Clinical Trial: The Listening Project at Reiss-Davis/Vista Del Mar Child and Family Services

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The Listening Project at Reiss-Davis/Vista Del Mar Child and Family Services

Brief Summary: A research project funded by the Reiss-Davis Child Study Center of Vista Del Mar (RDCSC/VDM) will be conducted on the Vista Del Mar campus of the RDCSC/VDM to evaluate the effectiveness of the Listening Project Protocol (LPP) in children who have difficulties with autonomic and behavior regulation in the classroom. The LPP is designed as a "neural exercise" to reduce auditory hypersensitivities, to improve auditory processing of speech, and to improve behavioral state regulation. The LPP uses acoustic stimulation to exercise the neural regulation of the middle ear structures to rehabilitate and to normalize the acoustic transfer function of the middle ear structures. The current study is being conducted to evaluate efficacy and feasibility of the LPP with emotionally disturbed and learning challenged young people and will use objective measures to evaluate changes in acoustic transfer function of the middle ears structures, auditory processing skills, physiological state regulation, sensory symptoms, and academic pre and post testing.

Detailed Summary:
Sponsor: University of North Carolina, Chapel Hill

Current Primary Outcome: Change from baseline in auditory hypersensitivity at 1 week, and at 2 months [ Time Frame: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), 2 months post-intervention ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from baseline in state regulation at 1 week, and at 2 months [ Time Frame: pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 2 months post-intervention ]
    heart rate, heart period, high-frequency heart rate variability/respiratory sinus arrhythmia
  • Change from baseline in auditory processing at 1 week, and at 2 months [ Time Frame: pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 2 months post-intervention ]
    filtered words, competing words subscales of SCAN
  • Change from baseline in social behavior at 1 week, and at 2 months [ Time Frame: post-intervention (within 1 week after the intervention), 2 months post-intervention ]
    Listening Project Parent Questionnaire
  • Change from baseline in middle ear transfer function at 1 week, and at 2 months [ Time Frame: post-intervention (within 1 week after the intervention), 2 months post-intervention ]
    Middle Ear Sound Absorption System (MESAS)


Original Secondary Outcome: Same as current

Information By: University of North Carolina, Chapel Hill

Dates:
Date Received: March 16, 2015
Date Started: October 2015
Date Completion: April 2017
Last Updated: May 4, 2016
Last Verified: May 2016