NCT06422442

Brief 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). 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?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress95%
Sep 2023Jun 2026

Study Start

First participant enrolled

September 11, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 21, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

May 21, 2024

Status Verified

May 1, 2024

Enrollment Period

2.1 years

First QC Date

May 13, 2024

Last Update Submit

May 15, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Trial duration (8 seconds)

Secondary Outcomes (1)

  • Eye tracking indices of AB

    Trial duration (8 seconds)

Study Arms (1)

Eye tracking tasks

EXPERIMENTAL

All participants complete three tasks in which they view threat-related and neutral stimuli (words or faces)

Behavioral: Threat-related stimulus exposure

Interventions

Participants will view threat-related stimuli (words or faces) paired with nonthreat matches in three related experimental paradigms.

Eye tracking tasks

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Self-identification as a person who stutters
  • Score of at least 11 (mild stuttering) on Stuttering Severity Index, 4th Edition

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Memphis

Memphis, Tennessee, 38152, United States

RECRUITING

MeSH Terms

Conditions

Stuttering

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Individuals reviewing and coding data will not be aware of group status or diagnoses for participants.
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2024

First Posted

May 21, 2024

Study Start

September 11, 2023

Primary Completion

October 30, 2025

Study Completion (Estimated)

June 30, 2026

Last Updated

May 21, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

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.

Locations