Assessing the Effectiveness and Safety of Safe and Sound Protocol for Adults and Adolescence of Autism Spectrum Disorder

Assessing the Effectiveness and Safety of Safe and Sound Protocol for Adults and Adolescence of Autism Spectrum Disorder - Assessing the Effectiveness and SSP for Adults and Adolescence of Autism Spectrum Disorder

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000030802

Enrollment

Registered

2018-04-01

Start date

2018-01-20

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder from age 19 to 50

Interventions

Using Safe and Sound Protocol 1 hour/day for 5days

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
The second edition of the widely administered Social Responsiveness Scale	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactMakiko Kishimoto

Okayama University Hospital Department of Neuropsychiatry

kishimoto-m@ncchd.go.jp0862357241

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026