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

• Register: ANZCTR
• Last refreshed on: 21 June 2021
• Main ID: ACTRN12616000592448
• Date of registration: 06/05/2016
• Prospective Registration: No
• Primary sponsor: Croix Rouge Francaise
• Public title: Developmental and sequenced 1 to 1 educational intervention in children with autism spectrum disorder (ASD): a randomized controlled trial.
• Scientific title: Developmental and sequenced one to one educational intervention (DS1-EI) for autism spectrum disorder: a randomized single-blind controlled trial.
• Date of first enrolment: 13/05/2013
• Target sample size: 70
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12616000592448.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

France

Contacts

• Name: Mrs Delphine Le Molgat

• Name: Prof David Cohen

Key inclusion & exclusion criteria

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.

Age minimum: 5 Years
Age maximum: 9 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Mental Health - Autistic spectrum disorders

Autism Spectrum Disorder ;Intellectual disability;
Autism Spectrum Disorder
Intellectual disability

Intervention(s)

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 parti

Primary Outcome(s)

Change in the Psycho-educational profile-3 (PEP-3) score[Baseline (T0), T18 and T36 months post intervention completion]

Secondary Outcome(s)

Change in Children Autism Rating scale (CARS) score[Baseline (T0), T18 and T36 months post intervention completion]

Change in cognitive functioning, assessed using Kaufman Neuropsychological testing (K-ABC) scores[Baseline (T0), T18 and T36 months post intervention completion]

Change in School assessment scores.
The school assessment score follows the curriculum that was adapted from the French program for nursery and primary schools and handiscol principles (http://eduscol.education.fr). It lists a series of abilities that are checked and define as acquired (2 points), being aquired (1 point) and not aquired (0 point).
Regarding academic/educational objectives, they are grouped in four domains: mathematics, language and communication; intermodality and autonomy leading to four scores that are the sum of all the points generated by the specific skills belonging to the corresponding domain.[Baseline (T0), T12, T24 and T36 months post intervention completion]

Change in Clinical Global Impression (CGI) severity and improvement scores based on clinician's assessment[Baseline (T0), T12, T18, T24 and T36 months post intervention completion]

Change in general functioning assessed using the Child-Global Assessment Functioning (C-GAS) score[Baseline (T0), T12, T18, T24 and T36 months post intervention completion]

Change in Vineland II Communication, Adaptation, Socialization and Daily living skills
scores[Baseline (T0), T12, T24 and T36 months post intervention completion]

Secondary ID(s)

ANSM No. 130282B-31

Source(s) of Monetary Support

Fondation Bettencourt-Schueller

Fondation EDF

Croix Rouge Francaise

Caisse Nationale de Solidarite pour l’Autonomie (CNSA)

Secondary Sponsor(s)

Programme de Recherches et d'Etudes sur l'Autisme

Ethics review

Status: Approved
Approval date: 07/05/2013
Contact: