UMIN-CTR Clinical Trial

Public title

Investigation for effect of CARE (Child-Adult Relationship Enhancement) in local community to reduce child's problem behaviors.

Acronym

Investigation for effect of CARE for child's problem behaviors.

Scientific Title

Investigation for effect of CARE (Child-Adult Relationship Enhancement) in local community to reduce child's problem behaviors.

Scientific Title:Acronym

Investigation for effect of CARE for child's problem behaviors.

Region

Japan

Condition

None

Classification by specialty

Nursing

Adult

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

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

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Hitoe Kimura

Organization

Faculty of Medical Sciences, Kyushu University

Division name

Department of Health Sciences

Zip code

Address

3-1-1, Maidashi, Higashi-ku, Fukuoka City, 812-8582 Japan

TEL

092-642-6707

Email

h-kimura@med.kyushu-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Hitoe Kimura

Organization

Faculty of Medical Sciences, Kyushu University

Division name

Department of Health Sciences

Zip code

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

Institute

Kyushu University

Institute

Department

Personal name

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

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

大野城市こども健康課

Date of disclosure of the study information

2015

Year

11

Month

13

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

No longer recruiting

Date of protocol fixation

2015

Year

10

Month

30

Day

Date of IRB

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

Other related information

Registered date

2015

Year

11

Month

13

Day

Last modified on

2018

Year

01

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022589