UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052319 |
|---|---|
| Receipt number | R000045900 |
| Scientific Title | Effectiveness of smartphone behavior activation, assertion training, and problem-solving therapy for parenting stress of parents raising children with autism spectrum disorder: Multicenter, randomized, open-label, parallel group comparison trial |
| Date of disclosure of the study information | 2023/10/01 |
| Last modified on | 2024/02/22 19:57:27 |
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Basic information
Public title
Effectiveness of smartphone behavior activation, assertion training, and problem-solving therapy for parenting stress of parents raising children with autism spectrum disorder: Multicenter, randomized, open-label, parallel group comparison trial
Acronym
Effectiveness of smartphone behavior activation, assertion training, and problem-solving therapy for parenting stress of parents raising children with autism spectrum disorder
Scientific Title
Effectiveness of smartphone behavior activation, assertion training, and problem-solving therapy for parenting stress of parents raising children with autism spectrum disorder: Multicenter, randomized, open-label, parallel group comparison trial
Scientific Title:Acronym
Effectiveness of smartphone behavior activation, assertion training, and problem-solving therapy for parenting stress of parents raising children with autism spectrum disorder
Region
| Japan |
Condition
Condition
Parents raising children with autism spectrum disorder in elementary and junior high school students
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate whether behavioral activation , assertion training, problem solving therapy.using smartphones improves depression, anxiety, cognitive behavior therapy skills, and presentism in parents of children with autism spectrum disorder in elementary and junior high school students.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Depressive symptoms measured at week 8 with a self-filled Personal Health Questinnaire-9 (PHQ-9)
Key secondary outcomes
1) PHQ-9 at 1, 2, 3, 4, 5, 6, 7, 12, 16 weeks
2) Generalized Anxiety Disorder-7 (GAD-7) at 4th and 8th weeks
3) Cognitive behavioral therapy skills at 8 weeks
4) Presentism scale at 8 weeks
5) Usage status of smartphone apps
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
NO
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
Complete the psychoeducation component within 2 weeks of consent. For the intervention group, behavior activation, assertion training, and problem-solving therapy are performed for 6 weeks on the smartphone using the "My heart care regitre!" App.The secretariat sends a message (constant text) of encouragement to advance the smartphone application by email every week until the 8th week. Only information about the number of times the app is used and how long it is used is recorded on the server using Google analytics (not the personal details on the sheet in the app). If there are inquiries about usage, we will respond by e-mail or telephone as appropriate.
Interventions/Control_2
Complete the psychoeducation component within 2 weeks of consent. No action is taken until the 8th week. We will provide the same "behavior activation + assertion training + problem solving therapy" application as the intervention group to those who responded to the survey in the 8th week.
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
| 24 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Parents between the ages of 24 and under 60 who are caring for a child with autism spectrum disorder among elementary and junior high school students between the ages of 6 and 16 and are smartphone users.
Key exclusion criteria
Those who have difficulty in reading and writing Japanese, or who have uncontrolled serious mental illness that is inappropriate for participation, or who are judged to be inappropriate for participation by the child or participant's own doctor.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Atsurou |
| Middle name | |
| Last name | Yamada |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Psychiatry and Cognitive-Behavioral Medicine
Zip code
467-8601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL
0528515511
atsurou@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Atsurou |
| Middle name | |
| Last name | Yamada |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Psychiatry and Cognitive-Behavioral Medicine
Zip code
467-8601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL
0528515511
Homepage URL
atsurou@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Mie Prefectural Children's Psychosomatic Development Medical Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Management Center, Nagoya City University Hospital
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
Tel
052-858-7215
clinical_research@med.nagoya-cu.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
名古屋市立大学病院、三重県立子ども心身発達医療センター
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 01 | 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
Completed
Date of protocol fixation
| 2020 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 15 | Day |
Date of closure to data entry
| 2023 | Year | 09 | Month | 15 | Day |
Date trial data considered complete
| 2023 | Year | 09 | Month | 15 | Day |
Date analysis concluded
| 2023 | Year | 09 | Month | 27 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 27 | Day |
Last modified on
| 2024 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045900
