An interventional study of Safe and Sound Protocol in Prader-Willi Syndrome, sponsored by Indiana University. Terminated at 1 site in United States. Open to participants aged 3 Years to 17 Years. Per ClinicalTrials.gov, last updated 2022-03-07.
Sponsored by Indiana University · Not applicable, Interventional, and Basic science
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.
142 studies on the registry are indexed under Prader-Willi Syndrome; 23 are open to participants now.
This study's enrollment of 10 is below the median of 30 across 99 interventional studies indexed under Prader-Willi Syndrome.
Browse Prader-Willi Syndrome studies →Indiana University is the lead sponsor of 982 studies on the registry; 199 are open to participants now.
Of its 148 completed or terminated interventional studies of FDA-regulated products, 117 (79%) have results posted.
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Exclusion Criteria:
1) Child participants who are hearing-impaired (without correction)
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.
Behavioral: Safe and Sound Protocol
The auditory intervention will consist of listening to computer-altered acoustic stimulation, designed to modulate the frequency band of vocal music passed to the participant. The frequency characteristics of the acoustic stimulation are selected to emphasize the relative importance of specific frequencies in conveying the information embedded in human speech. Modulation of the acoustic energy within the frequencies of human voice, similar to an exaggerated vocal prosody, are hypothesized to recruit and modulate the neural regulation of the middle ear muscles and to functionally reduce sound hypersensitivities and improve auditory processing.
Also known as: Listening Project Protocol
Change from baseline in sensory sensitivities at 1 week
Brain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire)
Time frame: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention)
Change from baseline in disruptive behavior at 1 week
Developmental Behavior Checklist (DBC2) (questionnaire)
Time frame: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention)
Change from baseline in social behavior at 1 week
Safe and Sound Protocol (SSP) Parent Questionnaire
Time frame: post-intervention (within 1 week after intervention)
Change from baseline in Foundational Abilities (balance, gross & fine motor control, sensory, social/emotional, auditory/language and attention/organization and sleep) at 1 week
Measure of Foundational Abilities (MFA) questionnaire
Time frame: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention)
Change from baseline in prosody at 1 week
Prosody assessment of recorded speech
Time frame: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention)
Plan to share: No
Ran from Apr 2019 to primary completion in Dec 2019, 8 months.
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This study is terminated, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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