Autism Spectrum DisorderNCT03625999
A Novel Intervention for Training Auditory Attention in Adolescents With Autism Spectrum Disorder
A study testing video game training exercise in people with Autism Spectrum Disorder and Autism, run by Boston University Charles River Campus at 1 site in United States.
Trial summary
Background: Previous research has shown that individuals with ASD often have difficulties coping with auditory stimuli in the environment. These difficulties can be extremely debilitating, lead to anxiety and disruptive behaviors, and interfere with the ability to process and understand speech. Read more about this study
- Who is it for?
- Ages 13 to 20 years
- Conditions the study is for
- Autism Spectrum Disorder, Autism
- What is being tested?
- video game training exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2021to 30 Sep 2021
- 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 13 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescent children and young adults, both males and females;
- Between the ages of 13:0 and 20:11 years of age
- Speak or hear English at home at least 50% of the time
- Meet criteria for a confirmed diagnosis of Autism Spectrum Disorder.
Who cannot join
- Nonverbal mental age below 18 months
- Insufficient manual dexterity that would prevent working with a tablet or phone-based app
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Autism Research Excellence
Boston, Massachusetts, 02215
About this study
Background: Previous research has shown that individuals with ASD often have difficulties coping with auditory stimuli in the environment. These difficulties can be extremely debilitating, lead to anxiety and disruptive behaviors, and interfere with the ability to process and understand speech.
Research Design: In previous research, the investigators have identified a brain marker associated with poor auditory attention that can provide a direct readout of auditory processing issues. The investigators will develop and test a cognitive/behavioral intervention (a tablet-based game app) that is highly engaging and accessible to a wide range of individuals with ASD. The intervention is designed to train adolescents with ASD to adapt and attend to auditory cues.
Read more
Objectives: To evaluate whether the intervention leads to improvement in auditory attention as assessed by behavior changes over the course of training; to investigate the impact of the intervention on behavioral assessment of problems hearing speech in noisy environments, neural processing of sounds, and changes in parent report on responses to sounds that impact that daily lives of the participants; and finally- to determine which adolescents with ASD benefit the most and least from interventions such as this one.
We hypothesize that we can elicit changes in the neural processing of sounds for adolescents with ASD via training in the form of the tablet-based game we are developing. If we are successful, this could lead to other interventions for persons with ASD in the hopes of improving the auditory difficulties they face.
- Conditions
- Autism Spectrum Disorder, Autism
- Being tested
- video game training exercise
- Keywords
- Auditory attention
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video game training exerciseBehavioural
Also called game
The game, called "The Silent Service" and developed by our collaborators, is an online game with an underwater theme, and is comprised of 5 distinct mini-games, each of which demands auditory attention. The mission is to navigate an underwater scene, listening and responding to 'sonar' (e.g., an oddball in a stream of sounds). For example, participants may have to respond to an oddball sound stream to protect their submarine from a looming sea monster, while successfully ignoring a distractor sound stream (responses to the distractor sound stream allow the sea monster to damage the submarine). The five games share the same underlying framework of detecting oddballs while ignoring distractors but have unique artwork and 'backstories' to keep players interested. There is a hierarchical reward structure for 'leveling up' across the game that helps players to stay engaged and interested while playing.
| Study group | Role | What they receive |
|---|---|---|
| Training Group | Experimental | Parents and children selected for the Training group will be lent a laptop for the duration of the at-home training, and assisted in opening the video game training exercise. Parents and children will be shown the game's operation and controls, including a home visit to the family's house to help them establish the game as part of routine. Parents will be asked to engage their children in the video game training exercise (on the laptop) for a minimum of 20 minutes, 3 times a week, for 4 weeks. The app will log all responses as well as time spent playing. Receives: Behavioral: video game training exercise |
| Wait-List Control | No intervention | The families assigned to the wait-list control group will not receive access to the game until after 4 weeks and completion of the secondary round of testing at the lab. After the second lab visit and completion of the testing, families will be given access to the video game training exercise (on a loaned laptop), walked through the game's operation and controls, and encouraged to use it as often as they or their child like. If the child plays the game for a minimum of 20 minutes, 3 times per week, for 4 weeks, the family will be invited back to CARE for post-testing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Behavioral Assessment: ADOS
All participants will come back to the center after 4 weeks to complete post-test behavioral assessments, including ADOS (Autism Diagnostic Observation Scale). The ADOS measures autism signs and symptoms. The minimum and maximums range depending on the specific module used (ADOS is available in many modules, the appropriate module to use is selected by the expressive language ability of the participant), but in general, higher scores on the ADOS indicate more severe or widespread symptoms.
