search
Back to results

Exposure Therapy for Auditory Sensitivity in Autism

Primary Purpose

Sensory Disorders, Autism, Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exposure therapy
Psycho-education
Caregiver education/home program development
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sensory Disorders focused on measuring autism, sensory over-responsiveness, auditory hyper-sensitivity, auditory processing, exposure therapy, exposure and response prevention, cognitive behavior therapy, occupational therapy

Eligibility Criteria

5 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UF Health Child and Adolescent Psychiatry/Medical Psychology
  • University of Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Child Interventional

Parental Interventional

Arm Description

A 12 week patient-centered modified E/RP protocol for up to 5 participants with ASD and auditory hyper-reactivity. E/RP protocols will include face-to-face treatment sessions as well as the provision of home programs. Treatment fidelity checklists will be utilized each session to ensure that each participant receive the same general protocol/treatment process

A 12 week patient-centered modified E/RP protocol for up to 5 participants with ASD and auditory hyper-reactivity. E/RP protocols will include face-to-face treatment sessions as well as the provision of home programs. Treatment fidelity checklists will be utilized each session to ensure that each participant receive the same general protocol/treatment process

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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).
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.
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.

Full Information

First Posted
June 26, 2017
Last Updated
June 14, 2019
Sponsor
University of Florida
search

1. Study Identification

Unique Protocol Identification Number
NCT03206996
Brief Title
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

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
September 30, 2017 (Actual)
Primary Completion Date
May 31, 2019 (Actual)
Study Completion Date
May 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single-subjects design (baseline, treatment and follow-up)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Child Interventional
Arm Type
Experimental
Arm Description
A 12 week patient-centered modified E/RP protocol for up to 5 participants with ASD and auditory hyper-reactivity. E/RP protocols will include face-to-face treatment sessions as well as the provision of home programs. Treatment fidelity checklists will be utilized each session to ensure that each participant receive the same general protocol/treatment process
Arm Title
Parental Interventional
Arm Type
Experimental
Arm Description
A 12 week patient-centered modified E/RP protocol for up to 5 participants with ASD and auditory hyper-reactivity. E/RP protocols will include face-to-face treatment sessions as well as the provision of home programs. Treatment fidelity checklists will be utilized each session to ensure that each participant receive the same general protocol/treatment process
Intervention Type
Behavioral
Intervention Name(s)
Exposure therapy
Other Intervention Name(s)
cognitive behavioral therapy, exposure and response prevention, systematic desensitization
Intervention Description
The therapist, child and family collaborate to set short and long term goals, develop the exposure hierarchy and Subjective Units of Distress (SUD) scale and design their "challenge" activities (i.e., exposures). The exposure hierarchy lists activities in ascending order from minimal exposure/minimally difficult (e.g, toilet is not flushed and bathroom door is closed while child walks by) to maximum exposure/maximally difficult (e.g., toilet is flushed repeatedly while child is inside the stall with the door closed). Treatment begins with exposure to activities on the lower end of the hierarchy, with adjustments as indicated, to present stimuli that provide a "just-right" level of difficulty as indicated by the participant's SUD level and therapists clinical judgment. Participants communicate the level of difficulty using their individualized SUD scale. Additionally, the child and family complete home exercises with exposures.
Intervention Type
Behavioral
Intervention Name(s)
Psycho-education
Intervention Description
Child and caregiver receive education and training will be provided to improve the participant's self-awareness of his/her behavioral and emotional response to auditory stimuli, his/her ability to self-report anxiety/emotional response levels, as well as his/her ability to identify useful arousal level modulation/coping strategies. During this phase, the child, caregiver and therapist will collaborate to identify the participant's Subjective Units of Distress Scale (SUD) from 0-10 with each level defined, particularly for what levels are tolerable or intolerable.
Intervention Type
Behavioral
Intervention Name(s)
Caregiver education/home program development
Intervention Description
Parents will be provided with education on home programs to facilitate treatment gains. Home programs will be designed specifically for each participant. Parent education and home programs are provided either concurrently or after the exposure phase for the family to apply these methods to other settings. Home programs can continue as a maintenance program after treatment has ended. At the end of the treatment phase, the study team will conduct the following assessments for a third time: (1) the Sensory Profile, a clinical tool commonly used in OT to assess parent reports of sensory processing difficulties in children, (2) Parent Stress Index - 4 to evaluate stress related to parent-child interactions, and (3) the Modified Khalfa Hyper-acusis Questionnaire to assess the level of hyper-sensitivity to sound.
Primary Outcome Measure Information:
Title
Participant Subjective Unit of Distress (SUD) Level
Description
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.
Time Frame
weekly for approximately 20 weeks from intake to exit
Secondary Outcome Measure Information:
Title
Parent Stress Index
Description
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.
Time Frame
intake, end of baseline, end of treatment and exit (up to 4 times over approximately 20 weeks from intake to exit)
Title
Spence Child Anxiety Scale
Description
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.
Time Frame
intake, end of baseline, end of treatment and exit (up to 4 times over approximately 20 weeks from intake to exit)
Title
Modified Khalfa Hyperacusis Questionnaire
Description
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).
Time Frame
intake, end of baseline, end of treatment and exit (up to 4 times over approximately 20 weeks from intake to exit)
Title
Autism Symptoms
Description
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.
Time Frame
intake (week 1) and exit (final session approximately 20 weeks after intake)
Title
Sensory Profile
Description
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.
Time Frame
intake, end of baseline, end of treatment and exit (up to 4 times over approximately 20 weeks from intake to exit)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tana Carson, PhD
Organizational Affiliation
Adjunct Associate Research Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
UF Health Child and Adolescent Psychiatry/Medical Psychology
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32606
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Exposure Therapy for Auditory Sensitivity in Autism

We'll reach out to this number within 24 hrs