NCT06116552

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 10, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 3, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

April 4, 2025

Status Verified

April 1, 2025

Enrollment Period

2 years

First QC Date

October 30, 2023

Last Update Submit

April 1, 2025

Conditions

Keywords

AutismSocial CommunicationListening ComprehensionReading ComprehensionLanguageIndividual Differences

Outcome Measures

Primary Outcomes (2)

  • Percent of correct comprehension questions for more social stories at 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

    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 Outcomes (1)

  • Reading comprehension as measured by the Gray Oral Reading Test, Fifth Edition (GORT-5) at baseline

    Baseline

Study Arms (1)

More and Less Social Comprehension

EXPERIMENTAL

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

Behavioral: More Social StoriesBehavioral: Less Social Stories

Interventions

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.

More and Less Social Comprehension

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.

More and Less Social Comprehension

Eligibility Criteria

Age9 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Comprehension and Language Learning Lab

Lawrence, Kansas, 66045, United States

RECRUITING

Related Publications (19)

  • Bodner KE, Engelhardt CR, Minshew NJ, Williams DL. Making Inferences: Comprehension of Physical Causality, Intentionality, and Emotions in Discourse by High-Functioning Older Children, Adolescents, and Adults with Autism. J Autism Dev Disord. 2015 Sep;45(9):2721-33. doi: 10.1007/s10803-015-2436-3.

    PMID: 25821925BACKGROUND
  • Chevallier C, Parish-Morris J, McVey A, Rump KM, Sasson NJ, Herrington JD, Schultz RT. Measuring social attention and motivation in autism spectrum disorder using eye-tracking: Stimulus type matters. Autism Res. 2015 Oct;8(5):620-8. doi: 10.1002/aur.1479. Epub 2015 Jun 10.

    PMID: 26069030BACKGROUND
  • Davidson MM. Reading Comprehension in School-Age Children With Autism Spectrum Disorder: Examining the Many Components That May Contribute. Lang Speech Hear Serv Sch. 2021 Jan 19;52(1):181-196. doi: 10.1044/2020_LSHSS-20-00010. Epub 2021 Jan 18.

    PMID: 33464982BACKGROUND
  • Davidson MM, Ellis Weismer S. Characterization and prediction of early reading abilities in children on the autism spectrum. J Autism Dev Disord. 2014 Apr;44(4):828-45. doi: 10.1007/s10803-013-1936-2.

    PMID: 24022730BACKGROUND
  • Davidson MM, Ellis Weismer S. Reading comprehension of ambiguous sentences by school-age children with autism spectrum disorder. Autism Res. 2017 Dec;10(12):2002-2022. doi: 10.1002/aur.1850. Epub 2017 Aug 22.

    PMID: 28834327BACKGROUND
  • Davidson MM, Fleming KK. Story Comprehension Monitoring Across Visual, Listening, and Written Modalities in Children with and Without Autism Spectrum Disorder. J Autism Dev Disord. 2023 Jan;53(1):1-24. doi: 10.1007/s10803-021-05418-6. Epub 2022 Jan 7.

    PMID: 34994926BACKGROUND
  • Davidson MM, Kaushanskaya M, Ellis Weismer S. Reading Comprehension in Children With and Without ASD: The Role of Word Reading, Oral Language, and Working Memory. J Autism Dev Disord. 2018 Oct;48(10):3524-3541. doi: 10.1007/s10803-018-3617-7.

    PMID: 29802485BACKGROUND
  • Devine RT, Hughes C. Silent films and strange stories: theory of mind, gender, and social experiences in middle childhood. Child Dev. 2013 May-Jun;84(3):989-1003. doi: 10.1111/cdev.12017. Epub 2012 Nov 30.

    PMID: 23199139BACKGROUND
  • Devine RT, Hughes C. Measuring theory of mind across middle childhood: Reliability and validity of the Silent Films and Strange Stories tasks. J Exp Child Psychol. 2016 Sep;149:23-40. doi: 10.1016/j.jecp.2015.07.011. Epub 2016 Feb 5.

    PMID: 26255713BACKGROUND
  • Eason SH, Goldberg LF, Young KM, Geist MC, Cutting LE. Reader-Text Interactions: How Differential Text and Question Types Influence Cognitive Skills Needed for Reading Comprehension. J Educ Psychol. 2012 Aug;104(3):515-528. doi: 10.1037/a0027182.

