Sensory DisordersNCT03206996
Exposure Therapy for Auditory Sensitivity in Autism
A study testing Exposure therapy, Psycho-education and Caregiver education/home program development in people with Sensory Disorders and Autism, run by University of Florida at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Sensory Disorders, Autism, Autism Spectrum Disorder
- What is being tested?
- Exposure therapy, Psycho-education and Caregiver education/home program development
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Sep 2017to 31 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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).
Who cannot join
- behavioral diagnosis of Oppositional Defiant Disorder or Conduct Disorder
- history of child abuse that is related to sound sensitivity
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UF Health Child and Adolescent Psychiatry/Medical Psychology
Gainesville, Florida, 32606
University of Florida
Gainesville, Florida, 32611
About this study
Official title: Treatment for Auditory Hyper-Reactivity Behavior in Children With Autism Using Exposure and Response Prevention Principles
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.
Read the 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.
- Conditions
- Sensory Disorders, Autism, Autism Spectrum Disorder, Autism With High Cognitive Abilities, Autistic Behavior, Hyperacusis
- Being tested
- Exposure therapy, Psycho-education, Caregiver education/home program development
- Keywords
- autism, sensory over-responsiveness, auditory hyper-sensitivity, auditory processing, exposure therapy, exposure and response prevention, cognitive behavior therapy, occupational therapy
- Medical subject headings
- Sensation Disorders, Autistic Disorder, Autism Spectrum Disorder, Child Development Disorders, Pervasive, Hyperacusis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure therapyBehavioural
Also called cognitive behavioral therapy, exposure and response prevention, systematic desensitization
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.
Psycho-educationBehavioural
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.
Caregiver education/home program developmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Child Interventional | Experimental | 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 Receives: Behavioral: Exposure therapy; Behavioral: Psycho-education; Behavioral: Caregiver education/home program development |
| Parental Interventional | Experimental | 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 Receives: Behavioral: Caregiver education/home program development |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: weekly for approximately 20 weeks from intake to exit
Secondary outcomes (5)
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.
Measured: intake, end of baseline, end of treatment and exit (up to 4 times over approximately 20 weeks from intake to exit)
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.
Measured: intake, end of baseline, end of treatment and exit (up to 4 times over approximately 20 weeks from intake to exit)
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).
Measured: intake, end of baseline, end of treatment and exit (up to 4 times over approximately 20 weeks from intake to exit)
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.
Measured: intake (week 1) and exit (final session approximately 20 weeks after intake)
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.
Measured: intake, end of baseline, end of treatment and exit (up to 4 times over approximately 20 weeks from intake to exit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start30 Sep 2017
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensory DisordersStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Single-subjects design (baseline, treatment and follow-up)
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tana Carson, PhD, Principal investigator, Adjunct Associate Research Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03206996
- Sponsor's protocol ID
- IRB201601664
- Status last verified
- Jun 2019
- First submitted
- 26 Jun 2017
- Last updated
- 18 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment for Auditory Hyper-Reactivity Behavior in Children With Autism Using Exposure and Response Prevention Principles
- ClinicalTrials.gov ID
- NCT03206996
- Acronym / sponsor ID
- IRB201601664
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 30 Sep 2017 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single-subjects design (baseline, treatment and follow-up)
| Arm | Type | Receives |
|---|---|---|
| Child Interventional | Experimental | Behavioral: Exposure therapy, Behavioral: Psycho-education, Behavioral: Caregiver education/home program developmentA 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 |
| Parental Interventional | Experimental | Behavioral: Caregiver education/home program developmentA 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 |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (2 listed)
- behavioral diagnosis of Oppositional Defiant Disorder or Conduct Disorder
- history of child abuse that is related to sound sensitivity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure therapyAlso: cognitive behavioral therapy, exposure and response prevention, systematic desensitizationThe 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. | Behavioural | Child Interventional |
| Psycho-educationChild 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. | Behavioural | Child Interventional |
| Caregiver education/home program developmentParents 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. | Behavioural | Child Interventional, Parental Interventional |
Primary outcome
Participant Subjective Unit of Distress (SUD) Level
Time frame: weekly for approximately 20 weeks from intake to exit
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.
5 secondary outcomes
Parent Stress Index
Time frame: intake, end of baseline, end of treatment and exit (up to 4 times over approximately 20 weeks from intake to exit)
Spence Child Anxiety Scale
Time frame: intake, end of baseline, end of treatment and exit (up to 4 times over approximately 20 weeks from intake to exit)
Modified Khalfa Hyperacusis Questionnaire
Time frame: intake, end of baseline, end of treatment and exit (up to 4 times over approximately 20 weeks from intake to exit)
Autism Symptoms
Time frame: intake (week 1) and exit (final session approximately 20 weeks after intake)
Sensory Profile
Time frame: intake, end of baseline, end of treatment and exit (up to 4 times over approximately 20 weeks from intake to exit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tana Carson, PhD principal investigator
Adjunct Associate Research Professor
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure therapy, Psycho-education and Caregiver education/home program development in people with Sensory Disorders and Autism, run by University of Florida at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Subjective Unit of Distress (SUD) Level (time frame: weekly for approximately 20 weeks from intake to exit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2019; AzTrials last refreshed its copy on 27 Oct 2026.