UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041306 |
|---|---|
| Receipt number | R000047162 |
| Scientific Title | Effectiveness of online health guidance program based on cognitive behavioral therapy(CBT for Parent to Support Accepting Children's Uniqueness: CBT-PAC)for parent to understand children with autism spectrum tendency and deal with parenting stress:A pilot study |
| Date of disclosure of the study information | 2020/09/01 |
| Last modified on | 2025/02/02 17:06:10 |
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Basic information
Public title
Effectiveness of online health guidance program based on cognitive behavioral therapy(CBT for Parent to Support Accepting Children's Uniqueness: CBT-PAC)for parent to understand children with autism spectrum tendency and deal with parenting stress:A pilot study
Acronym
CBT-PAC
Scientific Title
Effectiveness of online health guidance program based on cognitive behavioral therapy(CBT for Parent to Support Accepting Children's Uniqueness: CBT-PAC)for parent to understand children with autism spectrum tendency and deal with parenting stress:A pilot study
Scientific Title:Acronym
CBT-PAC
Region
| Japan |
Condition
Condition
A parent of child with suspected Autism spectrum
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effectiveness of online health guidance CBT program for parenting resilience of parents with suspected autism spectrum child aged 2 to under 7 by the single arm pilot study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Development and Evaluation of a Parenting Resilience Elements Questionnaire(PREQ)
Key secondary outcomes
(1)Parenting Stress Index(PSI)
(2)The General Health Questionnaire(GHQ-28)
(3)State-Trait Anxiety Inventory-JYZ(STAI)
(4)Eyberg Child Behavior Inventory(ECBI)
(5)Ministry of Health, Labor and Welfare Maternal and Child Health Guidelines Healthy Parents and Children 21(Secondary)Question 4 items
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
The health guidance using cognitive behavioral model
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)A parent with child aged between 2 to under7
(2)Child met ASD criteria in M-CHAT or SRS-2
(3)Individual with the score above"190.6"in PSI.
(4)Indivudal who falls under any of the following:"has no died/self-harm consideration,"has not" or "has had a moment"in GHQ-28.
(5)Individual who understands the explanation and has consent.
(6)Individual who have an access to internet and computer environment
(7)Individual taking health guidance from the government and not planned to start a new drug therapy (psychiatric field)during the test period.
(8)Individual have a mental and physical condition enough to take the program continuously.
(9)Individual who have not received other cognitive behavioral therapy during the study period.
(10)Individual who can participate in the weekly CBT program.
Key exclusion criteria
1) Individual with who have an organic disorder,have serious psychicalpsycical disorder.(in five years)
2) Individual who have low IQ(under 89 of VIQ)
3)individual who are receiving medical treatment in psychiatry.
4)Individual with antisocial conditions.
5) Individual with serious psychical disorder.
6)Individual who is judged inappropriate to participate by the researchers
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Shimizu |
Organization
Chiba University
Division name
Research Center for Child Mental Development; Department of Cognitive Behavioral Physiology; Cognitive Behavioral Therapy Center
Zip code
260-8670
Address
1-8-1, Inohana, Chuo Ward, Chiba-shi, Chiba , Japan
TEL
043-226-2028
eiji@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Kawasaki |
Organization
Chiba University
Division name
Research Center for Child Mental Development
Zip code
260-8670
Address
1-8-1, Inohana, Chuo Ward, Chiba-shi, Chiba , Japan
TEL
043-226-2028
Homepage URL
tomoko-kawasaki.rengo@chiba-u.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science/MEXT(Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University Hospital
Address
1-8-1, Inohana, Chuo Ward, Chiba-shi, Chiba 260-8670, Japan
Tel
043-222-7171
prc-jim@chiba-u.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
G2020015
Org. issuing International ID_1
Chiba University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
千葉大学医学部附属病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
https://kaken.nii.ac.jp/report/KAKENHI-PROJECT-20K10986/20K109862020hokoku/
Publication of results
Unpublished
Result
URL related to results and publications
https://kaken.nii.ac.jp/ja/report/KAKENHI-PROJECT-20K10986/20K10986seika/
Number of participants that the trial has enrolled
26
Results
As a result, there were significant differences in the increase in scores for parenting resilience (PREQ total15.5(SD9.70),Cohen d 1.38,P<.0001), the decrease in scores for the mental health of parents (higher scores indicate poorer mental health), the decrease in anxiety scores for parents, and the decrease in scores for parents perceiving their children's problematic behavior as a problem.In addition,these results were maintained one month after the intervention (week10).
Results date posted
| 2025 | Year | 02 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The children were 19 boys and 7 girls, with an average age of 51.1 months (SD 14.87). All of the participating parents were mothers, with an average age of 36.5 years (SD 3.94), and 18 of them were employed.
All of the participants were married.
Participant flow
From 2020 to 2022,the CBT-PAC program (CBT-PAC), a health guidance program based on a cognitive behavioral model developed by the principal investigator and others, was implemented in a single group of 26 cases at Chiba University Hospital.
Participants were required to meet the following criteria
The child must score 60 or more on the Social Responsiveness Scale Second Edition (SRS-2).
The child must score 190.6 or more on the Parenting Stress Index (Japanese version) (PSI).
In item 28 of the General Health Questionnaire (GHQ-28), the subject answered never had suicidal thoughts, had no suicidal thoughts,or had suicidal thoughts for a moment.
Adverse events
No adverse events were observed.
Outcome measures
The primary evaluation item is the change in the Development and Evaluation of a Parenting Resilience Elements Questionnaire (PREQ) (self-administered) from the baseline (week 0) to immediately after the program (week 6).As secondary evaluation items, the following were used: the three lower items of the PREQ (Positive perception of parenting, Knowledge of the child's characteristics, Perceived social supports), the PSI total score, the lower items of the PSI (Parent's side, Child's side), the GHQ-28, the lower items of the State-Trait Anxiety Inventory-JYZ (STAI) (State anxiety, Characteristic), and the Eyberg Child Behavior Inventory (ECBI) sub-items Intensity and Problems (self-assessment).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 06 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 04 | Day |
Last modified on
| 2025 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047162
