Exposure Therapy for Auditory Sensitivity in Autism

NCT03206996 | Completed

• 1 other identifier: IRB201601664
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Parent Stress Index

  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

  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

  intake, end of baseline, end of treatment and exit (up to 4 times over approximately 20 weeks from intake to exit)

• Autism Symptoms

  intake (week 1) and exit (final session approximately 20 weeks after intake)

• Sensory Profile

  intake, end of baseline, end of treatment and exit (up to 4 times over approximately 20 weeks from intake to exit)

Study Arms (2)

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

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

Behavioral: Caregiver education/home program development

Interventions

Exposure therapy BEHAVIORAL

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.

Also known as: cognitive behavioral therapy, exposure and response prevention, systematic desensitization

Child Interventional

Psycho-education BEHAVIORAL

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.

Child Interventional

Caregiver education/home program development BEHAVIORAL

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.

Child Interventional; Parental Interventional

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• behavioral diagnosis of Oppositional Defiant Disorder or Conduct Disorder
• history of child abuse that is related to sound sensitivity

Sponsors & Collaborators

• University of Florida: lead

Study Sites (2)

UF Health Child and Adolescent Psychiatry/Medical Psychology

Gainesville, Florida, 32606, United States

Location

University of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Sensation Disorders; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Hyperacusis

Interventions

Implosive Therapy; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Tana Carson, PhD

  Adjunct Associate Research Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-subjects design (baseline, treatment and follow-up)

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: July 2, 2017
• Study Start: September 30, 2017
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: June 18, 2019

Record last verified: 2019-06

Locations

US (2)