UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030802 |
|---|---|
| Receipt number | R000034420 |
| Scientific Title | Assessing the Effectiveness and Safety of Safe and Sound Protocol for Adults and Adolescence of Autism Spectrum Disorder |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2023/11/08 13:09:08 |
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Basic information
Public title
Assessing the Effectiveness and Safety of Safe and Sound Protocol for Adults and Adolescence of Autism Spectrum Disorder
Acronym
Assessing the Effectiveness and SSP for Adults and Adolescence of Autism Spectrum Disorder
Scientific Title
Assessing the Effectiveness and Safety of Safe and Sound Protocol for Adults and Adolescence of Autism Spectrum Disorder
Scientific Title:Acronym
Assessing the Effectiveness and SSP for Adults and Adolescence of Autism Spectrum Disorder
Region
| Japan |
Condition
Condition
Autism Spectrum Disorder from age 19 to 50
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The Safe & Sound Protocol (SSP) is a creative intervention based on the polyvagal theory for improving impairments in social communication by reducing auditory hypersensitivity and improving human speech processing (Associate Manual Safe & Sound Protocol. The SSP rehabilitates the function of middle ear muscles using filtered music adjusted to fit the specific frequency of human speech. The SSP thus improves social communication associated with auditory processing (Associate Manual Safe & Sound Protocol). Previous studies of children with ASD who used an early version of SSP reported significant improvements in their auditory problems, including auditory processing, listening, and hearing sensitivities This study aimed to evaluate, first, the effectiveness of SSP for social communication, auditory hypersensitivity, and psychiatric symptoms in adults with ASD.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
The second edition of the widely administered Social Responsiveness Scale
Key secondary outcomes
Comparison before, and immediately after and 1 month after the intervention of
1. CES-D;Center for Epidemiological Studies Depression Scale
2. STAI;State-Trait Anxiety Inventory
3. SP;Sensory Profile
4. WHO Quality of Life 26
5. HRV;Heart Rate Variation
6. FaceReader
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Using Safe and Sound Protocol 1 hour/day for 5days
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
| 19 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Diagnosed with ASD using ADOS-2 by research team
2. Subject hasn't experienced Listening Therapy
3. Obtaining written informed consent
4. Outpatient of Okayama University Hospital
Key exclusion criteria
1. Diagnosed with schizophrenia or bipolar disorder
2. Serious neurological or physical condition
3. Neurodevelopmental disorders of known genetic etiology
4. History of epilepsy
5. Diagnosed with PTSD (post-traumatic stress disorder) by medical institution in the past
6. Subject Have been undergone intensive cognitive behavior therapy within 6
months
7. Participant who were judged to be unsuitable for the study by the study investigator.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Norihito |
| Middle name | |
| Last name | Yamada |
Organization
Okayama University Hospital
Division name
Department of Neuropsychiatry
Zip code
7008558
Address
2-5-1 Shikata-cho Kita-ward Okayama City OKayama
TEL
086-235-7242
nyamada@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Makiko |
| Middle name | |
| Last name | Kishimoto |
Organization
Okayama University Hospital
Division name
Department of Neuropsychiatry
Zip code
7008558
Address
2-5-1 Shikata-cho Kita-ward Okayama City OKayama
TEL
0862357241
Homepage URL
kishimoto-m@ncchd.go.jp
Sponsor or person
Institute
Okayama University Hospital Department of Neuropsychiatry
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University Hospital
Address
2-5-1 Shikata-cho Kita-ward Okayama City OKayama
Tel
0862357241
kishimoto-m@ncchd.go.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
岡山大学病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/36981773/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/36981773/
Number of participants that the trial has enrolled
6
Results
In this study, there were no significant differences in the total scores of SRS-2 across all time-points. Only SRS-2 Family-Report showed a significant improvement after the intervention. In addition, it was significantly correlated with physical health of WHOQOL-BREF (r = -0.577, p = 0.012), state and trait anxiety of STAI (r = 0.576, p = 0.012; r = 0.708, p = 0.00009), and CES-D (r = 0.465, p = 0.05).
Results date posted
| 2023 | Year | 11 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Six participants with ASD aged 21 to 44 years (average age 27.1 years) were recruited from the outpatient Department of Neuropsychiatry of Okayama University Hospital. All participants were Japanese and diagnosed with ASD based on the ADOS-2 (Autism Diagnostic Observation Schedule, Second Edition).
Participant flow
Thid participants were recruited from Outpatient clinic of Okayama University Hospital. Before the study, all participants provided informed written consent.
Age, marital status, employment status, education, country of birth, and medical history were collected in face-to-face interviews to confirm that all participants met the inclusion and exclusion criteria.
Adverse events
None
Outcome measures
The effects were evaluated using the Social Responsiveness Scale, Second Edition (SRS-2), as the main criteria. The secondary outcomes were determined using the Center for Epidemiological Studies Depression Scale, State-Trait Anxiety Inventory, WHO Quality of Life 26, Adolescent/Adult Sensory Profile, and heart rate variability.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2018 | Year | 04 | Month | 08 | Day |
Date analysis concluded
| 2018 | Year | 06 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 14 | Day |
Last modified on
| 2023 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034420
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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