Home-based SSP on Individuals With PWS

Not Applicable

Terminated

• Conditions: Prader-Willi Syndrome
• Interventions: Behavioral: Safe and Sound Protocol

• Registration Number: NCT03871751
• Lead Sponsor: Indiana University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-02-25
• Study First Submitted QC: 2019-03-11
• Study First Posted: 2019-03-12
• Study Start: 2019-04-08
• Primary Completion: 2019-12-16
• Study Completion: 2019-12-16
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-18
• Last Update Posted: 2022-03-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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)

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Safe and Sound Protocol	Safe and Sound Protocol	All child participants will participate in 1 pre-intervention assessment and 1 post-intervention assessment. The auditory intervention (i.e., Safe and Sound Protocol, SSP) will last for 1 hour per day, for 5 consecutive days.

Primary Outcome Measures

Name	Time	Method
Change from baseline in sensory sensitivities at 1 week	pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention)	Brain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire)

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Foundational Abilities (balance, gross & fine motor control, sensory, social/emotional, auditory/language and attention/organization and sleep) at 1 week	pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention)	Measure of Foundational Abilities (MFA) questionnaire
Change from baseline in prosody at 1 week	pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention)	Prosody assessment of recorded speech
Change from baseline in disruptive behavior at 1 week	pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention)	Developmental Behavior Checklist (DBC2) (questionnaire)
Change from baseline in social behavior at 1 week	post-intervention (within 1 week after intervention)	Safe and Sound Protocol (SSP) Parent Questionnaire

Trial Locations

Locations (1)

Integrated Listening Systems; 🇺🇸 Aurora, Colorado, United States