What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for Autism Spectrum Disorder (ASD) include behavioral interventions like Pivotal Response Treatment (PRT) and parent-mediated interventions. These treatments generally have minimal side effects, primarily involving the time and effort required from parents and caregivers. However, some complementary and alternative therapies, such as omega-3 fatty acid supplementation, may cause gastrointestinal distress (e.g., nausea, diarrhea). It is important to avoid unproven and potentially risky treatments like chelation, hyperbaric oxygen, and certain dietary restrictions, which can lead to nutritional deficiencies and other health issues.

What prior FDA approvals exist?

The FDA has approved risperidone and aripiprazole for the treatment of irritability associated with Autism Spectrum Disorder (ASD). While behavioral interventions such as Pivotal Response Treatment (PRT) and parent-mediated approaches are commonly used and recommended for improving communication and social skills in children with ASD, they are not specifically FDA-approved treatments.

What other types of research exist?

Promising, novel alternatives to Brief Parent-Mediated Intervention (Priming Responsiveness to Pivotal Response Treatment) for Autism Spectrum Disorder patients include: 1. Focused Playtime Intervention (FPI), which has shown significant increases in responsive parental communication and attachment behaviors in children with ASD. 2. Contextual Intervention adapted for Autism Spectrum Disorders (CI-ASD), which promotes children's participation and enhances mothers' parenting self-efficacy. Both interventions have demonstrated efficacy in recent randomized clinical trials.

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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

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed at baseline, entry to ei program, and after 6 months of ei program

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

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

Do I qualify?Apply below to find out

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

100,746 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

26,460,479 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

~3 spots leftby Oct 2024

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