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Developmental and sequenced 1 to 1 educational intervention in children with autism spectrum disorder (ASD): a randomized controlled trial.

Developmental and sequenced one to one educational intervention (DS1-EI) for autism spectrum disorder: a randomized single-blind controlled trial.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000592448
Acronym
DS1-EI-ASD
Enrollment
72
Registered
2016-05-06
Start date
2013-05-13
Completion date
2014-06-02
Last updated
2021-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Despite improvements in the early treatment of children with Autism Spectrum Disorder (ASD), there are still many challenges to face in particular in individuals with ASD that also exhibit severe to moderate ranges of intellectual disability (ID). Based on previous research and the need to offer treatment in natural context such as school, we have developed a novel model named “Developmental and Sequenced one-to-one educational Intervention” (DS1-EI) to deliver 5-9 years children with co-occurring ASD and ID a treatment protocol adapted to school implementation because it is based on educational agenda (autonomy, communication, fine motor skills, mathematics). The major objectives of the study are (1) to select at least 10 French institutions to implement the treatment model; (2) to test the model during a randomized controlled trial over a period of 18 and 36 months. Each institution will recruit participants per dyads matched for age, sex and developmental quotient. Then patients will be randomized to DS1-EI group or Treatment as usual (TAU) group. During the rehabilitation period, only half of the children will participate in the experimental (DS1-EI) group model designed to improve their developmental abilities and decrease their autism symptoms. Controls will be allocated to TAU. Participants will be assessed at T12, T18, T24 and T36 with a selection of variables. We hope to show a better improvement in the experimental group.

Interventions

Based on what was learned from evidence-based studies, we have developed a novel model named “Developmental and Sequenced one-to-one educational Intervention” (DS1-EI) to deliver 5-9 years children with co-occurring ASD and ID a treatment protocol adapted to school implementation. The treatment protocol was adapted for school implementation by designing it using an educational agenda. The intervention is based on intensity, regular assessments, updating objectives, encouraging spontaneous commun

Based on what was learned from evidence-based studies, we have developed a novel model named “Developmental and Sequenced one-to-one educational Intervention” (DS1-EI) to deliver 5-9 years children with co-occurring ASD and ID a treatment protocol adapted to school implementation. The treatment protocol was adapted for school implementation by designing it using an educational agenda. The intervention is based on intensity, regular assessments, updating objectives, encouraging spontaneous communication, promoting skills through play with peers, supporting positive behaviours rather than tackling challenging behaviors, providing supervision, capitalizing on teachers’ unique skills, and providing developmental and sequenced learning. More specifficaly: (1) Participants randomized in the specific experimental protocol (DS1-EI group) receive 4 mornings per week (each session=2h30) of DS1-EI, while the rest of the week they continue to receive the usual protocol of each site. Given the school holiday calendar in France, participants will receive a maximum of 48 sessions by trimester and 150 sessions per year for a 3-year duration. (2) The setting is implemented in small classroom with 4 pupils and an adapted environment is proposed. Each child is offered a desk, two chairs (one for the child, one for the adult working with the child), a screen where pictures of the child’s schedule and activities are provided, and a locker with his picture. In contrast to TEACCH (Treatment and Education of Autistic and related Communication handicapped CHildren), The child is sitting with his back close to the wall where the screen stands. The setting includes also (i) a large table for mid-session group collation; (ii) a place offering benches and carpets where to group participants (both children and adults) at the beginning and ending of a session. (3) The program includes 10h of DS1-EI plus other therapeutic proposals according to each institution (e.g. occupational therapy; speech therapy; social skill group activities). (4) The program follows developmental rules meaning that training is focused on the nearest expected activity/skill of a given child’s development according to the considered domain. (5) In terms of timing, the program is sequenced in two ways. The 2h30 sessions follow an anticipated and structured agenda that is presented for each child on the screen. When a novel activity starts, the corresponding pictogram is shown on the child’s desk. Second, teachers are asked to change activities every 10-15 minutes to keep attention from the child and to help him improving in challenging sameness needs. (6) The program is also personalized and curriculum based and has specific educational objectives. Since DS1-EI is a program implemented in classrooms, both curriculum and objectives follow academic recommendations from the French Ministry for National Education. The curriculum was adapted from the French program for nursery and primary schools and handiscol principles (http://eduscol.education.fr). Performed activities are those recommended for persons with special needs and handicap. They are grouped in 4 domains: mathematics (e.g. organizing stickers), language (e.g. naming objects) and communication (e.g. improving joint attention), intermodality (e.g. using various tools such as paint, pastels, markers...) and autonomy (e.g. waiting one’s turn). (7) Each classroom for N children is under the responsibility of one ID-specilist teacher helped by (N-1) educational assistants according to the 1 to 1 need of the program. When activities change every 10-15 minutes, the adult supervising the child changes as well. So during a single session, each child interact in average 2 times with each adult. (8) Adherance and fidelity to the programme is monitored through a one week initial training and monthly supervision of each classroom teacher, assistants and childrens' educational agenda.

Sponsors

Croix Rouge Francaise
Lead SponsorCharities/Societies/Foundations

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
5 Years to 9 Years
Healthy volunteers
No

Inclusion criteria

Inclusion criteria : - a current diagnosis of ASD confirmed by clinical assessment and the Autism Diagnostic Interview-Revised; - a developmental quotient less than or equal to 24 months; - no fluent oral language - aged between 5 to 9 years. - Controls are matched for sex, age, IQ, study sites before randomization

Exclusion criteria

Exclusion criteria : - parents’ refusal to participate; - family project to change institution in the short term whatever the reason; - patient’s agitation, hyperactivity or behavioral problems that would challenge presence in classroom.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 1, 2026