NCT04505488

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Jul 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Jul 2020May 2026

Study Start

First participant enrolled

July 7, 2020

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2020

Completed
23 days until next milestone

First Posted

Study publicly available on registry

August 10, 2020

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Expected
Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

5.6 years

First QC Date

July 18, 2020

Last Update Submit

January 25, 2026

Conditions

Autism Spectrum Disorder

Keywords

AutismParent-mediated interventionNaturalistic developmental behavioral interventionLow resource households

Outcome Measures

Primary Outcomes (6)

  • Adaptive Behavior

    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

    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

    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

    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

    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

    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 Outcomes (4)

  • Child Challenging Behavior

    Baseline to Post-Intervention (12-14 weeks post baseline) Change

  • Child Challenging Behavior

    Baseline to Follow-Up (24-28 weeks post baseline) Change

  • Family Quality of Life

    Baseline to Post-Intervention (12-14 weeks post baseline) Change

  • Family Quality of Life

    Baseline to Follow-Up (24-28 weeks post baseline) Change

Study Arms (2)

Intervention Group

EXPERIMENTAL

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)

Control Group

NO 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.

Interventions

ASD Screening Parent ENgagement Intervention Program (ASPEN)BEHAVIORAL

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.

Also known as: ASPEN
Intervention Group

Eligibility Criteria

Age18 Months - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78758, United States

Location

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Sandra B Vanegas, PhD

    University of Texas at Austin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

July 18, 2020

First Posted

August 10, 2020

Study Start

July 7, 2020

Primary Completion

February 28, 2026

Study Completion (Estimated)

May 31, 2026

Last Updated

January 27, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available 1 year after study completion.
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.

Locations

US(1)