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Completed

NCT Number: NCT04505488

Efficacy of the 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.

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Key information

Conditions

Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

18 month–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas at Austin

Austin, Texas, 78758, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: ASPEN

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Collaborators

  • National Institute on Disability, Independent Living, and Rehabilitation Research

Registry information

Official study title

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

Acronym: ASPEN

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Aug 10, 2020
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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