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Pivotal Response Intervention Minimal Responders Study

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05511220
Acronym
PRIMeR
Enrollment
40
Registered
2022-08-22
Start date
2022-07-12
Completion date
2025-03-30
Last updated
2022-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder With Impaired Functional Language

Keywords

autism spectrum disorder, limited verbal ability, early intervention, parent-mediated intervention

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,

Interventions

BEHAVIORALPRIMeR

Virtual PRIMeR intervention consists of coaching parents to use strategies derived from Social Routines (to boost positive affect) and Reciprocal Imitation Training (to boost toy play)

BEHAVIORALPRT

Virtual PRT intervention consists of coaching parents to use key PRT strategies to enhance children's communication skills

Sponsors

Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
IWK Health Centre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Primary outcome will be coded by raters who are trained to 80% reliability on a coding scheme with operational definitions, and naive to treatment condition and study phase

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.

Eligibility

Sex/Gender
ALL
Age
3 Years to 5 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Social initiationsAssessed at baseline, entry to EI program, and after 6 months of EI programChange in frequency of child's social initiations toward parent, blind-coded from video sample

Secondary

MeasureTime frameDescription
CommunicationAssessed at baseline, entry to EI program, and after 6 months of EI programChange in level of communication derived from Assessment of Phase of Preschool Language (APPL)

Countries

Canada

Contacts

Primary ContactIsabel M Smith, PhD
isabel.smith@iwk.nshealth.ca902-470-7275

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026