UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation for effect of CARE (Child-Adult Relationship Enhancement) in local community to reduce child's problem behaviors.
Title of the study (Brief title)	Investigation for effect of CARE for child's problem behaviors.
Region	Japan

Condition
Condition	None
Classification by specialty	Nursing Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to investigate for effect of CARE in local community to reduce child's problem behaviors.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Child's problem behaviors are evaluated by ECBI (Eyberg Chiled Behavior Inventory) at before the intervention, 4 weeks and 8 weeks after the intervention.
Key secondary outcomes	Parenting stress for mothers are evaluated by PSI-SF (Parenting Stress Index Short Form) at before the intervention, 4 weeks and 8 weeks after the intervention.

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	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Operation of CARE program This study is prospective study. (1)Method of implementation Implementation term is 12 weeks. Participants are separeted to Participants group and Waiting list group by using median values of child's problematic behavior and stress of child care. CARE program is operated to Participants group and results are compared between Paticipants group and Waiting list group. After CARE program is operated to Participants group (4 weeks after), the program is operated to Waiting list group too. In this term, we follow up to Particpants group to evaluate the effectiveness of the program. (2) Number of program implementation and patricapnts CARE program is operated once (3.5 hours). Two weeks after,we mail to participants to encourage operation for CARE program. Number of participants per program are paritcipants group: 24, and Waiting list group: 24
Interventions/Control_2	Follow up is operated to each group after 4 weeks and 8 weeks for each group. Operation time is 1.5 hours per follow up.
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	64 years-old >=
Gender	Female
Key inclusion criteria	Healthy mother who hopes to deepen the bond of mother and her child and decrease the problem behaviors of the young child (at the time of program participation 2 years old - 6 years old), and meets a the following standards. (1) When she agrees to participation in all CARE program schedules(including a feasibility study and the subsequent study). (2)When she can communicate in Japanese enough and does not have a trouble in decision making . (3) When she agrees by a document,and she is 20 years old - 64 years old. (4)When she participates in CARE program for the first time.
Key exclusion criteria	The person who corresponds to the following standards in one. (1)When she experiences a serious life event (the death of the near relation and severe disease) within a half year from a feasibility study. (2)When the researchers judge that she is ill-qualified.
Target sample size	100

Research contact person
Name of lead principal investigator	Hitoe Kimura
Organization	Faculty of Medical Sciences, Kyushu University
Division name	Department of Health Sciences
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka City, 812-8582 Japan
TEL	092-642-6707
Email	h-kimura@med.kyushu-u.ac.jp

Public contact
Name of contact person	Hitoe Kimura
Organization	Faculty of Medical Sciences, Kyushu University
Division name	Department of Health Sciences
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka City, 812-8582 Japan
TEL	092-642-6707
Homepage URL
Email	h-kimura@med.kyushu-u.ac.jp

Sponsor
Institute	Kyushu University
Institute
Department

Funding Source
Organization	Japan Society for The Promotion of Science Grants-in-Aid for Scientific Reserch
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	大野城市こども健康課

Other administrative information
Date of disclosure of the study information	2015 Year 11 Month 13 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 10 Month 30 Day
Anticipated trial start date	2015 Year 12 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 11 Month 13 Day
Last modified on	2018 Year 01 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022589