Clinical trial NCT03871751: Home-based SSP on Individuals With PWS
Official title: Evaluating the Effectiveness of Home-based SSP on Individuals With PWS
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prader-Willi Syndrome
Keywords: Polyvagal Theory
Social Behavior
Hyperacusis
Prosody
Auditory intervention
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Integrated Listening Systems
First posted: 2019-03-12
Enrollment: 10
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will receive the auditory intervention.
Primary purpose: BASIC_SCIENCE

Brief summary: The Polyvagal Theory focuses on how function and structure changed in the vertebrate autonomic nervous system during evolution. The theory is named for the vagus, a major cranial nerve that regulates bodily state. As a function of evolution, humans and other mammals have a "new" vagal pathway that links the regulation of bodily state to the control of the muscles of the face and head including the middle ear muscles. These pathways regulating body state, facial gesture, listening (i.e., middle ear muscles), and vocal communication collectively function as a Social Engagement System (SES). Because the Social Engagement System is an integrated system, interventions influencing one component of this system (e.g., middle ear muscles) may impact on the other components.

Individuals with Prader-Willi Syndrome (PWS) exhibit many behaviors that are consistent with a compromised Social Engagement System. Atypical function of the Social Engagement System results in problems associated with state regulation (e.g., impulsivity, tantrums, and difficulty with change in routine), ingestion (e.g., difficulties in sucking at birth, hyperphagia), coordination of suck/swallow/breathe, intonation of vocalizations, auditory processing and hypersensitivity, and socialization. The investigatiors propose to confirm that several features of the behavioral phenotype of PWS may be explained within the context of a dysfunctional SES, which may be partially rehabilitated via an intervention designed as a 'neural exercise' of the SES (i.e., the Safe and Sound Protocol, "SSP").

Specific Aims:

Aim I: To demonstrate the effectiveness of the Safe and Sound Protocol (SSP) on improvement of social and regulation behaviors in individuals with PWS.

Aim II: To evaluate a new methodology for collecting and evaluating vocal samples for analyses of prosody, one of the indices of the functioning of the SES.


Eligibility criteria: Inclusion Criteria:

1. Child participants must meet criteria for Prader-Willi Syndrome (per parent membership in Prader-Willi Parent Support Group).
2. Child participants must be between ages 3-17 years. Parent must be 18 years or older.
3. Child participants must have normal hearing (confirmed via parental report on Qualtrics questionnaire)

Exclusion Criteria:

1) Child participants who are hearing-impaired (without correction)

Primary outcomes:
measure: Change from baseline in sensory sensitivities at 1 week
timeFrame: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention)
Secondary outcomes:
measure: Change from baseline in disruptive behavior at 1 week
timeFrame: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention)
measure: Change from baseline in social behavior at 1 week
timeFrame: post-intervention (within 1 week after intervention)
measure: Change from baseline in Foundational Abilities (balance, gross & fine motor control, sensory, social/emotional, auditory/language and attention/organization and sleep) at 1 week
timeFrame: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention)
measure: Change from baseline in prosody at 1 week
timeFrame: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention)
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Integrated Listening Systems
state: Colorado
Study officials:
affiliation: Indiana University/Kinsey Institute
name: Jacek Kolacz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Porges SW. The polyvagal theory: phylogenetic substrates of a social nervous system. Int J Psychophysiol. 2001 Oct;42(2):123-46. doi: 10.1016/s0167-8760(01)00162-3.
citation: 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.