Autism Spectrum Disorder Clinical Trial
Official title:
Treatment for Auditory Hyper-Reactivity Behavior in Children With Autism Using Exposure and Response Prevention Principles
Verified date | June 2019 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Auditory hyper-reactivity affects up to 66% of children with autism spectrum disorder (ASD) and has been linked to greater stress and anxiety for children and their families. Exposure and Response Prevention (E/RP) is highly effective for reducing obsessive/compulsive behaviors in children with both OCD and ASD. This study is the first to assess the feasibility and efficacy of E/RP for auditory sensory hyper-reactivity in ASD.
Status | Completed |
Enrollment | 5 |
Est. completion date | May 31, 2019 |
Est. primary completion date | May 31, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 5 Years to 17 Years |
Eligibility |
Inclusion Criteria of children: - autism spectrum disorders (ASD) diagnosis with symptoms of auditory hyper-sensitivity/reactivity. - verbal communication skills for utilizing the Subjective Units of Distress (SUD) scale (no cut-off for IQ). Exclusion Criteria of children - behavioral diagnosis of Oppositional Defiant Disorder or Conduct Disorder - history of child abuse that is related to sound sensitivity |
Country | Name | City | State |
---|---|---|---|
United States | UF Health Child and Adolescent Psychiatry/Medical Psychology | Gainesville | Florida |
United States | University of Florida | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Participant Subjective Unit of Distress (SUD) Level | The Subjective Unit of Distress (SUD) scale is a 0-10 scale used for the child and/or caregiver to report level of distress (i.e., pain, stress, anxiety, discomfort) before, during and/or after exposures to stimuli. We expect that SUDS levels will decrease over time indicating improved ability to tolerate auditory stimuli. | weekly for approximately 20 weeks from intake to exit | |
Secondary | Parent Stress Index | As an exploratory secondary outcome measure we will look for changes in scores on the parent Stress Index, a 36 item (5 point Likert scale response) parent report that is useful for identifying potential issues regarding the child's or parent's behavior and level of stress. It is also useful for designing treatment plans, setting goals, follow-up and evaluating pre-/post- treatment outcomes. | intake, end of baseline, end of treatment and exit (up to 4 times over approximately 20 weeks from intake to exit) | |
Secondary | Spence Child Anxiety Scale | As an exploratory secondary outcome measure we will look for changes in scores on the Spence Children's Anxiety Scale (SCAS). The SCAS child-report is a 45 item questionnaire and the SCAS Parent-Report is a 39 item questionnaires with 4-point Likert scale responses. Both forms assess six domains of anxiety including generalized anxiety, panic/agoraphobia, social phobia, separation anxiety, obsessive compulsive disorder and physical injury fears. | intake, end of baseline, end of treatment and exit (up to 4 times over approximately 20 weeks from intake to exit) | |
Secondary | Modified Khalfa Hyperacusis Questionnaire | As an exploratory secondary outcome measure we will look for changes in scores on the Modified Khalfa Hyperacusis Questionnaire, a brief 20 item (3-point Likert scale) questionnaire to screen for auditory hypersensitivity (hyper-acusis). | intake, end of baseline, end of treatment and exit (up to 4 times over approximately 20 weeks from intake to exit) | |
Secondary | Autism Symptoms | As an exploratory secondary outcome measure we will look for changes in scores on the Autism Diagnostic Observation Schedule - 2 (ADOS-2) and the Autism Spectrum Rating Scales (ASRS). The ADOS-2 is a play-based assessment that provides direct observation of the child's behavior and the ASRS is a norm-referenced, 71 item Likert scale parent questionnaire that identifies symptoms and behaviors across the autism spectrum. | intake (week 1) and exit (final session approximately 20 weeks after intake) | |
Secondary | Sensory Profile | As an exploratory secondary outcome measure we will look for changes in scores on the Sensory Profile-2. The Sensory Profile is an 86 item (5-point Likert scale) parent questionnaire (age 3-14) or Adolescent/adult questionnaire (ages 15 and above) that is used to evaluate how sensory processing and behaviors in a child compare to peers; norm-referenced on the following sensory sections: auditory, visual, touch, movement, body position, oral; behavioral sections: conduct, social/emotional and attention; as well as the following quadrants: seeking, avoiding, sensitivity and registration. | intake, end of baseline, end of treatment and exit (up to 4 times over approximately 20 weeks from intake to exit) |
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