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Pivotal Response Intervention Minimal Responders Study (PRIMeR)

Primary Purpose

Autism Spectrum Disorder With Impaired Functional Language

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
PRIMeR
PRT
Sponsored by
IWK Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder With Impaired Functional Language focused on measuring autism spectrum disorder, limited verbal ability, early intervention, parent-mediated intervention

Eligibility Criteria

3 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • IWK Health CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PRIMeR

PRT

Arm Description

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

Virtual parent coaching in use of Pivotal Response Treatment strategies

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Communication
Change in level of communication derived from Assessment of Phase of Preschool Language (APPL)

Full Information

First Posted
August 5, 2022
Last Updated
August 19, 2022
Sponsor
IWK Health Centre
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT05511220
Brief Title
Pivotal Response Intervention Minimal Responders Study
Acronym
PRIMeR
Official Title
Amplifying Treatment Response in Early Intervention 'Minimal Responders' With Autism Spectrum Disorder: A Virtual Parent-Coaching Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 12, 2022 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
March 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IWK Health Centre
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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,

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder With Impaired Functional Language
Keywords
autism spectrum disorder, limited verbal ability, early intervention, parent-mediated intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
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
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PRIMeR
Arm Type
Experimental
Arm Description
Virtual parent coaching in use of a novel intervention consisting of Social Routines and Reciprocal Imitation Training strategies
Arm Title
PRT
Arm Type
Active Comparator
Arm Description
Virtual parent coaching in use of Pivotal Response Treatment strategies
Intervention Type
Behavioral
Intervention Name(s)
PRIMeR
Other Intervention Name(s)
Social Routines, Reciprocal Imitation Training
Intervention Description
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)
Intervention Type
Behavioral
Intervention Name(s)
PRT
Other Intervention Name(s)
Pivotal Response Treatment
Intervention Description
Virtual PRT intervention consists of coaching parents to use key PRT strategies to enhance children's communication skills
Primary Outcome Measure Information:
Title
Social initiations
Description
Change in frequency of child's social initiations toward parent, blind-coded from video sample
Time Frame
Assessed at baseline, entry to EI program, and after 6 months of EI program
Secondary Outcome Measure Information:
Title
Communication
Description
Change in level of communication derived from Assessment of Phase of Preschool Language (APPL)
Time Frame
Assessed at baseline, entry to EI program, and after 6 months of EI program

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: Severe sensory or motor impairment in child Parent unable to complete consent process (and receive coaching) in English
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Isabel M Smith, PhD
Phone
902-470-7275
Email
isabel.smith@iwk.nshealth.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabel M Smith, PhD
Organizational Affiliation
IWK Health Centre and Dalhousie University
Official's Role
Principal Investigator
Facility Information:
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabel M Smith, PhD
Phone
902-470-7275
Email
isabel.smith@iwk.nshealth.ca
First Name & Middle Initial & Last Name & Degree
Kathryne MacLeod, BSc
Phone
902-470-7275
Email
kathryne.macleod@iwk.nshealth.ca

12. IPD Sharing Statement

Plan to Share IPD
No

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Pivotal Response Intervention Minimal Responders Study

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