More and Less Social Comprehension (MLSC)

April 1, 2025 updated by: Meghan M. Davidson, Ph.D., University of Kansas Medical Center

More and Less Social Comprehension: Child and Text Factors for Autistic Children

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Kansas
      • Lawrence, Kansas, United States, 66045
        • Recruiting
        • University of Kansas Comprehension and Language Learning Lab
        • Contact:
        • Contact:
        • Contact:
          • Meghan M Davidson, PhD, CCC-SLP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: More and Less Social Comprehension
Participants listen to more social and less social comprehension stories and answer comprehension questions about the stories.
Behavioral: More Social Stories
Children listen to four stories while looking at accompanying images that contain more social information (e.g., characters referencing, dialogue, mental and emotional state words, and narrativity) as measured by a text analysis.
Behavioral: Less Social Stories
Children listen to four stories while looking at accompanying images that contain less social information (e.g., characters referencing, dialogue, mental and emotional state words, and narrativity) as measured by a text analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of correct comprehension questions for more social stories at baseline
Time Frame: Baseline
The Socialness Story Comprehension Task assesses listening comprehension of more and less social stories. Participants listen to stories while looking at picture scenes and then answer three open-ended comprehension questions about each story. The participant is presented with two practice stories first, and then eight main stories. One practice story and four of the main stories are more social. Comprehension questions are scored as correct or incorrect. Participant scores may range from 0% (0 comprehension questions correct) to 100% (all 12 comprehension question correct). Higher scores are indicative of better comprehension of more social stories.
Baseline
Percent of correct comprehension questions for less social stories at baseline
Time Frame: Baseline
The Socialness Story Comprehension Task assesses listening comprehension of more and less social stories. Participants listen to stories while looking at picture scenes and then answer three open-ended comprehension questions about each story. The participant is presented with two practice stories first, and then eight main stories. One practice story and four of the main stories are less social. Comprehension questions are scored as correct or incorrect. Participant scores may range from 0% (0 comprehension questions correct) to 100% (all 12 comprehension question correct). Higher scores are indicative of better comprehension of less social stories.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reading comprehension as measured by the Gray Oral Reading Test, Fifth Edition (GORT-5) at baseline
Time Frame: Baseline
The Gray Oral Reading Test, Fifth Edition (GORT-5) is a standardized assessment that measures children's reading comprehension. The GORT-5 consists of up to16 stories that children read aloud and then answer comprehension questions about. Scaled scores for the comprehension score indicate very poor (scores between 1 to 3), poor (scores between 4 to 5), below average (scores between 6 to 7), average (scores between 8-12), above average (scores between 13 to 14), superior (scores between 15 to 16), and very superior (scores between 17 to 20) performance. Higher scores indicate better reading comprehension.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)
University of Kansas

Investigators

  • Study Director: Meghan M Davidson, PhD, CCC-SLP, University of Kansas Department of Speech-Language Hearing: Communications and Disorders

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2023

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

October 30, 2023

First Submitted That Met QC Criteria

October 30, 2023

First Posted (Actual)

November 3, 2023

Study Record Updates

Last Update Posted (Actual)

April 4, 2025

Last Update Submitted That Met QC Criteria

April 1, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00149319
  • R21DC020786 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The research team may need to share participant study data with people outside KUMC or KU-Lawrence. These groups or agencies may make copies of study data for audit purposes.

IPD Sharing Time Frame

IPD may be shared at any point during participant recruitment, during data analysis, or after data analysis has been completed.

IPD Sharing Access Criteria

Groups or agencies with whom we may share IPD include:

  • Federal agencies that oversee human research (if a study audit is performed)
  • Experts who inspect the study information to see if the study is being done correctly and if it is still safe to continue

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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