Stuttering, AdultNCT06422442
Information Processing Biases in Adults Who Stutter
A study testing Threat-related stimulus exposure in people with Stuttering, Adult, run by University of Memphis at 1 site in United States.
Trial summary
The goal of this clinical trial is to examine whether stuttering is associated with a tendency to attend more quickly or for longer durations to threat-related information in the environment (threat-related attention bias). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stuttering, Adult
- What is being tested?
- Threat-related stimulus exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2023to 30 Jun 2026
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Speaks English as their primary language
- Normal hearing (based on pure tone screening)
- Normal or corrected vision (based on report)
- Normal color vision (based on Ishihara Test, Concise Edition)
- Nonverbal intelligence within at least average range based on Test of Nonverbal Intelligence, 4th Edition
- Expressive language within at least average range score based on Expressive One-Word Picture Vocabulary Test
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- Additional inclusion criteria for adults who stutter:
- Self-identification as a person who stutters
- Score of at least 11 (mild stuttering) on Stuttering Severity Index, 4th Edition
Who cannot join
- Reported significant medical history
- Psychological or emotional disorder
- History of frank neurological injury
- Known speech, language, or learning disorder(s) other than stuttering
- Reading difficulties
- Score within clinically significant range for ADHD on Adults ADHD Self-Rating Scale
- Score within clinically significant range for depression on Beck Depression Inventory
- Score within clinically significant range for anxiety on State-Trait Anxiety Inventory
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Memphis
Memphis, Tennessee, 38152
Naomi Eichorn, PhD, 901-678-5825, neichorn@memphis.edu
Edina Bene, (901) 678-2573, ebene@memphis.edu
About this study
Official title: Information Processing Biases in Adults Who Stutter: Behavioral and Eye-tracking Indices of Threat-related Attention Allocation
The goal of this clinical trial is to examine whether stuttering is associated with a tendency to attend more quickly or for longer durations to threat-related information in the environment (threat-related attention bias). The main questions it aims to answer are:
Do adults who stutter, relative to adults who do not stutter, attend to threat-related stimuli more than neutral information? Are attentional biases observed across different types of threat or are they specific to threats related to stuttering experiences? Do measures of attention bias explain individual differences in psychological reactions among adults who stutter?
Read the detailed description
The goal of the project is to examine threat-related attentional processes associated with stuttering. In Aim 1, investigators will establish differences in attention bias (AB) in adults who do and do not stutter and the processing stage at which differences emerge. In Aim 2, investigators will compare AB effects across different categories of threat stimuli to determine whether threat-related AB in adults who stutter is general or disorder-specific. In Aim 3, the investigators examine the role of AB as a causal factor mediating effects of individual risk-factors (related to temperament and attention control) on stuttering impact and anticipation. Participants will include 35 adults who stutter and 35 adults who stutter between the ages of 18-30 years, all meeting specified eligibility criteria. All participants will complete three experimental tasks for measuring AB: (1) a free-viewing task, (2) dot-probe task, and (3) emotional Stroop task. Study procedures will be administered over two sessions (2-2.5 hours each) scheduled within three weeks of each other. Key outcomes will include reaction time and eye-tracking measures, which will be used to extract multiple AB indices. Data will be analyzed via mixed-effects regression analysis with a random intercept for subject and maximal converging random-slopes structure. Age, gender, socioeconomic status and various measures used for inclusion purposes will be included as covariates. Mediation analyses will assess four relationships (Temperament -> Stuttering impact, Temperament -> Anticipation, Attention control -> Stuttering impact, and Attention control -> Anticipation), with AB as the mediator variable in each analysis.
- Conditions
- Stuttering, Adult
- Being tested
- Threat-related stimulus exposure
- Medical subject headings
- Stuttering
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Threat-related stimulus exposureBehavioural
Participants will view threat-related stimuli (words or faces) paired with nonthreat matches in three related experimental paradigms.
| Study group | Role | What they receive |
|---|---|---|
| Eye tracking tasks | Experimental | All participants complete three tasks in which they view threat-related and neutral stimuli (words or faces) Receives: Behavioral: Threat-related stimulus exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reaction time (RT) measures
- A key outcome measure from the dot-probe task will consist of RTs for congruent trials (in which probe appears in the location of threat stimulus) vs. incongruent trials (probe replaces neutral stimulus). (B) Key outcome measure from the emotional Stroop will include RT for threat vs. neutral words.
Measured: Trial duration (maximum of 10 seconds)
Total dwell time on threat
This primary (and most reliable) index of AB will be extracted from eye movement data and represents the total duration of all fixations to areas of interest with threat stimuli for each trial of the free-viewing task.
Measured: Trial duration (8 seconds)
Secondary outcomes (1)
Eye tracking indices of AB
Additional indices of AB will be extracted from eye movement data and examined in exploratory manner: (1) probability of first fixation to an area of of interest (AOI), (2) first fixation latency, (3) first fixation duration, 4) first-run dwell time (representing summed duration of all fixations to an AOI from the first fixation until the AOI is exited), and (5) second-run dwell time (summed duration of all fixations within an AOI from the second time the AOI is entered until it is exited).
