Clinical trial NCT06116552: More and Less Social Comprehension
Official title: More and Less Social Comprehension: Child and Text Factors for Autistic Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Autism
Social Communication
Listening Comprehension
Reading Comprehension
Language
Individual Differences
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
name: University of Kansas
First posted: 2023-11-03
Enrollment: 50
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A within-subjects design is used where participants complete both treatments: listening to more social stories and less social stories.
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this early Phase 1 clinical trial is to assess if the social content of a story impacts autistic children's listening comprehension of stories. The main questions this study aims to answer are:

* Does removing social content from a story improve listening comprehension in autistic children?
* Does listening comprehension of more social versus less social stories differentially predict performance on a standardized reading comprehension measure?

Participants will listen to more social and less social stories while viewing accompanying pictures and answer comprehension questions about the stories and complete a standardized assessment of reading comprehension. In addition, participants complete measures of their nonverbal cognition, hearing status, autism severity, language abilities, and social communication abilities to help characterize individual differences in participants.

Detailed description: Listening comprehension is an important predictor of later reading comprehension, academic success, health, psychosocial, and vocational outcomes; yet roughly 65% of autistic school-age children have poor comprehension. Non-autistic comprehension of more social (e.g., narrative) texts is better than less social (e.g., expository texts) because non-autistic individuals can bootstrap their real-world social understanding to better understand the text. In contrast, autistic comprehension of less social texts has been shown in a small pilot study to be better than more social texts, which is likely due to their social communication impairments. The Construction-Integration Theory of Comprehension stipulates that a situation model (i.e., a mental representation) is constructed through interactions between child factors (i.e., individual differences in a child's abilities) and text factors (i.e., individual differences across texts). Both linguistic child factors (e.g., vocabulary and morphosyntax) and social child factors (e.g., social communication and theory of mind) predict reading comprehension in autistic children. However, these factors have not been examined for listening comprehension in autistic children and have only been examined for more social texts. Text factors (e.g., word concreteness and narrativity) impact comprehension in non-autistic individuals but have all but been ignored for autistic individuals.

The goal of this study is to examine how social information in texts impacts listening comprehension of stories in 9- to 12-year-old autistic children. Further, how listening comprehension of more or less social stories predicts reading comprehension on a standardized reading comprehension measure will also be assessed. In addition, individual differences in cognition, language, and social communication will be evaluated to determine how individual differences across children impacts comprehension and may predict response to intervention in future studies. The primary hypothesis is that stories with less social content (i.e, less social texts) will improve comprehension in autistic children compared to stories with more social content (i.e., more social texts). The secondary hypothesis is that comprehension or more social stories will better predict reading comprehension performance because these measures tend to include stories with more social information. In addition, both child and text factors impact comprehension and that social and linguistic child and text factors differentially contribute, depending on the content of the text. That is, the linguistic factors will predict comprehension across text type whereas the social factors will specifically predict comprehension of more social texts. The proposed project lays the methodological and empirical groundwork for using a precision medicine approach to identify and manipulate child and text factors for novel, effective comprehension interventions for autistic individuals.

After completing eligibility, participants will complete an experimental measure, the Socialness Story Task, that measures children's comprehension of more social and less social stories. Participants will also complete a standardized test of reading comprehension. In addition, participants will complete various experimental and standardized tests of nonverbal cognition, hearing status, autism severity, language, and social communication to assess individual differences. Participants complete all measures across two, 2.5 hour sessions.

Eligibility criteria: Inclusion Criteria:

* Has a community or educational autism diagnosis (based on parent report);
* Is between the ages of 9;0 to 12;11 (years; months);
* Uses verbal phrase-level spoken language (based on parent report).

Exclusion Criteria:

* Speaks more than one language (based on parent report);
* Has a known chromosomal abnormality (e.g., Fragile X syndrome, Down syndrome; based on parent report);
* Has an intellectual impairment or cognitive disability (IQ \< 70; based on parent report);
* Has Cerebral palsy (based on parent report);
* Uncorrected visual impairments (based on parent report);
* Minimal spoken language or no phrase spoken language (based on parent report or clinical observation).

Primary outcomes:
measure: Percent of correct comprehension questions for more social stories at baseline
timeFrame: Baseline
measure: Percent of correct comprehension questions for less social stories at baseline
timeFrame: Baseline
Secondary outcomes:
measure: Reading comprehension as measured by the Gray Oral Reading Test, Fifth Edition (GORT-5) at baseline
timeFrame: Baseline
Other outcomes:
Locations:
city: Lawrence
country: United States
facility: University of Kansas Comprehension and Language Learning Lab
state: Kansas
Study officials:
affiliation: University of Kansas Department of Speech-Language Hearing: Communications and Disorders
name: Meghan M Davidson, PhD, CCC-SLP
role: STUDY_DIRECTOR
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