Developmental and sequenced one-to-one educational intervention (DS1-EI) for autism spectrum disorder and intellectual disability: a two-year interim report of a randomized single-blind multicenter controlled trial

Abstract

Background: Children with autism spectrum disorder (ASD) and moderate to severe intellectual disability (ID) face many challenges. There is little evidence-based research into educational settings for children with ID and ASD and in France. Little is known about how this unserved population could benefit from intervention and education. This study assessed the feasibility and efficacy of a new intervention model using an individualized educational approach.

Methods: We conducted a randomized, single-blind controlled trial to assess a novel intervention: the "Developmental and Sequenced One-to-One Intervention (DS1-EI)". In DS1-EI, trained teachers worked one-to-one with each child in a small classroom setting, offering 10 h per week of the intervention. The focus was on encouraging spontaneous communication, promoting skills through play with peers, supporting positive interactions, and developmental and sequenced learning. We enrolled 5- to 9-year-old children with ASD and ID across 11 French child care institutions for children with co-occurring ASD and ID. Participants were matched in dyads by developmental quotient and randomized to the treatment-as-usual (TAU) group or the DS1-EI group. Independent raters blindly assessed the primary variables: The Childhood Autism Rating scale (CARS) and the Psychoeducational Profile, third edition (PEP-3). The secondary variables included the Vineland Adaptive Behavior Scale II (VABS-II) and the Clinical Global Assessment Scale (CGAS). Here we perform interim analyses at 24 months.

Results: At baseline, 72 participants were randomized. Nine patients (5 in the DS1-EI group and 4 in the TAU group) dropped out of the study. Using linear mixed models, both intent-to-treat (ITT) and per-protocol (PP) analyses at the 12-, 18- and 24-month outcomes showed no significant group nor group-by-time interaction effects. However, we found significant improvements in most primary and secondary variables over time in both groups.

Conclusions: The study did not show that DS1-EI was superior to TAU in treating children with ASD and ID over 24 months. However, the low dropout rate shows that DS1-EI is feasible, and well accepted. As the study is still ongoing, we need to wait for data at 36 months to ensure whether DS1-EI could be recommended.

Trial registration: ANSM130282B-31 (April 16, 2013) and ACTRN12616000592448. Registered 6 May 2016, retrospectively registered, http://www.anzctr.org.au/.

Keywords: Autism; Developmental intervention; Intellectual disability; Randomized controlled trial; Special education.

Fig. 1

Schedule of assessments for the DS1-EI trial. ADI-R = Autism Diagnostic Interview-Revised; CARS=Childhood Autism Rating Scale; CGI=Clinical Global Impression; CGAS=Clinical Global Assessment Score; PEP-3 = Psychoeducational Profile, 3rd Edition; DQ = Developmental Quotient; KAB-C=Kaufmann Assessment Battery for Children

Fig. 2

DS1-EI setting. a An example of one DS1-EI classroom: 1. Child’s and adult’s desk and chairs; 2. Child’s screen with pictograms; 3. The large table for mid-session group collaboration; (b) Each child is assigned a desk and two chairs (one for the child, one for the adult working with the child). During the learning sessions, the child sits with his back close to the wall. The adult working with the child sits facing the child. Written informed consent was obtained from the parents for the publication of this image

Fig. 3

Diagram flow of the study

Fig. 4

Changes in primary variables from baseline to 18 months in the DS1-EI and the TAU groups. DS1-EI: Developmental and Sequenced One-to-One Educational Intervention; TAU: Treatment as usual; CARS=Childhood Autism Rating Scale; PEP-3 = Psychoeducational Profile, 3rd Edition

Fig. 5

Changes in secondary variables from baseline to 12 and 24 months in the DS1-EI and the TAU groups. DS1-EI: Developmental and Sequenced One-to-One Educational Intervention; TAU: Treatment as usual; VABS: Vineland adaptive behavior scale; CGAS: Clinical global assessment score