Efficacy of the ASPEN Intervention Program in Low-Resource Communities (ASPEN)

June 5, 2026 updated by: Sandra B. Vanegas, University of Texas at Austin

Efficacy of the ASD Screening and Parent ENgagement (ASPEN) Intervention Program in Low-Resource Communities

The ASD Screening and Parent ENgagement (ASPEN) program is a culturally adapted, parent-mediated intervention program. The ASPEN program is tailored to address social communication and behavioral difficulties that young children with developmental delays may experience in early childhood. The ASPEN Program includes 12 sessions where parents are provided with psychoeducation about self-care, child development, and evidence-based strategies. Coaching is also provided to train parents on using evidence-based strategies within the home setting. The ASPEN program is delivered by a student clinician and a peer leader. We hypothesize that coaching strategies delivered by the clinician will lead to primary family caregivers learning evidence-based strategies and this will result in improved child outcomes. We hypothesize that education and family support delivered by peer leaders will help primary family caregivers learn social support strategies and this will lead to improved parent outcomes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78758
        • University of Texas at Austin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year to 6 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Child is between 18 months through 6 years of age
  • Child has a medical diagnosis or educational classification of Autism or Autism Spectrum Disorder (ASD) or child is at-risk for Autism/ASD as determined by the Modified-Checklist for Autism in Toddlers - Revised/Follow-up Interview (M-CHAT-R/F) and/or Social Communication Questionnaire (SCQ)
  • Child resides in a low-resource household as determined by at least one of the following criteria:
  • -Child or family has Medicaid as an insurance provider
  • -Child's primary caregiver has achieved a high school or lower education
  • -Child resides in a household with an annual income of 200% of the Federal Poverty Level

Exclusion Criteria:

  • Primary caregiver does not speak/understand English or Spanish
  • Child is younger 18 months or older than 6 years of age
  • Child does not have a medical diagnosis or educational classification of Autism/ASD or does not meet at-risk criteria on the M-CHAT-R/F and/or SCQ
  • Child does not reside in low-resource household

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention Group
The intervention group will receive a parent manual, a resource packet, and 12 weekly sessions delivered by the clinician and peer leader.
Behavioral: ASD Screening Parent ENgagement Intervention Program (ASPEN)
The ASPEN intervention is based on naturalistic developmental behavioral intervention strategies to support the development of social communication and play skills and reduce challenging behavior.
Other Names:
  • ASPEN
No Intervention: Control Group
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adaptive Behavior
Time Frame: Baseline to Post-Intervention (12-14 weeks post baseline) Change
Vineland Adaptive Behavior Scales - 3: Adaptive Behavior Composite Standard Score Minimum value = 20; Maximum value = 140; Higher scores indicate a better outcome
Baseline to Post-Intervention (12-14 weeks post baseline) Change
Adaptive Behavior
Time Frame: Baseline to Follow-Up (24-28 weeks post baseline) Change
Vineland Adaptive Behavior Scales - 3: Adaptive Behavior Composite Standard Score Minimum value = 20; Maximum value = 140; Higher scores indicate a better outcome
Baseline to Follow-Up (24-28 weeks post baseline) Change
Parenting Stress
Time Frame: Baseline to Post-Intervention (12-14 weeks post baseline) Change
Parenting Stress Index - Short Form Total Stress T Score Minimum value = 32; Maximum value = 92; Higher scores indicate a worse outcome
Baseline to Post-Intervention (12-14 weeks post baseline) Change
Parenting Stress
Time Frame: Baseline to Follow-Up (24-28 weeks post baseline) Change
Parenting Stress Index - Short Form Total Stress T Score Minimum value = 32; Maximum value = 92; Higher scores indicate a worse outcome
Baseline to Follow-Up (24-28 weeks post baseline) Change
Parent Empowerment
Time Frame: Baseline to Post-Intervention (12-14 weeks post baseline) Change
Family Outcomes Scales - Revised Minimum value = 1; Maximum value = 5; Higher scores indicate a better outcome
Baseline to Post-Intervention (12-14 weeks post baseline) Change
Parent Empowerment
Time Frame: Baseline to Follow-Up (24-28 weeks post baseline) Change
Family Outcomes Scales - Revised Minimum value = 1; Maximum value = 5; Higher scores indicate a better outcome
Baseline to Follow-Up (24-28 weeks post baseline) Change

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Child Challenging Behavior
Time Frame: Baseline to Post-Intervention (12-14 weeks post baseline) Change
Scales of Independent Behavior-Revised: Problem Behavior Subscale Minimum value = +10; Maximum value = -74; Higher scores indicate a better outcome
Baseline to Post-Intervention (12-14 weeks post baseline) Change
Child Challenging Behavior
Time Frame: Baseline to Follow-Up (24-28 weeks post baseline) Change
Minimum value = +10; Maximum value = -74; Higher scores indicate a better outcome
Baseline to Follow-Up (24-28 weeks post baseline) Change
Family Quality of Life
Time Frame: Baseline to Post-Intervention (12-14 weeks post baseline) Change
PedsQL Family Impact Module: Family Functioning Minimum value = 0; Maximum value = 100; Higher scores indicate a better outcome
Baseline to Post-Intervention (12-14 weeks post baseline) Change
Family Quality of Life
Time Frame: Baseline to Follow-Up (24-28 weeks post baseline) Change
PedsQL Family Impact Module: Family Functioning Minimum value = 0; Maximum value = 100; Higher scores indicate a better outcome
Baseline to Follow-Up (24-28 weeks post baseline) Change

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Texas at Austin

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Disability, Independent Living, and Rehabilitation Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sandra B Vanegas, PhD, University of Texas at Austin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 11, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 5, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 18, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 10, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 90IFST0004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

Data will be available 1 year after study completion.

IPD Sharing Access Criteria

Electronic data from assessments will be submitted to Inter-university Consortium for Political and Social Research within 1 year after study completion for archival and storage purposes.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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