Recruiting

Observational Study

Sponsor:

University of Kansas Medical Center

Code:

NCT06116552

Conditions

Autism Spectrum Disorder

Eligibility Criteria

Sex: All

Age: 9 - 12

Healthy Volunteers: Not accepted

Interventions

More Social Stories

Less Social Stories

Study Details

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.

Conditions

Autism Spectrum Disorder

Study ID

NCT06116552

Start date

Jul 10, 2023

Status verified date

Apr, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Jul, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 9 - 12

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: More and Less Social Comprehension

Participants listen to more social and less social comprehension stories and answer comprehension questions about the stories.

Interventions

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.

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.

Primary outcome measure

  • Percent of correct comprehension questions for more social stories at baseline [ Time Frame: Baseline ]
  • Percent of correct comprehension questions for less social stories at baseline [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Meghan M Davidson, PhD, CCC-SLP

785-864-6430meghan.davidson@ku.edu

Thomas Gottstein

785-864-6037call_lab@ku.edu

Locations

University of Kansas Comprehension and Language Learning Lab

Recruiting

Lawrence, Kansas, United States, 66045

Contacts

Thomas Gottstein

785-864-6037call_lab@ku.edu

Meghan M Davidson, PhD, CCC-SLP

785-864-6430meghan.davidson@ku.edu

Principal Investigator:

Meghan M Davidson, PhD, CCC-SLP

More Information

Sponsor

University of Kansas Medical Center

Last update posted

Apr 4, 2025

Last verified

Apr, 2025

Keywords

  • Autism
  • Social Communication
  • Listening Comprehension
  • Reading Comprehension
  • Language
  • Individual Differences

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2025-04-04.