A randomised-controlled trial of low-intensity Early Start Denver Model therapy and parent coaching for young children with autism.

Not Applicable

Completed

• Conditions: autism spectrum disorder; Mental Health - Autistic spectrum disorders

• Registration Number: ACTRN12621000043831
• Lead Sponsor: Dr Hannah Waddington

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-18
• Study Completion: 2023-08-14
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Children and families will be eligible for this trial if: (a) the child is between the ages of 1 and 5 years at the start of the study; (b) the child has an official diagnosis of ASD, or the child is highly likely to be diagnosed with ASD because they meet the criteria for ASD diagnosis based on a clinician-administered ADOS-2 assessment; (c) the primary caregiver involved in the trial speaks sufficient English to understand the requirements of the study and to be able to participate fully in the coaching sessions; (d) the child does not have another serious medical, genetic, neurological or sensory condition (e.g., Down syndrome, fragile X); (e) the child is not receiving 15 or more hours per week of professionally implemented early intervention; and (f) the family does not intend to move out of the Wellington region during the 6 month pre-and post-assessment period.

Exclusion Criteria

None

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Child engagement measured using an adapted version of Bakeman and Adamson's (1984) engagement measure.[ At baseline, and six months after randomisation]

Secondary Outcome Measures

Name	Time	Method
Child Language (total words and number of different words)- during both the Eliciting Language Samples for Analysis – Toddler (ELSA-T) and naturalistic interactions with parents. [ At baseline, and six months after randomisation];Child developmental functioning- Mullen Scales of Early Learning (MSEL)[ At baseline, and six months after randomisation];Child adaptive behaviour (Communication, Socialisation, and Daily Living skills)- Vineland Adaptive Behaviour Scales – 3rd edition (VABS-III) <br>[ At baseline, and six months after randomisation];Parent use of ESDM techniques using the ESDM fidelity checklist[ At baseline, and six months after randomisation];Parent stress- Autism parent stress index (APSI) [ At baseline, and six months after randomisation];Family quality of life questionnaire (FQOL)[ At baseline, and six months after randomisation];Parent sense of competence questionnaire [ At baseline, and six months after randomisation]