PRIMeR: Pivotal Response Intervention Minimal Responders Study

Sponsor

IWK Health Centre (Other)

Overall Status

Recruiting

CT.gov ID

NCT05511220

Collaborator

Canadian Institutes of Health Research (CIHR) (Other)

Enrollment

Location

Arms

32.6

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Autism Spectrum Disorder With Impaired Functional Language	Behavioral: PRIMeR Behavioral: PRT	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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:

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

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 12, 2022

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Mar 30, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Social initiations [Assessed at baseline, entry to EI program, and after 6 months of EI program]
Change in frequency of child's social initiations toward parent, blind-coded from video sample

Secondary Outcome Measures

Communication [Assessed at baseline, entry to EI program, and after 6 months of EI program]
Change in level of communication derived from Assessment of Phase of Preschool Language (APPL)

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 5 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)