Measured: 4-6 weeks
Child Behavioral Assessment: Leiter-3
All participants will come back to the center after 4 weeks to complete post-test behavioral assessments, including Leiter-3. The Leiter-3 is a nonverbal intelligence assessment, and measures attention, activity level, mood regulation, organizational skills, anxiety, sociability, impulse control, energy \& feelings, and sensory reactivity. The range of composite scores is 30-170, and higher numbers indicate higher intelligence scores. The ranges encompass 'severe delay' to 'extremely high/gifted' so it can be used with persons of any ability.
Measured: 4-6 weeks
Child Behavioral Assessment: PPVT-5
All participants will come back to the center after 4 weeks to complete post-test behavioral assessments, including PPVT-4. The PPVT-4 (Peabody Picture Vocabulary Test) is a booklet containing pictures of commonly known items or objects, used to test receptive vocabulary, for example with verbal prompts such as "Which one is window?", or "Show me phone." The item is scored in terms of % correct responses, with a higher % correct indicating a bigger receptive vocabulary.
Measured: 4-6 weeks
Child Behavioral Assessment: EVT-3
All participants will come back to the center after 4 weeks to complete post-test behavioral assessments, including EVT-2. EVT-2 is a measure of expressive vocabulary and word retrieval. It can be used to quickly assess expressive vocabulary without requiring reading or writing. Standard scores range from 20 to 160, encompassing 'extremely low' to 'extremely high' so it can be used with persons of any english language ability. Higher scores indicate higher expressive language ability.
Measured: 4-6 weeks
Parent Questionnaire: SCQ
All participants will come back to the center after 4 weeks to have parents or caregivers complete post-test behavioral questionnaires, including the SCQ (Social Communication Questionnaire). The SCQ was designed to evaluate communication skills and social functioning in children who may have ASD, and consists of yes-or-no questions so that it can be completed quickly. Higher scores indicate more severe or widespread symptoms.
Measured: 4-6 weeks
Parent Questionnaire: VABS-3
All participants will come back to the center after 4 weeks to have parents or caregivers complete post-test behavioral questionnaires, including the VABS-3 (Vineland Adaptive Behavior Scales). The Vineland provides scores for adaptive behavior domains (Communication, Daily Living Skills, Socialization, Motor Skills and Maladaptive Skills), and is designed to assess ability for self-sufficiency based on its ability to measure personal skills needed for everyday life. For each subdomain, scores range from 1 to 24, and for total scores, the range is 20 to 140. In both cases, higher scores indicate a positive ability to use or employ an adaptive behavior in place of a personal weakness or difficulty, so a better ability to work around one's limitations.
Measured: 4-6 weeks
Parent Questionnaire: RBS-R
All participants will come back to the center after 4 weeks to have parents or caregivers complete post-test behavioral questionnaires, including the RBS-R (Repetitive Behavior Scales, revised). The RBS-R provides a quantitative, continuous measure of the full spectrum of repetitive behaviors, consisting of six subscales (Stereotyped behavior, Self-Injurious behavior, Compulsive behavior, Routine behavior, Sameness behavior, and Restricted behavior). Each behavior listed within each subscale is scored on a scale of 0 to 3, where 0 means a behavior does not occur and 3 means a behavior is a severe problem. As such, for the total score, a higher score means more extreme repetitive behaviors.
Measured: 4-6 weeks
Parent Questionnaire: SSP
All participants will come back to the center after 4 weeks to have parents or caregivers complete post-test behavioral questionnaires, including the SSP (Short Sensory Profile). The sensory profile is a measure of responses to sensory events in daily life. There are several sections, encompassing a range of sensory experiences (tactile, taste/smell, movement, seeks sensation, auditory filtering, low energy/weak, and visual/auditory sensitivity), and the total score ranges between 38 and 190, with 38 and other low numbers reflecting an extreme difference from typically developing peers, and 190 and other high numbers reflecting a similarity to typically developing peers.
Measured: 4-6 weeks
Parent Questionnaire: CASI-5
All participants will come back to the center after 4 weeks to have parents or caregivers complete post-test behavioral questionnaires, including the CASI-5 (Child and Adolescent Symptom Inventory). The CASI-5 is a behavior rating scale that assesses symptoms of a range of 15 different developmental, emotional, and behavioral disorders that can be used to assess any comorbidities a subject may display symptoms for. The scores (total range 0-100) are calculated depending on several factors, but in general, higher numbers indicate the presence of more symptoms (of any disorder) and lower numbers indicate fewer symptoms or less impairment.
Measured: 4-6 weeks
Post-test EEG
All participants will come back to the center after 4 weeks to complete post-test EEG testing. Participants will wear an EEG net connected with elastic threads while listening to sound series designed to assess attention to distinctive sounds. During the task, investigators will assess waveforms alpha, beta, theta, gamma and delta to look for differences in auditory processing between first visit and post-test visit.
Measured: 4-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start1 Aug 2021 (estimated)
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Why it stopped: Our study stopped before it could begin because of the Covid-19 pandemic. We revised the study so that it could be performed virtually, but the revised study isn't a clinical trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Collaborators
- Carnegie Mellon University
- Responsible party
- Principal investigator, Helen B. Tager-Flusberg, Boston University Charles River Campus
- Investigators
- Helen Tager-Flusberg, PhD, Study chair, Prinicipal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03625999
- Sponsor's protocol ID
- 4875E
- Status last verified
- Apr 2021
- First submitted
- 6 Aug 2018
- Last updated
- 9 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Intervention for Training Auditory Attention in Adolescents With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT03625999
- Acronym / sponsor ID
- 4875E
- Conditions
- Autism Spectrum Disorder, Autism
- Keywords
- Auditory attention
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Our study stopped before it could begin because of the Covid-19 pandemic. We revised the study so that it could be performed virtually, but the revised study isn't a clinical trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- Carnegie Mellon University
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 10 Aug 2018 (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.
Background: Previous research has shown that individuals with ASD often have difficulties coping with auditory stimuli in the environment. These difficulties can be extremely debilitating, lead to anxiety and disruptive behaviors, and interfere with the ability to process and understand speech.
Research Design: In previous research, the investigators have identified a brain marker associated with poor auditory attention that can provide a direct readout of auditory processing issues. The investigators will develop and test a cognitive/behavioral intervention (a tablet-based game app) that is highly engaging and accessible to a wide range of individuals with ASD. The intervention is designed to train adolescents with ASD to adapt and attend to auditory cues.
Objectives: To evaluate whether the intervention leads to improvement in auditory attention as assessed by behavior changes over the course of training; to investigate the impact of the intervention on behavioral assessment of problems hearing speech in noisy environments, neural processing of sounds, and changes in parent report on responses to sounds that impact that daily lives of the participants; and finally- to determine which adolescents with ASD benefit the most and least from interventions such as this one.
