Recruiting

Pivotal Response Intervention

Sponsor:

IWK Health Centre

Code:

NCT05511220

Conditions

Autism Spectrum Disorder With Impaired Functional Language

Eligibility Criteria

Sex: All

Age: 3 - 5

Healthy Volunteers: Not accepted

Interventions

PRIMeR

PRT

Study Details

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.

Conditions

Autism Spectrum Disorder With Impaired Functional Language

Study ID

NCT05511220

Start date

Jul 12, 2022

Status verified date

Aug, 2022

Completion date

Mar 30, 2025

Anticipated

Primary completion date

Oct, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 5

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PRIMeR

Virtual parent coaching in use of a novel intervention consisting of Social Routines and Reciprocal Imitation Training strategies

active comparator: PRT

Virtual parent coaching in use of Pivotal Response Treatment strategies

Interventions

PRIMeR

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)

PRT

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

Primary outcome measure

  • Social initiations [ Time Frame: Assessed at baseline, entry to EI program, and after 6 months of EI program ]

Central Contacts and Locations

Central contacts

Isabel M Smith, PhD

902-470-7275isabel.smith@iwk.nshealth.ca

Locations

IWK Health Centre

Recruiting

Halifax, Nova Scotia, Canada, B3K 6R8

Contacts

Isabel M Smith, PhD

902-470-7275isabel.smith@iwk.nshealth.ca

Kathryne MacLeod, BSc

902-470-7275kathryne.macleod@iwk.nshealth.ca

More Information

Sponsor

IWK Health Centre

Last update posted

Aug 22, 2022

Last verified

Aug, 2022

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by IWK Health Centre on 2022-08-22.