for Infants and Toddlers, which enables a comprehensive analysis of developmental trends.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver | Other |
Interventions/Control_1
Touching Workshop, Online Social Gathering, Parenting Consultation on Motor Skills and Feeding, Online Couple's Dialogue
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Rie |
| Middle name | |
| Last name | SHINOHARA |
Organization
Kitasato University
Division name
School of Health Sciences Department of Nursing Science
Zip code
9497241
Address
500 Kurotsuchishinden, Minamiuonuma City, Niigata Prefecture
TEL
0257795059
shinohara.rie.nc@st.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Rie |
| Middle name | |
| Last name | Shinohara |
Organization
Kitasato University
Division name
School of Health Sciences Department of Nursing Science
Zip code
9497241
Address
500 Kurotsuchishinden, Minamiuonuma City, Niigata Prefecture
TEL
0257795059
Homepage URL
shinohara.rie.nc@st.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Rie Shinohara
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University
Address
500 Kurotsuchishinden, Minamiuonuma City, Niigata Prefecture
Tel
0257794511
shinohara.rie.nc@st.kitasato-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
| 2027 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 31 | Day |
Last modified on
| 2026 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071429
