Pivotal Response Intervention Minimal Responders Study

NCT05511220 | Unknown

• 1 other identifier: 1027196
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Social initiations

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

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

Secondary Outcomes (1)

• Communication

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

Study Arms (2)

PRIMeR

EXPERIMENTAL

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

Behavioral: PRIMeR

PRT

ACTIVE COMPARATOR

Virtual parent coaching in use of Pivotal Response Treatment strategies

Behavioral: PRT

Interventions

PRIMeR BEHAVIORAL

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)

Also known as: Social Routines, Reciprocal Imitation Training

PRIMeR

PRT BEHAVIORAL

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

Also known as: Pivotal Response Treatment

PRT

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• IWK Health Centre: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

DNA Primers

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Oligodeoxyribonucleotides; Oligonucleotides; Polynucleotides; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; DNA Probes; Nucleic Acid Probes; Molecular Probes; Laboratory Chemicals; Specialty Uses of Chemicals; Chemical Actions and Uses

Study Officials

• Isabel M Smith, PhD

  IWK Health Centre and Dalhousie University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabel M Smith, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor; Joan & Jack Craig Chair in Autism Research

Model Details: 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.

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: August 22, 2022
• Study Start: July 12, 2022
• Primary Completion: October 1, 2024
• Study Completion: March 30, 2025
• Last Updated: August 22, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)