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Behavioural Intervention

Pathways Intervention for Autism

N/A
Recruiting
Led By Pamela R Rollins, Ed.D
Research Sponsored by The University of Texas at Dallas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
are between 12-42 months old at the start of the study;
Caregivers and their children who are between 12-42 months old at the start of the study;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed for changes from baseline to 24 weeks and from 24-to-36 weeks
Awards & highlights

Study Summary

This trial tests if Pathways is better than PEI for helping autistic children develop social skills and reducing parental stress. Parents enrolled will receive one of two treatments and assessments of their child at intervals.

Who is the study for?
This trial is for families in Dallas, Texas with children aged 12-42 months who are diagnosed with or suspected of having autism. Participants must speak English or Spanish at home and have no other neurological or genetic disorders. The child's autism diagnosis needs to be confirmed by a specific test called ADOS-2.Check my eligibility
What is being tested?
The study compares two interventions: Pathways, which involves parents in early autism intervention, and PEI, focused on parent education. It aims to see if Pathways improves social attention and language skills more effectively than PEI and reduces parental stress over a 24-week period.See study design
What are the potential side effects?
Since this trial focuses on educational interventions rather than medications, traditional side effects are not applicable. However, there may be varying levels of stress or emotional impact associated with the intensity of the programs on both children and their parents.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My child is between 1 and 3.5 years old.
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I am a caregiver with a child aged 12-42 months.
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I do not have any known neurological or genetic disorders.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed for changes from baseline to 24 weeks and from 24-to-36 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed for changes from baseline to 24 weeks and from 24-to-36 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in child language
Change in child social communication
Changes in child Joint attention
+2 more
Secondary outcome measures
Changes in motor skills
Changes in parenting stress
changes in child adaptive functioning
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Pathways InterventionExperimental Treatment1 Intervention
Twenty-four weeks of a manualized Naturalistic Developmental Behavioral Intervention (NDBI) parent-mediated early autism intervention that uses a coaching model.
Group II: Parent Education Intervention (PEI)Active Control1 Intervention
Twenty-four weeks of individual caregiver training without the child being present.

Find a Location

Who is running the clinical trial?

The University of Texas at DallasLead Sponsor
58 Previous Clinical Trials
106,125 Total Patients Enrolled
Pamela R Rollins, Ed.DPrincipal InvestigatorUniversity of Texas at Dallas

Media Library

Pathways Intervention (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05604326 — N/A
Autism Research Study Groups: Parent Education Intervention (PEI), Pathways Intervention
Autism Clinical Trial 2023: Pathways Intervention Highlights & Side Effects. Trial Name: NCT05604326 — N/A
Pathways Intervention (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05604326 — N/A

Frequently Asked Questions

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

Are there still opportunities for patients to participate in this research?

"The data hosted on clinicaltrials.gov affirms that this investigation is still looking for potential participants. It was created on October 27th 2022 and updated lastly on November 11th 2022."

Answered by AI

What are the goals of this research endeavor?

"The primary goal of this clinical trial, tracked over 36 weeks with assessments conducted every 12 weeks, is to determine the impact on intentional communication. Additionally, changes in child adaptive functioning (as measured by Vineland II), cognitive skills (assessed via Bayley-4) and motor skills (also assessed via Bayley-4) will be monitored as secondary objectives."

Answered by AI

Is this clinical trial catering to geriatric individuals?

"As specified by the trial's eligibility criteria, individuals aged between 12 Months and 42 Months are able to participate. Out of 271 trials, 229 target minors while 42 focus on elderly patients."

Answered by AI

Who is able to take part in the current clinical experiment?

"Eligibility for this trial requires an autism spectrum disorder diagnosis and the patient to be between 12 months old and 42 months old. A total of 150 participants are needed to complete the study."

Answered by AI

What is the scope of patients included in this trial?

"Affirmative. According to clinicaltrials.gov, this medical trial is actively recruiting patients since its inception on October 27th 2022 and subsequent update on November 11th 2022. This specific investigation requires 150 participants at a single site."

Answered by AI

Who else is applying?

What state do they live in?
Texas
British Columbia
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
The University of Texas/Callier Center for Communication Disorders

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. The University of Texas/Callier Center for Communication Disorders: < 24 hours
Average response time
  • < 1 Day
~50 spots leftby Feb 2025