Autism Spectrum Disorder Clinical Trial
— MLSCOfficial title:
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.
| Status | Recruiting |
| Enrollment | 50 |
| Est. completion date | December 2024 |
| Est. primary completion date | December 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 9 Years to 12 Years |
| Eligibility | 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). |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Kansas Comprehension and Language Learning Lab | Lawrence | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| University of Kansas Medical Center | National Institute on Deafness and Other Communication Disorders (NIDCD), University of Kansas |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Erratum In: Lancet. 2022 Dec 3;400(10367):1926. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 19 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | Reading comprehension as measured by the Gray Oral Reading Test, Fifth Edition (GORT-5) at 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05207956 -
App for Strengthening Services In Specialized Therapeutic Support
|
N/A | |
| Completed |
NCT03286621 -
Development of Eye-tracking Based Markers for Autism in Young Children
|
||
| Completed |
NCT02608333 -
Efficiency of Early Intervention for Autism Spectrum Disorder
|
N/A | |
| Recruiting |
NCT05935722 -
Evaluation of a Home-based Parenting Support Program: Parenting Young Children
|
N/A | |
| Active, not recruiting |
NCT06259539 -
A YouTube Curriculum for Children With Autism and Obesity
|
N/A | |
| Active, not recruiting |
NCT06303791 -
Digital-based Psychosocial Intervention for Parents of Children With Neurodevelopmental Disorders
|
N/A | |
| Enrolling by invitation |
NCT05017779 -
A Hybrid Effectiveness-implementation Trial of a High School-based Executive Function Treatment for Autistic Youth
|
N/A | |
| Completed |
NCT04772898 -
Effectiveness of a 6-week Hippotherapy Program in Children With Autism Spectrum Disorder
|
N/A | |
| Recruiting |
NCT04987541 -
The Therapeutic Effect of TBS Stimulation on Emotion Regulation in Autism Spectrum Disorder
|
N/A | |
| Completed |
NCT04308915 -
Mobile-based Games for Cognitive Training in Children With Neurodevelopmental Disorders
|
N/A | |
| Completed |
NCT06038435 -
The Effect of Cognitive Orientation Approach on Daily Occupational Performance With Autism Spectrum Disorder
|
N/A | |
| Terminated |
NCT04049981 -
Investigation of Mechanisms of Action in Superpower Glass
|
Phase 1/Phase 2 | |
| Completed |
NCT03693313 -
The Effect of CrossFit Kids on Social Skills in Children With Autism Spectrum Disorder (CrossFit KAMP)
|
N/A | |
| Recruiting |
NCT04107064 -
Achieving Steady Work Among Adults With Autism Through Specialized Employment Program
|
N/A | |
| Recruiting |
NCT03812068 -
Parent-mediated Developmental Behavioral Intervention
|
N/A | |
| Completed |
NCT03206996 -
Exposure Therapy for Auditory Sensitivity in Autism
|
N/A | |
| Completed |
NCT02299700 -
Study to Evaluate the Janssen Autism Knowledge Engine in Children and Adults With Autism Spectrum Disorder
|
N/A | |
| Completed |
NCT03422016 -
Electroretinogram in Autistic Spectrum Disorders
|
||
| Active, not recruiting |
NCT03548779 -
North Carolina Genomic Evaluation by Next-generation Exome Sequencing, 2
|
N/A | |
| Recruiting |
NCT05114538 -
Improving the Part C Early Intervention Service Delivery System for Children With ASD
|
N/A |