Clinical trial NCT04505488: Efficacy of the ASPEN Intervention Program in Low-Resource Communities
Official title: Efficacy of the ASD Screening and Parent ENgagement (ASPEN) Intervention Program in Low-Resource Communities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Autism
Parent-mediated intervention
Naturalistic developmental behavioral intervention
Low resource households
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: National Institute on Disability, Independent Living, and Rehabilitation Research
First posted: 2020-08-10
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Adaptive Behavior
timeFrame: Baseline to Post-Intervention (12-14 weeks post baseline) Change
measure: Adaptive Behavior
timeFrame: Baseline to Follow-Up (24-28 weeks post baseline) Change
measure: Parenting Stress
timeFrame: Baseline to Post-Intervention (12-14 weeks post baseline) Change
measure: Parenting Stress
timeFrame: Baseline to Follow-Up (24-28 weeks post baseline) Change
measure: Parent Empowerment
timeFrame: Baseline to Post-Intervention (12-14 weeks post baseline) Change
measure: Parent Empowerment
timeFrame: Baseline to Follow-Up (24-28 weeks post baseline) Change
Secondary outcomes:
measure: Child Challenging Behavior
timeFrame: Baseline to Post-Intervention (12-14 weeks post baseline) Change
measure: Child Challenging Behavior
timeFrame: Baseline to Follow-Up (24-28 weeks post baseline) Change
measure: Family Quality of Life
timeFrame: Baseline to Post-Intervention (12-14 weeks post baseline) Change
measure: Family Quality of Life
timeFrame: Baseline to Follow-Up (24-28 weeks post baseline) Change
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas at Austin
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Sandra B Vanegas, PhD
role: PRINCIPAL_INVESTIGATOR
References: