UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058412 |
|---|---|
| Receipt number | R000066714 |
| Scientific Title | Evaluating the Effectiveness of Trauma-Informed Care Training for Foster Parents |
| Date of disclosure of the study information | 2025/11/01 |
| Last modified on | 2025/10/31 15:49:27 |
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Basic information
Public title
Evaluating the Effectiveness of Trauma-Informed Care Training for Foster Parents
Acronym
Evaluating the Effectiveness of Trauma-Informed Care Training for Foster Parents
Scientific Title
Evaluating the Effectiveness of Trauma-Informed Care Training for Foster Parents
Scientific Title:Acronym
Evaluating the Effectiveness of Trauma-Informed Care Training for Foster Parents
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study has two main objectives.
First, it aims to clarify the impact of Trauma-Informed Care (TIC) training on foster parents' confidence in their TIC-related abilities, their implementation of TIC practices, their Quality of Life (QOL), and their well-being. Furthermore, it seeks to determine if the magnitude of these effects differs based on the foster parents' own Adverse Childhood Experiences (ACEs).
Second, using baseline data, this study aims to clarify the association between the foster child's difficulties and the foster parent's QOL (encompassing secondary traumatic stress, burnout, and compassion satisfaction) and well-being. It will also investigate whether the strength of this association is moderated by the foster parents' ACEs.
By examining the relationship with children's difficulties and the differential effects of parental ACEs, this research can contribute to identifying the specific groups that require more substantial support and help inform what kind of assistance is necessary.
To capture both the positive and negative aspects of the foster parenting experience, this study includes open-ended questions, although these will not be part of the quantitative analysis. The free-text responses will ask about joys and happy experiences, difficulties and challenges, and the motivations for becoming a foster parent. The intention is to incorporate these qualitative insights into the discussion for a more comprehensive interpretation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measure: Scale for Trauma-Considerate Parenting (Trauma-Informed Care Provider Survey)
A total of 27 items from the survey will be used, comprising the following subscales:
Knowledge of Trauma-Informed Care (11 items)
Self-Rated Competence (10 items)
Recent Practice (7 items)
Measurements will be taken at three time points:
Pre-intervention (before the intervention)
Immediately to one month post-intervention
Four months post-intervention
Key secondary outcomes
Foster Parent's Quality of Life (QOL): Measured using the Japanese version of the Professional Quality of Life Scale (ProQOL).
Compassion Fatigue (Secondary Traumatic Stress), Compassion Satisfaction, and Burnout.
Foster Parent's Psychological Well-being: Measured using the Japanese short form of the Mental Health Continuum (MHC-SF).
Emotional Well-being (3 items), Social Well-being (5 items), and Psychological Well-being (6 items).
Foster Child's Emotional and Behavioral Difficulties: Measured using the Japanese version of the Strengths and Difficulties Questionnaire (SDQ).
Emotional Problems, Conduct Problems, Hyperactivity/Inattention, Peer Relationship Problems, and Prosocial Behavior.
Foster Parent's Isolation:
Interaction with fellow foster parents and foster parent associations.
Socializing with friends.
Satisfaction with Related Agencies and Services:
Perceived lack of information about the foster child.
Satisfaction with related agencies and services.
Workplace supportiveness.
Open-Ended Questions (Free-text Responses):
Difficulties or challenges experienced in caregiving.
Positive or happy experiences in caregiving.
Motivation for becoming a foster parent.
Variables for Interaction Effects Assessment:
Foster Parent's ACEs: Measured using the Adverse Childhood Experiences (ACEs) survey for Japanese.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
A video training and workshop on Trauma-Informed Care.
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
Foster and adoptive parents in Japan who are currently raising foster or adopted children
Key exclusion criteria
Foster and adoptive parents who are not currently caring for foster or adopted children
Target sample size
791
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Nishi |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Mental Health
Zip code
1130033
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-5841-3364
d-nishi@m.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Kaho |
| Middle name | |
| Last name | Katase |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Psychiatric Nursing
Zip code
1130033
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-5841-3364
Homepage URL
kaho-k1011@g.ecc.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
The University of Tokyo
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Institute of Science Tokyo
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Office for Human Research Studies(OHRS) Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033 JAPAN
Tel
03-5841-0818
ethics@m.u-tokyo.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
| 2025 | Year | 11 | 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
| 2025 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 09 | Day |
Last modified on
| 2025 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066714
