Pivotal Response Intervention Minimal Responders Study (PRIMeR)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder With Impaired Functional Language
• Intervention / Treatment: Behavioral: PRIMeR; Behavioral: PRT

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,

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Isabel M Smith, PhD; Phone Number: 902-470-7275; Email: isabel.smith@iwk.nshealth.ca

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3K 6R8
      • Recruiting
      • IWK Health Centre
      • Contact: Isabel M Smith, PhD; Phone Number: 902-470-7275; Email: isabel.smith@iwk.nshealth.ca
      • Contact: Kathryne MacLeod, BSc; Phone Number: 902-470-7275; Email: kathryne.macleod@iwk.nshealth.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRIMeR; Virtual parent coaching in use of a novel intervention consisting of Social Routines and Reciprocal Imitation Training strategies	Behavioral: 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); Other Names: Social Routines; Reciprocal Imitation Training
Active Comparator: PRT; Virtual parent coaching in use of Pivotal Response Treatment strategies	Behavioral: PRT; Virtual PRT intervention consists of coaching parents to use key PRT strategies to enhance children's communication skills; Other Names: Pivotal Response Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Communication	Change in level of communication derived from Assessment of Phase of Preschool Language (APPL)	Assessed at baseline, entry to EI program, and after 6 months of EI program

Collaborators and Investigators

• Sponsor: IWK Health Centre
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Isabel M Smith, PhD, IWK Health Centre and Dalhousie University

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2022
• Primary Completion (Anticipated): October 1, 2024
• Study Completion (Anticipated): March 30, 2025

Study Registration Dates

• First Submitted: August 5, 2022
• First Submitted That Met QC Criteria: August 19, 2022
• First Posted (Actual): August 22, 2022

Study Record Updates

• Last Update Posted (Actual): August 22, 2022
• Last Update Submitted That Met QC Criteria: August 19, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: autism spectrum disorder; early intervention; limited verbal ability; parent-mediated intervention
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
• Other Study ID Numbers: 1027196

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No