Using Neuroimaging and Behavioral Assessments to Understand Late Talking
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-30
SponsorUniversity of Toronto
About this trial
Late talkers (LT), representing 10-20% of children under 3, demonstrate hallmark syntax and vocabulary deficits similar to preschoolers with developmental language disorder. While effective and early interventions can mitigate the impact of late talking, not enough is known about its neural basis, yet is needed to inform the design of more individualized interventions. This proposed effort uses neuroimaging, along with behavioral methods, with the goal of better understanding the memory-language mechanisms that underlie learning and late talking, while also considering their association to treatment-related changes in LT.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
child and parent are monolingual/native (primarily) English speakers
child is enrolled at one of the participating facilities
child is recruited via word of mouth, including social media
child is between 18 and 30 months of age
Disqualifiers
Child does not meet criteria for LT or typical development
Standard magnetic resonance imaging exclusion criteria
Gestational age less than 37 weeks or greater than 42 weeks
Special education placement of child based on ability or behavior
Trial design
Design model
Parallel
Treatments tested in this trial
Intervention to address late talking
Behavioralthis intervention is designed to support both speech and language development in children who are toddlers. Given the age group of children their parents are part of the intervention program. Importantly the frequency of the intervention can range from once to twice per week, with timing also designed to complement the particular agency
Treatment groups
45 Participants
are divided into 2 treatment groupsGroup A: Intervention to address late talkingExperimental treatment 1 intervention
Group B: Waitlist controlsNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Aim 1/Pre - Structural connectivity data using diffusion imaging
Connectivity data (density of streamlines connecting regions of the procedural learning and declarative networks) will be measured using tractography, a 3D modeling technique, to visually represent nerve tracts using data that are collected using diffusion MRI from each of the 45 participants at Weeks 1 to 2 as part of a non-sedated sleep scan.
Time frame
Weeks 1 to 2 (Time 1/pre)2
Aim 2/Pre - Changes in structural connectivity data using diffusion imaging
Changes in connectivity data (density of streamlines connecting regions of the procedural learning and declarative networks) calculated using data collected over two time points (pre to post; post to followup) will be measured from each of the 45 participants. Connectivity data measured using tractography collected using diffusion MRI are gathered from these participants at pre, post, and followup to inform these changes over time as part of a non-sedated sleep scan.
Time frame
Weeks 1 to 8 or 9 (pre to post); Weeks 10 to 17 or 18 (post to followup)Secondary outcomes
1
Aim 1/Pre - Raw score on the MacArthur Bates Communicative Development Inventories: Words and Sentences- (first set)
Raw score data calculated using the MacArthur Bates Communicative Development Inventories: Words and Sentences. This measure is completed by each of the 45 children's parents. High scores indicate better performance compared to lower scores. Minimum score is '0' and maximum is '680'. These data serve as main secondary outcomes.
Time frame
Weeks 1 to 2 (Time 1/pre - first set)2
Aim 1 - Raw score on the Focus on the Outcomes of Communication Under Six Parent Version- (second set)
Raw score data calculated using the Focus on the Outcomes of Communication Under - Parent Version. This measure is completed by each of the 45 children's parents. High scores indicate better performance compared to lower scores. Minimum score is '0' and maximum is '238'. These data will inform main secondary outcomes.
Time frame
Weeks 1 to 2 - (Time 1/pre - second set)3
Aim 1/Pre - Raw score on the Focus on the Outcomes of Communication Under Six Clinician Version- (third set)
Raw score data calculated using the Focus on the Outcomes of Communication Under - Clinician Version. This measure is completed by each of the 45 children's clinicians. High scores indicate better performance compared to lower scores. Minimum score is '0' and maximum is '238'. These data will inform main secondary outcomes.
Time frame
Weeks 1 to 2 - (Time 1/pre - third set)4
Aim 1/Pre - Raw score on the Intelligibility in Context Scale- (fourth set)
Raw score data calculated using the Intelligibility in Context Scale. This measure is completed by each of the 45 children's parents. High scores indicate better performance compared to lower scores. Minimum score is '0' and maximum is '35'. These data will inform additional secondary outcomes.
Time frame
Weeks 1 to 2 - (Time 1/pre - fourth set)Other outcomes
1
Aim 1/Pre - qualitative data clinician reported
Other outcomes using themes from qualitative questions to the clinicians of the 45 participants. Scores on a scale are not used in this qualitative effort.
Time frame
Weeks 1 to 2 (Pre/Time 1)2
Aim 1/Pre - qualitative data parent reported
Other outcomes using themes from qualitative questions to the parents of each of the 45 participants. Scores on a scale are not used in this qualitative effort.
Time frame
Weeks 1 to 2 (Pre/Time 1)3
Aim 2 - Qualitative data parent reported
Other outcomes using themes from qualitative questions to the parents of each of the 30 children who are late talkers. These qualitative data are collected at three time points: pre, post, followup. Scores on a scale are not used in this qualitative effort.
Time frame
Weeks 1 or 2 (pre/Time 1); Weeks 9 or 10 (post/Time 2), Weeks 17 or 18 (followup/Time 3)4
Aim 2 - qualitative data clinician reported
Other outcomes using themes from qualitative questions to the clinicians of the 30 children who are late talkers. These qualitative data are collected at three time points: pre, post, followup. Scores on a scale are not used in this qualitative effort.
Time frame
Weeks 1 or 2 (pre/Time 1); Weeks 9 or 10 (post/Time 2), Weeks 17 or 18 (followup/Time 3)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Toronto
Lead sponsor
Holland Bloorview Kids Rehabilitation Hospital
Collaborator
Children's Hospital Medical Center, Cincinnati
Collaborator
University of Cincinnati
Collaborator
Georgetown University
Collaborator
Source ClinicalTrials.gov