Measured: Trial duration (8 seconds)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start11 Sep 2023
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stuttering, AdultStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Memphis
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama, Tuscaloosa
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06422442
- Sponsor's protocol ID
- R21DC020557
- Status last verified
- May 2024
- First submitted
- 13 May 2024
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be made freely and publicly available on OSF (https://osf.io) together with our publications, with prior Institutional Review Board approval. Archived data will also be made available to other researchers upon request (by emailing the PI) and without cost. A signed data-sharing agreement will be required for researchers to access data; the agreement will stipulate that shared data must be used solely for the purpose of research, must not be transferred to or shared with others, must not be manipulated for the purpose of identifying subjects, and that the planned research must be reviewed and approved by an Institutional Review Board.
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Information Processing Biases in Adults Who Stutter: Behavioral and Eye-tracking Indices of Threat-related Attention Allocation
- ClinicalTrials.gov ID
- NCT06422442
- Acronym / sponsor ID
- R21DC020557
- Conditions
- Stuttering, Adult
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of MemphisUniversity, hospital or other
- Collaborators
- University of Alabama, Tuscaloosa
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 21 May 2024 (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.
The goal of this clinical trial is to examine whether stuttering is associated with a tendency to attend more quickly or for longer durations to threat-related information in the environment (threat-related attention bias). The main questions it aims to answer are:
Do adults who stutter, relative to adults who do not stutter, attend to threat-related stimuli more than neutral information? Are attentional biases observed across different types of threat or are they specific to threats related to stuttering experiences? Do measures of attention bias explain individual differences in psychological reactions among adults who stutter?
Detailed description
The goal of the project is to examine threat-related attentional processes associated with stuttering. In Aim 1, investigators will establish differences in attention bias (AB) in adults who do and do not stutter and the processing stage at which differences emerge. In Aim 2, investigators will compare AB effects across different categories of threat stimuli to determine whether threat-related AB in adults who stutter is general or disorder-specific. In Aim 3, the investigators examine the role of AB as a causal factor mediating effects of individual risk-factors (related to temperament and attention control) on stuttering impact and anticipation. Participants will include 35 adults who stutter and 35 adults who stutter between the ages of 18-30 years, all meeting specified eligibility criteria. All participants will complete three experimental tasks for measuring AB: (1) a free-viewing task, (2) dot-probe task, and (3) emotional Stroop task. Study procedures will be administered over two sessions (2-2.5 hours each) scheduled within three weeks of each other. Key outcomes will include reaction time and eye-tracking measures, which will be used to extract multiple AB indices. Data will be analyzed via mixed-effects regression analysis with a random intercept for subject and maximal converging random-slopes structure. Age, gender, socioeconomic status and various measures used for inclusion purposes will be included as covariates. Mediation analyses will assess four relationships (Temperament -> Stuttering impact, Temperament -> Anticipation, Attention control -> Stuttering impact, and Attention control -> Anticipation), with AB as the mediator variable in each analysis.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eye tracking tasks | Experimental | Behavioral: Threat-related stimulus exposureAll participants complete three tasks in which they view threat-related and neutral stimuli (words or faces) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Speaks English as their primary language
- Normal hearing (based on pure tone screening)
- Normal or corrected vision (based on report)
- Normal color vision (based on Ishihara Test, Concise Edition)
- Nonverbal intelligence within at least average range based on Test of Nonverbal Intelligence, 4th Edition
Key exclusion criteria (8 listed)
- Reported significant medical history
- Psychological or emotional disorder
- History of frank neurological injury
- Known speech, language, or learning disorder(s) other than stuttering
- Reading difficulties
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 |
|---|---|---|
| Threat-related stimulus exposureParticipants will view threat-related stimuli (words or faces) paired with nonthreat matches in three related experimental paradigms. | Behavioural | Eye tracking tasks |
Primary outcome
Reaction time (RT) measures
Time frame: Trial duration (maximum of 10 seconds)
A) A key outcome measure from the dot-probe task will consist of RTs for congruent trials (in which probe appears in the location of threat stimulus) vs. incongruent trials (probe replaces neutral stimulus). (B) Key outcome measure from the emotional Stroop will include RT for threat vs. neutral words.
Total dwell time on threat
Time frame: Trial duration (8 seconds)
This primary (and most reliable) index of AB will be extracted from eye movement data and represents the total duration of all fixations to areas of interest with threat stimuli for each trial of the free-viewing task.
1 secondary outcome
Eye tracking indices of AB
Time frame: Trial duration (8 seconds)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Individual participant dataSharing planned: No. Data will be made freely and publicly available on OSF (https://osf.io) together with our publications, with prior Institutional Review Board approval. Archived data will also be made available to other researchers upon request (by emailing the PI) and without cost. A signed data-sharing agreement will be required for researchers to access data; the agreement will stipulate that shared data must be used solely for the purpose of research, must not be transferred to or shared with others, must not be manipulated for the purpose of identifying subjects, and that the planned research must be reviewed and approved by an Institutional Review Board.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Threat-related stimulus exposure in people with Stuttering, Adult, run by University of Memphis 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 9 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 21 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reaction time (RT) measures (time frame: Trial duration (maximum of 10 seconds)). The study lists 2 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 21 May 2024.