WHO trial registration data set
| Data category | Information |
|---|---|
| Primary registry and trial identifying number | clinicaltrials.gov NCT02608333 |
| Date of registration in primary registry | 11 May 2015 |
| Secondary identifying numbers | French institutional review board (2015–013B) sponsor (69HCL15_0278) |
| Source of monetary or material support | French Ministry of Health (Programme de Recherche sur la Performance du Système de soins) Fondation de France (member of the Network of European Foundations for Innovative Cooperation) |
| Primary sponsor | Centre Hospitalier Le Vinatier, Bron, France |
| Secondary sponsor | Not applicable |
| Contact for public queries | Marie-Maude Geoffray (PI), email: marie-maude.geoffray @ch-le-vinatier.fr Sandrine Touzet, email: sandrine.touzet@chu-lyon.fr Amelie Zelmar, email: amelie.zelmar@chu-lyon.fr |
| Contact for scientific queries | Marie-Maude Geoffray (PI), email: marie-maude.geoffray @ch-le-vinatier.fr Sandrine Touzet (scientific contact), email: sandrine.touzet@chu-lyon.fr |
| Public title | Impact of the Early Start Denver Model (ESDM) on the cognitive level of children with autism spectrum disorder. |
| Scientific title | Impact of the ESDM on the cognitive level of children with autism spectrum disorder: study protocol for a randomised controlled trial using a two-stage Zelen design. IDEA study. |
| Countries of recruitment | France and Belgium |
| Health condition or problem studied | Autism spectrum disorder (ASD) |
| Interventions | Intervention: ESDM for toddlers and young children with ASD Description: ESDM delivered by trained therapists 10 hours per week at the intervention unit and 2 hours per week in the toddlers' natural environment (home, nursery, preschool). Control: care available in the community, i. e. consultations with a psychologist or child and adolescent psychiatrist, speech and language therapy, occupational therapy, individual or group psychotherapy. |
| Key inclusion and exclusion criteria | Age: between 15 and 36 months Sex: male or female Inclusion criteria: diagnosis of ASD (Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition, and Autism Diagnosis Observation Schedule), DQ of 30 or above at the MSEL, family living within 40 min of an ESDM unit. Exclusion criteria: serious neurological or physical condition, diagnosis of Rett syndrome, family unavailable for a regular follow-up and intervention. |
| Study type | Interventional Allocation: randomised 1:2; parallel assignment; blinding: assessor blind; two-stage modified Zelen design |
| Date of first enrolment | NA |
| Target sample size | 180 |
| Recruitment Status | NA |
| Primary outcome | Change in developmental quotient (DQ) measured using the MSEL, scored at 24 months |
| Key secondary outcomes | Child development, autism symptoms, quality of life of parents, healthcare resource use. |