Autism spectrum disorder Mental and Behavioural Disorders Childhood autism
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged between 2-4 at entry. 2. Nonverbal or minimally verbal, with fewer than 20 functional words (Kasari, Brady, Lord, & Tager-Flusberg, 2013). 3. Meet criteria for ASD on the Toddler Module of the ADOS-2 (Autism Diagnostic Observation Schedule, Second Edition; Esler et al., 2015; Luyster et al., 2009; Randall et al., 2018), and a clinical diagnosis based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5; American Psychiatric Association, 2013) criteria using all available information. 4. Willingness to complete the intervention.
Exclusion criteria
Exclusion criteria: 1. A neurodevelopmental disorder of known etiology (e.g., fragile X syndrome). 2. Significant sensory or motor impairment. 3. Major physical problems such as a chronic serious health condition. 4. Seizures at time of entry. 5. Use of psychoactive medications. 6. History of a serious head injury and/or neurologic disease. 7. Alcohol or drug exposure during the prenatal period. 8. Ratio IQ below 35 as measured by mean age equivalence score/chronological age on the visual reception and fine motor subscales of the Mullen Scales of Early Learning (Mullen, 1995).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The production of 36 target words is assessed by a blinded outcome data assessor at baseline, post-intervention, and 1-month follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. IQ is measured using Mullen Scales of Early Learning, 1995 at baseline, post-intervention, and 1-month follow-up. 2. Receptive and expressive language is measured using Receptive and Expressive One-Word Picture Vocabulary Tests, Fourth Edition; ROWPVT-4, EOWPVT-4 at baseline, post-intervention, and 1-month follow-up. 3. ASD symptomatology is measured using the ADOS-2 at baseline, post-intervention, and 1-month follow-up. 4. Vocal production throughout 3 days is measured using audio recordings at baseline, post-intervention, and 1-month follow-up. | — |
Countries
England, United Kingdom