We hypothesize that we can elicit changes in the neural processing of sounds for adolescents with ASD via training in the form of the tablet-based game we are developing. If we are successful, this could lead to other interventions for persons with ASD in the hopes of improving the auditory difficulties they face.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training Group | Experimental | Behavioral: video game training exerciseParents and children selected for the Training group will be lent a laptop for the duration of the at-home training, and assisted in opening the video game training exercise. Parents and children will be shown the game's operation and controls, including a home visit to the family's house to help them establish the game as part of routine. Parents will be asked to engage their children in the video game training exercise (on the laptop) for a minimum of 20 minutes, 3 times a week, for 4 weeks. The app will log all responses as well as time spent playing. |
| Wait-List Control | No intervention | –The families assigned to the wait-list control group will not receive access to the game until after 4 weeks and completion of the secondary round of testing at the lab. After the second lab visit and completion of the testing, families will be given access to the video game training exercise (on a loaned laptop), walked through the game's operation and controls, and encouraged to use it as often as they or their child like. If the child plays the game for a minimum of 20 minutes, 3 times per week, for 4 weeks, the family will be invited back to CARE for post-testing. |
Who may qualify
- Ages
- 13 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Adolescent children and young adults, both males and females;
- Between the ages of 13:0 and 20:11 years of age
- Speak or hear English at home at least 50% of the time
- Meet criteria for a confirmed diagnosis of Autism Spectrum Disorder.
Key exclusion criteria (2 listed)
- Nonverbal mental age below 18 months
- Insufficient manual dexterity that would prevent working with a tablet or phone-based app
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 |
|---|---|---|
| video game training exerciseAlso: gameThe game, called "The Silent Service" and developed by our collaborators, is an online game with an underwater theme, and is comprised of 5 distinct mini-games, each of which demands auditory attention. The mission is to navigate an underwater scene, listening and responding to 'sonar' (e.g., an oddball in a stream of sounds). For example, participants may have to respond to an oddball sound stream to protect their submarine from a looming sea monster, while successfully ignoring a distractor sound stream (responses to the distractor sound stream allow the sea monster to damage the submarine). The five games share the same underlying framework of detecting oddballs while ignoring distractors but have unique artwork and 'backstories' to keep players interested. There is a hierarchical reward structure for 'leveling up' across the game that helps players to stay engaged and interested while playing. | Behavioural | Training Group |
Primary outcome
Child Behavioral Assessment: ADOS
Time frame: 4-6 weeks
All participants will come back to the center after 4 weeks to complete post-test behavioral assessments, including ADOS (Autism Diagnostic Observation Scale). The ADOS measures autism signs and symptoms. The minimum and maximums range depending on the specific module used (ADOS is available in many modules, the appropriate module to use is selected by the expressive language ability of the participant), but in general, higher scores on the ADOS indicate more severe or widespread symptoms.
Child Behavioral Assessment: Leiter-3
Time frame: 4-6 weeks
All participants will come back to the center after 4 weeks to complete post-test behavioral assessments, including Leiter-3. The Leiter-3 is a nonverbal intelligence assessment, and measures attention, activity level, mood regulation, organizational skills, anxiety, sociability, impulse control, energy \& feelings, and sensory reactivity. The range of composite scores is 30-170, and higher numbers indicate higher intelligence scores. The ranges encompass 'severe delay' to 'extremely high/gifted' so it can be used with persons of any ability.
Child Behavioral Assessment: PPVT-5
Time frame: 4-6 weeks
All participants will come back to the center after 4 weeks to complete post-test behavioral assessments, including PPVT-4. The PPVT-4 (Peabody Picture Vocabulary Test) is a booklet containing pictures of commonly known items or objects, used to test receptive vocabulary, for example with verbal prompts such as "Which one is window?", or "Show me phone." The item is scored in terms of % correct responses, with a higher % correct indicating a bigger receptive vocabulary.
Child Behavioral Assessment: EVT-3
Time frame: 4-6 weeks
All participants will come back to the center after 4 weeks to complete post-test behavioral assessments, including EVT-2. EVT-2 is a measure of expressive vocabulary and word retrieval. It can be used to quickly assess expressive vocabulary without requiring reading or writing. Standard scores range from 20 to 160, encompassing 'extremely low' to 'extremely high' so it can be used with persons of any english language ability. Higher scores indicate higher expressive language ability.
Parent Questionnaire: SCQ
Time frame: 4-6 weeks
All participants will come back to the center after 4 weeks to have parents or caregivers complete post-test behavioral questionnaires, including the SCQ (Social Communication Questionnaire). The SCQ was designed to evaluate communication skills and social functioning in children who may have ASD, and consists of yes-or-no questions so that it can be completed quickly. Higher scores indicate more severe or widespread symptoms.
Parent Questionnaire: VABS-3
Time frame: 4-6 weeks
All participants will come back to the center after 4 weeks to have parents or caregivers complete post-test behavioral questionnaires, including the VABS-3 (Vineland Adaptive Behavior Scales). The Vineland provides scores for adaptive behavior domains (Communication, Daily Living Skills, Socialization, Motor Skills and Maladaptive Skills), and is designed to assess ability for self-sufficiency based on its ability to measure personal skills needed for everyday life. For each subdomain, scores range from 1 to 24, and for total scores, the range is 20 to 140. In both cases, higher scores indicate a positive ability to use or employ an adaptive behavior in place of a personal weakness or difficulty, so a better ability to work around one's limitations.
Parent Questionnaire: RBS-R
Time frame: 4-6 weeks
All participants will come back to the center after 4 weeks to have parents or caregivers complete post-test behavioral questionnaires, including the RBS-R (Repetitive Behavior Scales, revised). The RBS-R provides a quantitative, continuous measure of the full spectrum of repetitive behaviors, consisting of six subscales (Stereotyped behavior, Self-Injurious behavior, Compulsive behavior, Routine behavior, Sameness behavior, and Restricted behavior). Each behavior listed within each subscale is scored on a scale of 0 to 3, where 0 means a behavior does not occur and 3 means a behavior is a severe problem. As such, for the total score, a higher score means more extreme repetitive behaviors.
Parent Questionnaire: SSP
Time frame: 4-6 weeks
All participants will come back to the center after 4 weeks to have parents or caregivers complete post-test behavioral questionnaires, including the SSP (Short Sensory Profile). The sensory profile is a measure of responses to sensory events in daily life. There are several sections, encompassing a range of sensory experiences (tactile, taste/smell, movement, seeks sensation, auditory filtering, low energy/weak, and visual/auditory sensitivity), and the total score ranges between 38 and 190, with 38 and other low numbers reflecting an extreme difference from typically developing peers, and 190 and other high numbers reflecting a similarity to typically developing peers.
Parent Questionnaire: CASI-5
Time frame: 4-6 weeks
All participants will come back to the center after 4 weeks to have parents or caregivers complete post-test behavioral questionnaires, including the CASI-5 (Child and Adolescent Symptom Inventory). The CASI-5 is a behavior rating scale that assesses symptoms of a range of 15 different developmental, emotional, and behavioral disorders that can be used to assess any comorbidities a subject may display symptoms for. The scores (total range 0-100) are calculated depending on several factors, but in general, higher numbers indicate the presence of more symptoms (of any disorder) and lower numbers indicate fewer symptoms or less impairment.
Post-test EEG
Time frame: 4-6 weeks
All participants will come back to the center after 4 weeks to complete post-test EEG testing. Participants will wear an EEG net connected with elastic threads while listening to sound series designed to assess attention to distinctive sounds. During the task, investigators will assess waveforms alpha, beta, theta, gamma and delta to look for differences in auditory processing between first visit and post-test visit.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2021.
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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.
Helen Tager-Flusberg, PhD study chair
Prinicipal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing video game training exercise in people with Autism Spectrum Disorder and Autism, run by Boston University Charles River Campus at 1 site 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 4 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: withdrawn, as of the sponsor's last update on 9 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.
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?
Child Behavioral Assessment: ADOS (time frame: 4-6 weeks). The study lists 10 primary outcomes in all. 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 9 Apr 2021.