Efficacy of the ASPEN Intervention Program in Low-Resource Communities

The University of Texas System (UT)

Status: Active, not recruiting

Conditions: Autism Spectrum Disorder

Treatments: Behavioral: ASD Screening Parent ENgagement Intervention Program (ASPEN)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04505488

90IFST0004

Details and patient eligibility

About

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.

Enrollment: 320 estimated patients

Sex: All

Ages: 18 months to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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320 participants in 2 patient groups

Intervention Group

Experimental group

Description:

The intervention group will receive a parent manual, a resource packet, and 12 weekly sessions delivered by the clinician and peer leader.

Treatment:

Behavioral: ASD Screening Parent ENgagement Intervention Program (ASPEN)

Control Group

No Intervention group

Description:

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.