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ASPEN Program for Autism (ASPEN Trial)

N/A
Recruiting
Led By Sandra B Vanegas, PhD
Research Sponsored by University of Texas at Austin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Child is between 18 months through 6 years of age
-Child or family has Medicaid as an insurance provider
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to follow-up (24-28 weeks post baseline) change
Awards & highlights
No Placebo-Only Group

Summary

"This trial is testing a program called ASPEN which helps parents of young children with developmental delays to address social communication and behavioral difficulties. The program consists of 12 sessions where parents are taught about self-care

Who is the study for?
This trial is for primary caregivers of children aged 18 months to 6 years who have or are at risk for Autism/ASD, based on specific assessments. Caregivers should have a high school education or less, live in low-income households (200% below the Federal Poverty Level), and have Medicaid.
What is being tested?
The ASPEN program aims to improve social communication and behavior in young children with developmental delays through parent-mediated intervention. It includes psychoeducation, evidence-based strategies coaching, and support over 12 sessions by student clinicians and peer leaders.
What are the potential side effects?
Since this is an educational and supportive intervention rather than a medical treatment, there are no direct physical side effects expected from participating in the ASPEN program.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My child is between 18 months and 6 years old.
Select...
My family or I am covered by Medicaid.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to follow-up (24-28 weeks post baseline) change
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to follow-up (24-28 weeks post baseline) change for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adaptive Behavior
Parent Empowerment
Parenting Stress
Secondary study objectives
Child Challenging Behavior
Family Quality of Life

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention GroupExperimental Treatment1 Intervention
The intervention group will receive a parent manual, a resource packet, and 12 weekly sessions delivered by the clinician and peer leader.
Group II: Control GroupActive Control1 Intervention
The control group will receive a parent manual and a resource packet. Four phone check-ins will be conducted across 12-14 weeks to address questions by the research team.

Find a Location

Who is running the clinical trial?

University of Texas at AustinLead Sponsor
372 Previous Clinical Trials
83,719 Total Patients Enrolled
4 Trials studying Autism Spectrum Disorder
475 Patients Enrolled for Autism Spectrum Disorder
Texas State University, San MarcosLead Sponsor
4 Previous Clinical Trials
163 Total Patients Enrolled
National Institute on Disability, Independent Living, and Rehabilitation ResearchFED
79 Previous Clinical Trials
9,527 Total Patients Enrolled
1 Trials studying Autism Spectrum Disorder
162 Patients Enrolled for Autism Spectrum Disorder
~61 spots leftby Oct 2025
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