Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03206996
Other study ID # IRB201601664
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 30, 2017
Est. completion date May 31, 2019

Study information

Verified date June 2019
Source University of Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. This study is the first to assess the feasibility and efficacy of E/RP for auditory sensory hyper-reactivity in ASD.


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.


Recruitment information / eligibility

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

Study Design


Intervention

Behavioral:
Exposure therapy
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-education
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 development
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.

Locations

Country Name City State
United States UF Health Child and Adolescent Psychiatry/Medical Psychology Gainesville Florida
United States University of Florida Gainesville Florida

Sponsors (1)

Lead Sponsor Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

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)
See also
  Status Clinical Trial Phase
Completed NCT05207956 - App for Strengthening Services In Specialized Therapeutic Support N/A
Completed NCT03286621 - Development of Eye-tracking Based Markers for Autism in Young Children
Completed NCT02608333 - Efficiency of Early Intervention for Autism Spectrum Disorder N/A
Recruiting NCT05935722 - Evaluation of a Home-based Parenting Support Program: Parenting Young Children N/A
Active, not recruiting NCT06259539 - A YouTube Curriculum for Children With Autism and Obesity N/A
Active, not recruiting NCT06303791 - Digital-based Psychosocial Intervention for Parents of Children With Neurodevelopmental Disorders N/A
Enrolling by invitation NCT05017779 - A Hybrid Effectiveness-implementation Trial of a High School-based Executive Function Treatment for Autistic Youth N/A
Completed NCT04772898 - Effectiveness of a 6-week Hippotherapy Program in Children With Autism Spectrum Disorder N/A
Recruiting NCT04987541 - The Therapeutic Effect of TBS Stimulation on Emotion Regulation in Autism Spectrum Disorder N/A
Completed NCT04308915 - Mobile-based Games for Cognitive Training in Children With Neurodevelopmental Disorders N/A
Completed NCT06038435 - The Effect of Cognitive Orientation Approach on Daily Occupational Performance With Autism Spectrum Disorder N/A
Terminated NCT04049981 - Investigation of Mechanisms of Action in Superpower Glass Phase 1/Phase 2
Completed NCT03693313 - The Effect of CrossFit Kids on Social Skills in Children With Autism Spectrum Disorder (CrossFit KAMP) N/A
Recruiting NCT04107064 - Achieving Steady Work Among Adults With Autism Through Specialized Employment Program N/A
Recruiting NCT03812068 - Parent-mediated Developmental Behavioral Intervention N/A
Completed NCT02299700 - Study to Evaluate the Janssen Autism Knowledge Engine in Children and Adults With Autism Spectrum Disorder N/A
Completed NCT03422016 - Electroretinogram in Autistic Spectrum Disorders
Active, not recruiting NCT03548779 - North Carolina Genomic Evaluation by Next-generation Exome Sequencing, 2 N/A
Recruiting NCT05114538 - Improving the Part C Early Intervention Service Delivery System for Children With ASD N/A
Completed NCT04147988 - Characterizing ASD Adult Population Asking for a Diagnosis N/A