Clinical trial NCT03206996: Exposure Therapy for Auditory Sensitivity in Autism
Official title: Treatment for Auditory Hyper-Reactivity Behavior in Children With Autism Using Exposure and Response Prevention Principles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sensory Disorders
Autism
Autism Spectrum Disorder
Autism With High Cognitive Abilities
Autistic Behavior
Hyperacusis
Keywords: autism
sensory over-responsiveness
auditory hyper-sensitivity
auditory processing
exposure therapy
exposure and response prevention
cognitive behavior therapy
occupational therapy
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 5
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-subjects design (baseline, treatment and follow-up)
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Sensory processing difficulties have been well documented in children with Autism Spectrum Disorder (ASD). In fact, "hyper- or hypo-reactivity to sensory input" has recently been added to the diagnostic criteria of this disorder. Hyper-reactivity features are particularly disruptive to children's abilities to engage in everyday activities and pose a significant problem for patients and their families. In children with high functioning pervasive developmental disorder, hyper-sensitivity is associated with symptoms of anxiety and depression. For sensory processing difficulties, children with ASD are primarily referred to Occupational Therapy (OT) services for treatment. These patients are also often seen by mental health professionals to address related disorders such as anxiety, ADHD and behavior problems. Currently, there are no evidence based approaches for specifically addressing auditory hyper-reactivity in ASD. Exposure and response prevention (E/RP), derived from systematic desensitization, is highly effective at reducing avoidance behaviors associated with phobias and obsessive and compulsive disorder (OCD). In mental healthcare settings, ER/P has been shown to be effective for reducing compulsive behaviors in children with OCD and concurrent ASD. E/RP has also been piloted for treating restricted, repetitive behaviors in ASD and demonstrates good feasibility. E/RP may also be useful for reducing aversive responses to auditory stimuli in children with ASD. Occupational Therapists (OT) are the primary service for providing treatment for sensory processing and arousal level modulation difficulties in children with ASD. Thus, OTs are potentially well suited to provide an E/RP aimed at reducing sensory hyper-reactivity in ASD. This study will investigate the feasibility and efficacy of utilizing an E/RP approach for treating auditory hyper-reactivity in ASD.

Eligibility criteria: 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

Primary outcomes:
measure: Participant Subjective Unit of Distress (SUD) Level
timeFrame: weekly for approximately 20 weeks from intake to exit
Secondary outcomes:
measure: Parent Stress Index
timeFrame: intake, end of baseline, end of treatment and exit (up to 4 times over approximately 20 weeks from intake to exit)
measure: Spence Child Anxiety Scale
timeFrame: intake, end of baseline, end of treatment and exit (up to 4 times over approximately 20 weeks from intake to exit)
measure: Modified Khalfa Hyperacusis Questionnaire
timeFrame: intake, end of baseline, end of treatment and exit (up to 4 times over approximately 20 weeks from intake to exit)
measure: Autism Symptoms
timeFrame: intake (week 1) and exit (final session approximately 20 weeks after intake)
measure: Sensory Profile
timeFrame: intake, end of baseline, end of treatment and exit (up to 4 times over approximately 20 weeks from intake to exit)
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health Child and Adolescent Psychiatry/Medical Psychology
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: Adjunct Associate Research Professor
name: Tana Carson, PhD
role: PRINCIPAL_INVESTIGATOR
References: