Online Parent-Report Evaluation of the Effects of Processed Music

NCT05249270 | Terminated

• 1 other identifier: 1912463776
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to examine effectiveness of the Safe and Sound Protocol (SSP) on sensory, digestive, and eating behaviors in children currently receiving therapy.

Conditions

Sensory Disorders; Sensory Processing Disorder; Autism Spectrum Disorder; Eating Disorders; Gastro-Intestinal Disorder; Swallowing Disorder; Anxiety

Outcome Measures

Primary Outcomes (1)

• Sensory sensitivities

  Brain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire)

  Change from baseline to 1 and 4 week post assessment

Secondary Outcomes (3)

• Selective eating

  Change from baseline to 1 and 4 week post assessment

• Ingestive problems

  Change from baseline to 1 and 4 week post assessment

• Digestive problems

  Change from baseline to 1 and 4 week post assessment

Study Arms (1)

Safe and Sound Protocol Participants

Parents of children receiving the Safe and Sound Protocol (a clinical auditory therapy provided outside of the study) will complete questionnaires to assess sensory behaviors prior to therapy initiation (baseline), 1 week after therapy conclusion, and 4 weeks after therapy conclusion. The SSP typically consists of 1 hour of listening per day, for 5 consecutive days. If modifications of the typical dosage are implemented due to client needs, they will be documented by parents in the 1 week post therapy questionnaire.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Parents or legal guardians of children who are receiving the Safe and Sound Protocol at Children's Therapy of Woodinville (in Woodinville, WA)

You may qualify if:

• Parent or legal guardian of child who is receiving the Safe and Sound Protocol at Children's Therapy of Woodinville (in Woodinville, WA)
• Parent must be 18 years or older

Sponsors & Collaborators

• Indiana University: lead
• Children's Therapy of Woodinville: collaborator

Study Sites (1)

Children's Therapy of Woodinville

Woodinville, Washington, 98072, United States

Location

Related Publications (2)

• Porges SW, Bazhenova OV, Bal E, Carlson N, Sorokin Y, Heilman KJ, Cook EH, Lewis GF. Reducing auditory hypersensitivities in autistic spectrum disorder: preliminary findings evaluating the listening project protocol. Front Pediatr. 2014 Aug 1;2:80. doi: 10.3389/fped.2014.00080. eCollection 2014.

  PMID: 25136545 BACKGROUND

• Porges SW, Macellaio M, Stanfill SD, McCue K, Lewis GF, Harden ER, Handelman M, Denver J, Bazhenova OV, Heilman KJ. Respiratory sinus arrhythmia and auditory processing in autism: modifiable deficits of an integrated social engagement system? Int J Psychophysiol. 2013 Jun;88(3):261-70. doi: 10.1016/j.ijpsycho.2012.11.009. Epub 2012 Nov 29.

  PMID: 23201146 BACKGROUND

MeSH Terms

Conditions

Sensation Disorders; Autism Spectrum Disorder; Feeding and Eating Disorders; Digestive System Diseases; Deglutition Disorders; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Signs and Symptoms, Digestive; Esophageal Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Research Scientist

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: February 21, 2022
• Study Start: March 22, 2020
• Primary Completion: June 28, 2022
• Study Completion: June 28, 2022
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)