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Efficacy of the ASPEN Intervention Program in Low-Resource Communities

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04505488
Acronym
ASPEN
Enrollment
180
Registered
2020-08-10
Start date
2020-02-11
Completion date
2026-05-31
Last updated
2026-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Keywords

Autism, Parent-mediated intervention, Naturalistic developmental behavioral intervention, Low resource households

Brief summary

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.

Interventions

BEHAVIORALASD 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.

Sponsors

University of Texas at Austin
Lead SponsorOTHER
National Institute on Disability, Independent Living, and Rehabilitation Research
CollaboratorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Months to 6 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Adaptive BehaviorBaseline to Post-Intervention (12-14 weeks post baseline) ChangeVineland Adaptive Behavior Scales - 3: Adaptive Behavior Composite Standard Score Minimum value = 20; Maximum value = 140; Higher scores indicate a better outcome
Parenting StressBaseline to Post-Intervention (12-14 weeks post baseline) ChangeParenting Stress Index - Short Form Total Stress T Score Minimum value = 32; Maximum value = 92; Higher scores indicate a worse outcome
Parent EmpowermentBaseline to Post-Intervention (12-14 weeks post baseline) ChangeFamily Outcomes Scales - Revised Minimum value = 1; Maximum value = 5; Higher scores indicate a better outcome

Secondary

MeasureTime frameDescription
Child Challenging BehaviorBaseline to Post-Intervention (12-14 weeks post baseline) ChangeScales of Independent Behavior-Revised: Problem Behavior Subscale Minimum value = +10; Maximum value = -74; Higher scores indicate a better outcome
Family Quality of LifeBaseline to Post-Intervention (12-14 weeks post baseline) ChangePedsQL Family Impact Module: Family Functioning Minimum value = 0; Maximum value = 100; Higher scores indicate a better outcome

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORSandra B Vanegas, PhD

University of Texas at Austin

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 20, 2026