UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023172 |
|---|---|
| Receipt number | R000026669 |
| Scientific Title | Developing mental health guidance guidelines for school nurses to assist parents in handling adolescence-related problems |
| Date of disclosure of the study information | 2016/07/30 |
| Last modified on | 2025/01/21 09:21:01 |
* 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
Developing mental health guidance guidelines for school nurses to assist parents in handling adolescence-related problems
Acronym
Developing mental health guidance guidelines for parents of adolescents
Scientific Title
Developing mental health guidance guidelines for school nurses to assist parents in handling adolescence-related problems
Scientific Title:Acronym
Developing mental health guidance guidelines for parents of adolescents
Region
| Japan |
Condition
Condition
Healthy individual
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Developing mental health guidance guidelines for school nurses to assist parents in handling adolescence-related problems.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Help-seeking research
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Parents of junior high school, Intervention group n2000, Non-intervention group n2000, Evaluated after 1 week
Interventions/Control_2
Parents of junior high school, Intervention group n2000, Non-intervention group n2000, Evaluated after 1 week
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Parents of junior high school students
Key exclusion criteria
Other than that
Target sample size
4000
Research contact person
Name of lead principal investigator
| 1st name | Hatsumi |
| Middle name | - |
| Last name | Yoshii |
Organization
Tohoku University
Division name
School of Health Sciences, Faculty of Medicine
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai-City, Miyagi-Prefecture, 980-8575 Japan
TEL
022-717-7954
hatsumi@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Hatsumi |
| Middle name | - |
| Last name | Yoshii |
Organization
Tohoku University
Division name
School of Health Sciences, Faculty of Medicine
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai-City, Miyagi-Prefecture, 980-8575 Japan
TEL
022-717-7954
Homepage URL
hatsumi@med.tohoku.ac.jp
Sponsor or person
Institute
School of Health Sciences, Faculty of Medicine, Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Japan educational mutual aid association of welfare foundation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University Graduate School of Medicine Ethics Committee
Address
2-1 seiryo-machi, Aoba-ku,Sendai-City, Japan
Tel
0227178007
med-kenkyo@grp.tohoku.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
| 2016 | Year | 07 | Month | 30 | Day |
Related information
URL releasing protocol
file:///C:/Users/%E5%90%89%E4%BA%95%E5%88%9D%E7%BE%8E/Downloads/%E6%80%9D%E6%98%A5%E6%9C%9F%E3%83%97
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/eip.13390
Number of participants that the trial has enrolled
2496
Results
There were no between-group differences in changes in the rate of no help-seeking in any hypothetical situations of a child's psychosis and prodromal symptoms.
Results date posted
| 2025 | Year | 01 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 2496 parents of first-grade junior high school students, recruited from a Japan-based survey company, participated in a randomized controlled trial in July 2016; participants were randomly allocated to the intervention (n = 1248) or control group (n = 1248).
Participant flow
They were assessed at baseline and one-week post intervention. The intervention group received a 30-minute online educational programme that included a narrative of the mother of an adolescent with psychosis.
Adverse events
none
Outcome measures
Help-seeking attitudes towards mental healthcare services for the child's mental health issues was also measured by 10 items adapted from the Japanese version of the Attitudes Towards Seeking Professional Psychological Help Short Form (ATSPPH-SF) (Sato et al., 2014).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 06 | Month | 29 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 14 | Day |
Last modified on
| 2025 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026669
