Efficacy of the ASPEN Intervention Program in Low-Resource Communities

Study Overview
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Brief Summary
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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.

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

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Behavioral: ASD Screening Parent ENgagement Intervention Program (ASPEN)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>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)<br>* 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.<br>* Other names: ASPEN;|
| No Intervention: Control Group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child Challenging Behavior | Scales of Independent Behavior-Revised: Problem Behavior Subscale Minimum value = +10; Maximum value = -74; Higher scores indicate a better outcome | Baseline to Post-Intervention (12-14 weeks post baseline) Change | 
| Child Challenging Behavior | Minimum value = +10; Maximum value = -74; Higher scores indicate a better outcome | Baseline to Follow-Up (24-28 weeks post baseline) Change | 
| Family Quality of Life | PedsQL Family Impact Module: Family Functioning Minimum value = 0; Maximum value = 100; Higher scores indicate a better outcome | Baseline to Post-Intervention (12-14 weeks post baseline) Change | 
| Family Quality of Life | PedsQL Family Impact Module: Family Functioning Minimum value = 0; Maximum value = 100; Higher scores indicate a better outcome | Baseline to Follow-Up (24-28 weeks post baseline) Change | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autism, Parent-mediated intervention, Naturalistic developmental behavioral intervention, Low resource households