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Clinical Trials/NCT05511220
NCT05511220
Recruiting
N/A

Amplifying Treatment Response in Early Intervention 'Minimal Responders' With Autism Spectrum Disorder: A Virtual Parent-Coaching Intervention

IWK Health Centre1 site in 1 country40 target enrollmentJuly 12, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Autism Spectrum Disorder With Impaired Functional Language
Sponsor
IWK Health Centre
Enrollment
40
Locations
1
Primary Endpoint
Social initiations
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

Early intervention (EI) using naturalistic behavioural methods have shown benefits for the development of communication and other skills for young children with autism spectrum disorder. The publicly funded autism EI program in Nova Scotia (NS) is based on such a method, Pivotal Response Treatment (PRT), and pre-post studies indicate benefits for children and families. However, not all children benefit equally. In this study, the investigators test the efficacy of a brief parent-mediated intervention designed to prime responsivity to PRT in children with a minimal responder profile derived from previous studies of the PRT-based EI program.

Detailed Description

Investigators will enroll preschoolers with the minimal responder profile who are scheduled to begin the PRT-based public EI program. Consenting parents will be offered a virtual intervention in which they will be randomized to 1 of 2 arms to receive coaching in either (a) PRIMeR intervention, designed to target areas of weakness in the minimal responder profile, or (b) PRT, the treatment model used in the EI program. Coaching will take place on a virtual (video-conferencing) platform. Each child's progress on treatment targets will be assessed in a single case experimental design (SCED) using data from blind-coded video-recordings of parent-child play episodes using a standard set of toys. Overall study effects will be based on aggregated data for an anticipated n of 20 participants assigned to each arm (4 SCED series with 5 participants each contributing to each arm). The primary outcome is gains in children's social initiations (video-coded); the secondary outcome is gains in children's communication levels (multi-method assessment). Mixed methods will be used to evaluate aspects of parents' experiences,

Registry
clinicaltrials.gov
Start Date
July 12, 2022
End Date
March 30, 2025
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Isabel Smith

Professor; Joan & Jack Craig Chair in Autism Research

IWK Health Centre

Eligibility Criteria

Inclusion Criteria

  • upcoming enrollment in NS EI program for preschoolers with autism spectrum disorder (ASD), based on confirmed or provisional ASD diagnosis by a qualified clinician
  • significant delay in cognitive abilities (assessed formally by psychologist or estimated by psychologist or developmental pediatrician at time of diagnosis)
  • current spontaneous functional use of ≤ 10 words (clinician's observations; parent report using MacArthur-Bates Communicative Development Inventory - Words \& Gestures (CDI-WG)
  • limited use of toys / objects (clinician's impression or parent's report with no contrary observation by clinician)
  • low levels of expressed positive affect (smiles, laughter) or limited positive and high negative affect (clinician's impression or parent's report with no contrary observation by clinician)

Exclusion Criteria

  • Severe sensory or motor impairment in child
  • Parent unable to complete consent process (and receive coaching) in English

Outcomes

Primary Outcomes

Social initiations

Time Frame: Assessed at baseline, entry to EI program, and after 6 months of EI program

Change in frequency of child's social initiations toward parent, blind-coded from video sample

Secondary Outcomes

  • Communication(Assessed at baseline, entry to EI program, and after 6 months of EI program)

Study Sites (1)

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