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Parent-Mediated Intervention for Autism Spectrum Disorder (PRIMeR Trial)

N/A
Recruiting
Led By Isabel M Smith, PhD
Research Sponsored by IWK Health Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at baseline, entry to ei program, and after 6 months of ei program
Awards & highlights

PRIMeR Trial Summary

This trial tests the efficacy of a brief parent-mediated intervention to improve communication skills in children with autism spectrum disorder who have not responded well to other methods.

Who is the study for?
This trial is for preschoolers with autism spectrum disorder in Nova Scotia who show minimal response to standard treatments. They should have limited positive emotions, use fewer than 10 words spontaneously, and be about to enroll in the NS EI program. Children with severe sensory or motor impairments or whose parents can't consent in English are excluded.Check my eligibility
What is being tested?
The study tests a brief parent-led intervention called PRIMeR aimed at increasing children's responsiveness to Pivotal Response Treatment (PRT), an existing method used by the publicly funded autism early intervention program in Nova Scotia.See study design
What are the potential side effects?
Since this trial involves behavioral interventions rather than medication, traditional side effects are not expected. However, there may be variations in individual responses to therapy sessions.

PRIMeR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at baseline, entry to ei program, and after 6 months of ei program
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at baseline, entry to ei program, and after 6 months of ei program for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Social initiations
Secondary outcome measures
Communication

PRIMeR Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PRIMeRExperimental Treatment1 Intervention
Virtual parent coaching in use of a novel intervention consisting of Social Routines and Reciprocal Imitation Training strategies
Group II: PRTActive Control1 Intervention
Virtual parent coaching in use of Pivotal Response Treatment strategies

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Autism Spectrum Disorder (ASD) often involve behavioral and educational interventions such as Applied Behavior Analysis (ABA) and naturalistic developmental behavioral interventions (NDBIs) like Pivotal Response Treatment (PRT). These methods work by reinforcing desired behaviors and improving social communication and adaptive skills through structured and naturalistic settings. Parent-mediated interventions, where caregivers are trained to apply these strategies, are particularly effective as they provide consistent reinforcement in the child's daily environment. Understanding these mechanisms is crucial for ASD patients as it allows for personalized interventions that can significantly enhance developmental outcomes and quality of life.
Research-Based Intervention (RBI) for Autism Spectrum Disorder: Looking beyond Traditional Models and Outcome Measures for Clinical Trials.Pharmacological and dietary-supplement treatments for autism spectrum disorder: a systematic review and network meta-analysis.What are we targeting when we treat autism spectrum disorder? A systematic review of 406 clinical trials.

Find a Location

Who is running the clinical trial?

IWK Health CentreLead Sponsor
125 Previous Clinical Trials
100,433 Total Patients Enrolled
4 Trials studying Autism Spectrum Disorder
883 Patients Enrolled for Autism Spectrum Disorder
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,354 Previous Clinical Trials
26,460,166 Total Patients Enrolled
4 Trials studying Autism Spectrum Disorder
592 Patients Enrolled for Autism Spectrum Disorder
Isabel M Smith, PhDPrincipal InvestigatorIWK Health Centre and Dalhousie University

Media Library

PRIMeR Clinical Trial Eligibility Overview. Trial Name: NCT05511220 — N/A
Autism Spectrum Disorder Research Study Groups: PRIMeR, PRT
Autism Spectrum Disorder Clinical Trial 2023: PRIMeR Highlights & Side Effects. Trial Name: NCT05511220 — N/A
PRIMeR 2023 Treatment Timeline for Medical Study. Trial Name: NCT05511220 — N/A
~5 spots leftby Oct 2024