UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053825 |
|---|---|
| Receipt number | R000061402 |
| Scientific Title | Objective Study of the Effects of CARE Program Intervention on Parents of Children with Developmental Disorders Using Brain Function and Salivary Hormones |
| Date of disclosure of the study information | 2024/03/12 |
| Last modified on | 2024/03/11 11:52:04 |
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Basic information
Public title
Objective Study of the Effects of CARE Program Intervention on Parents of Children with Developmental Disorders Using Brain Function and Salivary Hormones
Acronym
Objective Study of the CARE Program for Parents of Children with Developmental Disorders
Scientific Title
Objective Study of the Effects of CARE Program Intervention on Parents of Children with Developmental Disorders Using Brain Function and Salivary Hormones
Scientific Title:Acronym
Objective Study of the CARE Program for Parents of Children with Developmental Disorders
Region
| Japan |
Condition
Condition
Autism Spectrum Disorder/Attention Deficit Hyperactivity Disorder/Children/Adult
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to objectively examine the effects of a usual Child Adult Relationship Enhancement (referred as CARE) program for parents of children with developmental disorders (ASD/ADHD) and a CARE program with psychoeducation for developmental disorders, using parent-child brain function measurements and salivary hormone levels.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare the effects of the programme intervention between the usual CARE group and the CARE programme group with developmental psychoeducation, using fNIRS and salivary hormone concentration measurements pre/post the intervention.
Key secondary outcomes
Parent: Socio-economic status, Problematic behaviors of the child, Child's developmental tendencies, Behavioral coding during roll-play, parental depression, parental personality traits, level of CARE practice, impression of child.
Child: Intellectual development, depressive tendencies, anxiety, traumatic experiences, symptoms, strength and difficulties, impression of parent.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
CARE program1 implimentation2 hours. Workshops to learn how to interact at the child's pace
CARE program2 implimentation2 hours. Workshops to learn how to appropriately dealing with child's problematic behavior and give instructions
Follow up implimentation1 hour. Review of CARE program practices and sharing of feedback
Interventions/Control_2
CARE program1 implimentation2 hours. Workshops to learn how to interact at the child's pace, with developmental psychoeducation
CARE program2 implimentation2 hours. Workshops to learn how to appropriately dealing with child's behavioral problems and give instructions, including developmental psychoeducation
Follow up implimentation1 hour. Review of CARE program practices and sharing of feedback
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
| 6 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Children with ASD and ADHD from first to sixth grade and their parents
2.Child's intellectual development is above a full scale IQ of 75
3.Written consent to participate in this study will be obtained from the child and parents
4.Parents must be at least 20 years old and native Japanese speaker or able to understand Japanese and speaking fluently
Key exclusion criteria
1.Children and their parents who do not meet the above inclusion criteria
2.When the child and parent are judged to be inappropriate as a subject by the doctor's judgment
3.If it is known in advance that the participants will not be able to continue to participate in the study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Sakae |
| Middle name | G |
| Last name | Mizushima |
Organization
Kitasato University
Division name
Graduate School of Medical Sciences Department of Developmental Psychiatry
Zip code
2520373
Address
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
TEL
0427787957
mizushima.sakae@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Sakae |
| Middle name | G |
| Last name | Mizushi |
Organization
Kitasato University Graduate School of Medical Sciences
Division name
Department of Developmental Psychiatry
Zip code
2520373
Address
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
TEL
0427787957
Homepage URL
mizushima.sakae@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Kitasato University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Japan Society for the Promotion of Science
IRB Contact (For public release)
Organization
Kitasato University Hospital
Address
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
Tel
0427788111
rinrib@med.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
北里大学病院（神奈川県）、北里大学大学院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 12 | 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
| 2024 | Year | 01 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 11 | Day |
Last modified on
| 2024 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061402
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