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April. 08, 2024 |
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April. 08, 2024 |
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jRCT1030240019 |
Pilot Study of the Effectiveness of Acceptance and Commitment Therapy and Parent Training for Parents of Children with ASD or Suspected ASD. |
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Effectiveness of Acceptance and Commitment Therapy and Parent Training for Parents. |
Okajima Junko |
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Rikkyo University |
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12-2-1 Kitano Niizashi Saitama |
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+81-48-471-7046 |
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jokajima@rikkyo.ac.jp |
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Okajima Junko |
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Rikkyo University |
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26-2-1 Kitano Niizashi |
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+81-484717046 |
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jokajima@rikkyo.ac.jp |
Pending |
April. 08, 2024 |
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| 46 | ||
Interventional |
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single arm study |
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open(masking not used) |
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uncontrolled control |
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single assignment |
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other |
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Parents and their children who are struggling with their relationship with their children. The child must be between 1.5 and 13 years of age. The child may or may not have a diagnosis of Autism Spectrum Disorder (ASD), but must be able to consent to an assessment using psychological testing and assessment tools such as the ADOS-2 regarding the child's characteristics. Be willing to fill out and complete a total of 5 questionnaires before, after, 3 months, and at 6 and 12 months of follow-up program participation. |
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Those who are unable to attend all programs due to scheduling conflicts at the time of participation. |
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| No limit | ||
| No limit | ||
Both |
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ASD |
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There will be a total of seven sessions, each 90 minutes long, including Acceptance and Commitment Therapy and Parent Training content. |
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ASD, ACT, Parent treaning |
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D000067877 |
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Stress Index-Short Form (PSI-SF) |
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Acceptance and Action Questionnaire-II (AAQ-II) |
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| none |
| NEC Solution Innovator, Ltd. | |
| Not applicable |
| Secretariat of the Ethics and Safety Committee for Research and Experiments Related to Life Sciences, Rikkyo University | |
| 26-2-1 Kitano Niizashi, Saitama | |
| lifescience@rikkyo.ac.jp | |
| Approval | |
Mar. 22, 2024 |
Yes |
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Storage location: 1, (inspection form), 2, (paper questionnaire), 4, Room 6704, 7th floor, Building 6, Niiza Campus, Rikkyo University 1, (numerical result data), 2, (data), 3, (photographed data), 5, (scanned data): Google Drive managed by rikkyo account Storage period/method: The collected data will be kept for 10 years after the publication of the study. (1) Inspection forms, (2) questionnaires (paper questionnaires), and (4) consent forms will be kept in a locked cabinet at the above storage location. At that time, the forms (1) and (2) should be separated from personal information by writing the ID number on the forms (1) and (2), but not the name. The numerical result data in (1), the questionnaire data in (2), the photographed data in (3), the scanned data in (5), and the corresponding table should be stored on a drive under security control. Other considerations such as leakage prevention: (1) Whether and how access control or information access is restricted The drive where data is stored is restricted to Rikkyo University account holders only, and access is restricted to the experiment conductors and assistants. In addition, the room for managing paper media in a cabinet is the principal investigator's laboratory, and entry is limited to the principal investigator and the faculty members who are sharing the room. The research room shall be locked at all times when the principal investigator is not present. (2) Recording media to be used and whether or not recording media are taken out of the room The SD card will be taken out to bring it back to the storage location (Okajima Laboratory) from the implementation site, but will not be taken out for any other reason. After the photographed data are stored on the drive, the information on the SD card should be erased immediately. |
none |