An interventional study of Threat-related stimulus exposure in Stuttering, Adult, sponsored by University of Memphis. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-21.
Sponsored by University of Memphis · Not applicable, Interventional, and Basic science
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?
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.
74 studies on the registry are indexed under Stuttering; 23 are open to participants now.
This study's planned enrollment of 80 is above the median of 44 across 57 interventional studies indexed under Stuttering.
Browse Stuttering studies →University of Memphis is the lead sponsor of 44 studies on the registry; 2 are open to participants now.
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Additional inclusion criteria for adults who stutter:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants complete three tasks in which they view threat-related and neutral stimuli (words or faces)
Behavioral: Threat-related stimulus exposure
Participants will view threat-related stimuli (words or faces) paired with nonthreat matches in three related experimental paradigms.
Reaction time (RT) measures
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.
Time frame: 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.
Time frame: Trial duration (8 seconds)
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).
Time frame: Trial duration (8 seconds)
Plan to share: 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.
No publications or documents are linked to this record.
Started Sep 2023 (actual). Primary completion is estimated for Oct 2025, 25 months after the start.
Of 37 interventional studies with no phase under Stuttering, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 38. This study's planned 25 months is below that.
How these figures are worked out, and which studies are left out of them.
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University of Memphis