    PMID: 26566295BACKGROUND
  • Graesser AC, McNamara DS. Computational analyses of multilevel discourse comprehension. Top Cogn Sci. 2011 Apr;3(2):371-98. doi: 10.1111/j.1756-8765.2010.01081.x.

    PMID: 25164300BACKGROUND
  • Judd CM, Westfall J, Kenny DA. Experiments with More Than One Random Factor: Designs, Analytic Models, and Statistical Power. Annu Rev Psychol. 2017 Jan 3;68:601-625. doi: 10.1146/annurev-psych-122414-033702. Epub 2016 Sep 28.

    PMID: 27687116BACKGROUND
  • Kim YG. Toward Integrative Reading Science: The Direct and Indirect Effects Model of Reading. J Learn Disabil. 2020 Nov/Dec;53(6):469-491. doi: 10.1177/0022219420908239. Epub 2020 Mar 3.

    PMID: 32125226BACKGROUND
  • Lord C, Charman T, Havdahl A, Carbone P, Anagnostou E, Boyd B, Carr T, de Vries PJ, Dissanayake C, Divan G, Freitag CM, Gotelli MM, Kasari C, Knapp M, Mundy P, Plank A, Scahill L, Servili C, Shattuck P, Simonoff E, Singer AT, Slonims V, Wang PP, Ysrraelit MC, Jellett R, Pickles A, Cusack J, Howlin P, Szatmari P, Holbrook A, Toolan C, McCauley JB. The Lancet Commission on the future of care and clinical research in autism. Lancet. 2022 Jan 15;399(10321):271-334. doi: 10.1016/S0140-6736(21)01541-5. Epub 2021 Dec 6. No abstract available.

    PMID: 34883054BACKGROUND
  • McIntyre NS, Solari EJ, Gonzales JE, Solomon M, Lerro LE, Novotny S, Oswald TM, Mundy PC. The Scope and Nature of Reading Comprehension Impairments in School-Aged Children with Higher-Functioning Autism Spectrum Disorder. J Autism Dev Disord. 2017 Sep;47(9):2838-2860. doi: 10.1007/s10803-017-3209-y.

    PMID: 28624962BACKGROUND
  • Nation K, Clarke P, Wright B, Williams C. Patterns of reading ability in children with autism spectrum disorder. J Autism Dev Disord. 2006 Oct;36(7):911-9. doi: 10.1007/s10803-006-0130-1.

    PMID: 16897396BACKGROUND
  • Peristeri E, Baldimtsi E, Andreou M, Tsimpli IM. The impact of bilingualism on the narrative ability and the executive functions of children with autism spectrum disorders. J Commun Disord. 2020 May-Jun;85:105999. doi: 10.1016/j.jcomdis.2020.105999. Epub 2020 May 3.

    PMID: 32413648BACKGROUND
  • Ricketts J, Jones CR, Happe F, Charman T. Reading comprehension in autism spectrum disorders: the role of oral language and social functioning. J Autism Dev Disord. 2013 Apr;43(4):807-16. doi: 10.1007/s10803-012-1619-4.

    PMID: 22843036BACKGROUND
  • Westerveld MF, Filiatrault-Veilleux P, Paynter J. Inferential narrative comprehension ability of young school-age children on the autism spectrum. Autism Dev Lang Impair. 2021 Sep 7;6:23969415211035666. doi: 10.1177/23969415211035666. eCollection 2021 Jan-Dec.

    PMID: 36531336BACKGROUND

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic DisorderCommunicationLanguage

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersBehavior

Study Officials

  • Meghan M Davidson, PhD, CCC-SLP

    University of Kansas Department of Speech-Language Hearing: Communications and Disorders

    STUDY DIRECTOR

Central Study Contacts

Meghan M Davidson, PhD, CCC-SLP

CONTACT

Thomas Gottstein

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: A within-subjects design is used where participants complete both treatments: listening to more social stories and less social stories.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 30, 2023

First Posted

November 3, 2023

Study Start

July 10, 2023

Primary Completion

July 1, 2025

Study Completion

December 1, 2025

Last Updated

April 4, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
IPD may be shared at any point during participant recruitment, during data analysis, or after data analysis has been completed.
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

Locations