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April. 08, 2024

April. 08, 2024

jRCT1030240019

Pilot Study of the Effectiveness of Acceptance and Commitment Therapy and Parent Training for Parents of Children with ASD or Suspected ASD.

Effectiveness of Acceptance and Commitment Therapy and Parent Training for Parents.

Okajima Junko

Rikkyo University

12-2-1 Kitano Niizashi Saitama

+81-48-471-7046

jokajima@rikkyo.ac.jp

Okajima Junko

Rikkyo University

26-2-1 Kitano Niizashi

+81-484717046

jokajima@rikkyo.ac.jp

Pending

April. 08, 2024

46

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

other

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.

Those who are unable to attend all programs due to scheduling conflicts at the time of participation.
Those who do not agree to be filmed during the program. (Since the entire program will be filmed, it is not possible to exclude a single person from being filmed.)

No limit
No limit

Both

ASD

There will be a total of seven sessions, each 90 minutes long, including Acceptance and Commitment Therapy and Parent Training content.

ASD, ACT, Parent treaning

D000067877

Stress Index-Short Form (PSI-SF)

Acceptance and Action Questionnaire-II (AAQ-II)
Parental Acceptance and Action Questionnaire (PAAQ)
Adjustment to the Diagnosis of Autism (ADA)
Cognitive Fusion Questionnaire (CFQ-7)
Mindful Attention Awareness Scale (MAAS)
Social Responsiveness Scale-II (SRS-II)
Strength and Diculties Questionnaire (SDQ)
Hospital Anxiety and Depression Scale (HADS)

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

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