UMIN-CTR Clinical Trial

Public title

Examination of effective practice method for mothers of parenting program CARE in community health field - Randomized controlled trial -

Acronym

Examination of effective practice method of parenting program CARE - Randomized controlled trial -

Scientific Title

Examination of effective practice method for mothers of parenting program CARE in community health field - Randomized controlled trial -

Scientific Title:Acronym

Examination of effective practice method of parenting program CARE - Randomized controlled trial -

Region

Japan

Condition

No

Classification by specialty

Nursing

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is to examine the effective implementation method of the Child-Adult Relationship Enhancement Program (CARE) in community health and to clarify the influence on children and mothers.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Child's problem behavior

Key secondary outcomes

Mother's parenting stress, depression, child care skills, cognition and behavior for child rearing, inappropriate child maltreatment

Study type

Interventional

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

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Implementation of the CARE (Child-Adult Relationship Enhancement) program 1
3.5 hours
Workshop to train child care methods

Implementation of the CARE (Child-Adult Relationship Enhancement) program 2
2.5 hours
Workshop to train child care methods

Implementation of follow-up program
1.5 hours
Review and group work

Interventions/Control_2

Waiting List

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 have a child (2 years old - elementary school fourth grade at the time of program participation), satisfy all of the following criteria
(1) When she agrees to participate in all schedules of CARE program (including preliminary survey and post-survey).
(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 (not including lecture for 3 hours) 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

122

Name of lead principal investigator

1st name	Hitoe
Middle name
Last name	Kimura

Organization

Faculty of Medical Sciences, Kyushu University

Division name

Department of Health Sciences

Zip code

812-8582

Address

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

TEL

092-642-6707

Email

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

Name of contact person

1st name	Hitoe
Middle name
Last name	Kimura

Organization

Faculty of Medical Sciences, Kyushu University

Division name

Department of Health Sciences

Zip code

812-8582

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

Co-sponsor

Name of secondary funder(s)

Organization

Kyushu University Hospital Research ethics committee

Address

3-1-1, Maidashi, Higashi-ku, Fukuoka City

Tel

092-642-6707

Email

kimura.hitoe.935@m.kyushu-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

04

Month

27

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

Completed

Date of protocol fixation

2018

Year

03

Month

30

Day

Date of IRB

2018

Year

03

Month

30

Day

Anticipated trial start date

2018

Year

06

Month

30

Day

Last follow-up date

2022

Year

07

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

04

Month

27

Day

Last modified on

2022

Year

12

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036724