A Randomized Trial of Direct Instruction Language for Learning in Children With Autism Spectrum Disorder

Lawrence Scahill; M Alice Shillingsburg; Opal Ousley; Moira L Pileggi; Rebecca L Kilbourne; Derianne Buckley; Scott E Gillespie; Courtney McCracken

doi:10.1016/j.jaac.2021.11.034

A Randomized Trial of Direct Instruction Language for Learning in Children With Autism Spectrum Disorder

J Am Acad Child Adolesc Psychiatry. 2022 Jun;61(6):772-781. doi: 10.1016/j.jaac.2021.11.034. Epub 2022 Jan 31.

Authors

Lawrence Scahill¹, M Alice Shillingsburg², Opal Ousley³, Moira L Pileggi⁴, Rebecca L Kilbourne⁴, Derianne Buckley⁴, Scott E Gillespie³, Courtney McCracken⁵

Affiliations

¹ Emory University School of Medicine and the Marcus Autism Center, Atlanta, Georgia. Electronic address: lawrence.scahill@emory.edu.
² May Institute, Randolph Massachusetts.
³ Emory University School of Medicine and the Marcus Autism Center, Atlanta, Georgia.
⁴ Marcus Autism Center, Atlanta, Georgia.
⁵ Kaiser Permanente, Atlanta, Georgia.

PMID: 35093490
DOI: 10.1016/j.jaac.2021.11.034

Abstract

Objective: To compare Direct Instruction Language for Learning (DI) plus treatment as usual (TAU) with TAU alone in children with autism spectrum disorder and moderate language delay.

Method: In this study, 83 children (age range, 4 years to 7 years 11 months) were randomly assigned to DI+TAU (n = 42) or TAU (n = 41) for 6 months. Trained therapists delivered DI in twice-weekly, 90-minute sessions for 24 weeks. The primary outcome was the standard score on the age-appropriate version of the Clinical Evaluation of Language Fundamentals (CELF). The key secondary measure was the proportion of children rated by a clinician blinded to treatment as "much improved" or "very much improved" on the Clinical Global Impressions-Improvement (CGI-I) scale.

Results: Attrition was 12%. At end point, DI+TAU participants showed a 4.8-point (8.1%) increase on CELF vs 2.3 points (4.1%) in TAU participants (difference = 2.55, p = .14, effect size = 0.25), rendering this a negative trial on the prespecified primary outcome. In post hoc analysis that adjusted for IQ, mean difference was 3.5 (p = .04, effect size = 0.33). On CGI-I, 54.8% (23/42) of DI+TAU participants were rated much improved or very much improved compared with 21.9% (9/41) of TAU participants (χ² = 9.4, p = .002). On the clinically meaningful threshold of >5 points on CELF, 55.5% of DI+TAU participants achieved this benchmark vs 29.3% of TAU participants (χ² = 3.6, p = .06). Complete CELF data were available for 72 participants. In the combined sample, baseline CELF scores ≤50 were associated with no improvement.

Conclusion: On CELF, DI+TAU did not meet the prespecified difference from TAU. When adjusted for IQ, DI+TAU was superior to TAU on CELF at end point. DI+TAU was superior to TAU on CGI-I.

Clinical trial registration information: Direct Instruction Language for Learning in Autism Spectrum Disorder; https://clinicaltrials.gov/; NCT02483910.

Keywords: autism; children; clinical trial; language delay.

Publication types

Randomized Controlled Trial
Research Support, U.S. Gov't, Non-P.H.S.
Research Support, Non-U.S. Gov't

MeSH terms

Autism Spectrum Disorder* / therapy
Child
Child, Preschool
Humans
Language
Learning
Treatment Outcome

Associated data

ClinicalTrials.gov/NCT02483910