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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 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

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

Do I qualify?Apply below to find out

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

1,344 Previous Clinical Trials

26,453,377 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial cater to individuals whose age surpasses eighty-five years?

"The participation requirements for this research indicate that the minimum age is 3 and the maximum age to be considered eligible is 5."

Answered by AI

What is the upper limit on participants in this research project?

"Affirmative. According to clinicaltrials.gov, the study which was initially posted on July 12th 2022 is currently seeking patients. The team needs 40 individuals at a single site to complete the trial."

Answered by AI

Is there the possibility of me joining this experimental protocol?

"This medical trial is recruiting forty children with an Autism Spectrum Disorder (ASD) and impaired functional language, aged between three and five years old. Applicants must have a confirmed or provisional diagnosis of ASD from a certified clinician, be enrolled in the NS EI program for pre-schoolers with autism spectrum disorder, possess fewer than ten words that are used spontaneously according to parent report via the MacArthur-Bates Communicative Development Inventory - Words & Gestures (CDI-WG), display limited positive affect or high levels of negative affect based on both parental reports and clinician assessments, show cognitive delay either formally assessed by a psychologist"

Answered by AI

Is it currently feasible to join this research study?

"Affirmative, clinicaltrials.gov shows that this research is actively recruiting participants. The trial first appeared on July 12th 2022 and was revised most recently on August 19th 2022. This study has a goal to include 40 individuals from 1 medical centre in the experiment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pivotal Response Intervention Minimal Responders Study

Dr. Isabel Smith 2022. "Pivotal Response Intervention Minimal Responders Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05511220.