Efficacy of the ASD Screening and Parent ENgagement (ASPEN) Intervention Program in Low-Resource Communities
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Parenting Stress
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Months to 6 Years (Child)
- Sex
- All
- Accepts 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
Arms & Interventions
Control Group
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.
Intervention Group
The intervention group will receive a parent manual, a resource packet, and 12 weekly sessions delivered by the clinician and peer leader.
Intervention: ASD Screening Parent ENgagement Intervention Program (ASPEN) (Behavioral)
Outcomes
Primary Outcomes
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
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
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
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
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
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
Secondary Outcomes
- Child Challenging Behavior(Baseline to Follow-Up (24-28 weeks post baseline) Change)
- Family Quality of Life(Baseline to Follow-Up (24-28 weeks post baseline) Change)
- Child Challenging Behavior(Baseline to Post-Intervention (12-14 weeks post baseline) Change)
- Family Quality of Life(Baseline to Post-Intervention (12-14 weeks post baseline) Change)
Investigators
Sandra B. Vanegas
Research Assistant Professor
University of Texas at Austin