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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/.

SUBMITTER: Tanet A

PROVIDER: S-EPMC7260851 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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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.

Tanet Antoine A Hubert-Barthelemy Annick A Clément Marie-Noëlle MN Soumille François F Crespin Graciela C GC Pellerin Hugues H Allaert François-André FA Cohen David D Saint-Georges Catherine C

BMC pediatrics 20200529 1

<h4>Background</h4>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.<h4>Methods</h4>We conducted a r ...[more]

PMID: 32471387

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Project description:BackgroundChildren with autism spectrum disorder (ASD) and intellectual disability (ID) are an understudied population whose school inclusion is challenging.MethodsWe assessed the effects of "Developmental and Sequenced one-to-one Educational Intervention" (DS1-EI), a ten-hour-per-week adapted instruction programme for five- to nine-year-old children with ASD and ID treated in outpatient health care institutions. A single-blind multisite randomized controlled trial was conducted to compare DS1-EI given for three years with treatment as usual (TAU)(trial registration numbers: ANSM130282B-31 (April 16, 2013) and ACTRN12616000592448). The primary outcome was the change in the psycho-educational profile (PEP). Secondary variables included the Childhood Autism Rating Scale (CARS), Autism Diagnostic Interview-Revised (ADI-R), Vineland Adaptive Behaviour Scale-II (VABS-II), Children's Global Assessment Scale (CGAS) and annual assessment of educational achievement. Statistical analyses used linear mixed models.FindingsSeventy-two participants with severe ASD and ID were recruited. Intention-to-treat and per-protocol analyses showed no significant group*time interaction for the PEP, CARS, ADI-R, VABS-II and CGAS but a significant effect for educational achievement with a better improvement in the DS1-EI group. At the 36-month time point, more DS1-EI children were included in mainstream classrooms. Additional analyses using multivariate models taking into account moderating variables at the baseline (e.g., Developmental Quotient) confirmed that DS1-EI had a significant effect on educational outcomes.InterpretationDS1-EI did not improve communication or social skills in children with ASD and ID compared with TAU. However, DS1-EI enhanced school skills in four domains (language, mathematics, inter modality, and school autonomy) favouring inclusion in mainstream classrooms more than TAU. Providing such adapted instruction is feasible and should be encouraged.FundingCNSA; Fondation Bettencourt-Schueller; Fondation EDF.

Project description:IntroductionIndividuals with autism spectrum disorder (ASD) who also exhibit severe-to-moderate ranges of intellectual disability (ID) still face many challenges (i.e., less evidence-based trials, less inclusion in school with peers).MethodsWe implemented a novel model called the "Developmental and Sequenced One-to-One Educational Intervention" (DS1-EI) in 5- to 9-year-old children with co-occurring ASD and ID. The treatment protocol was adapted for school implementation by designing it using an educational agenda. The intervention was based on intensity, regular assessments, updating objectives, encouraging spontaneous communication, promoting skills through play with peers, supporting positive behaviors, providing supervision, capitalizing on teachers' unique skills, and providing developmental and sequenced learning. Developmental learning implies that the focus of training is what is close to the developmental expectations given a child's development in a specific domain. Sequenced learning means that the teacher changes the learning activities every 10-15 min to maintain the child's attention in the context of an anticipated time agenda. We selected 11 French institutions in which we implemented the model in small classrooms. Each institution recruited participants per dyads matched by age, sex, and developmental quotient. Patients from each dyad were then randomized to a DS1-EI group or a Treatment as usual (TAU) group for 36 months. The primary variables - the Childhood Autism Rating scale (CARS) and the psychoeducational profile (PEP-3) - will be blindly assessed by independent raters at the 18-month and 36-month follow-up.Discussion and baseline descriptionWe enrolled 75 participants: 38 were randomized to the DS1-EI and 37 to the TAU groups. At enrollment, we found no significant differences in participants' characteristics between groups. As expected, exposure to school was the only significant difference [9.4 (±4.1) h/week in the DS1-EI group vs. 3.4 (±4.5) h/week in the TAU group, Student's t-test, t = 5.83, p < 0.001].Ethics and disseminationThe protocol was authorized by the competent national regulatory authority (Agence nationale de sécurité du médicament et des produits de santé) and approved by the local Ethics Committee (Comité de Protection des Personnes) at the University Hospital Saint-Antoine (May 7, 2013). The findings will be disseminated through peer-reviewed journals and national and international conferences.Trial registration numbersANSM130282B-31 (April 16 2013) and ACTRN12616000592448 (May 6 2016).

Dataset Information

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.

Publications

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.

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