Clinical trial NCT05511220: Pivotal Response Intervention Minimal Responders Study
Official title: Amplifying Treatment Response in Early Intervention 'Minimal Responders' With Autism Spectrum Disorder: A Virtual Parent-Coaching Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autism Spectrum Disorder With Impaired Functional Language
Keywords: autism spectrum disorder
limited verbal ability
early intervention
parent-mediated intervention
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2022-08-22
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Hierarchical modelling will be used to examine aggregated data from multiple single case experimental design (SCED) series (n = 5 per series), with participants randomized to 1 of 2 treatment conditions. Target is 4 SCED series per treatment condition, therefore N of 20 per condition. See Jaksic et al. (2018) for information on this method.
Primary purpose: TREATMENT

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,

Eligibility criteria: Inclusion Criteria:

1. upcoming enrollment in NS EI program for preschoolers with autism spectrum disorder (ASD), based on confirmed or provisional ASD diagnosis by a qualified clinician
2. significant delay in cognitive abilities (assessed formally by psychologist or estimated by psychologist or developmental pediatrician at time of diagnosis)
3. current spontaneous functional use of ≤ 10 words (clinician's observations; parent report using MacArthur-Bates Communicative Development Inventory - Words \& Gestures (CDI-WG)
4. limited use of toys / objects (clinician's impression or parent's report with no contrary observation by clinician)
5. 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:

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

Primary outcomes:
measure: Social initiations
timeFrame: Assessed at baseline, entry to EI program, and after 6 months of EI program
Secondary outcomes:
measure: Communication
timeFrame: Assessed at baseline, entry to EI program, and after 6 months of EI program
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
Study officials:
affiliation: IWK Health Centre and Dalhousie University
name: Isabel M Smith, PhD
role: PRINCIPAL_INVESTIGATOR
References: