Efficacy of the ASPEN Intervention Program in Low-Resource Communities

Autism Spectrum Disorder Clinical Trial

— ASPEN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04505488
• Other study ID #: 90IFST0004
• Status: Recruiting
• Phase: N/A
• Start date: July 7, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: May 2022
• Source: Texas State University, San Marcos
• Contact: Sandra B Vanegas, PhD
• Phone: 5122454579
• Email: svanegas[@]txstate.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder

Intervention

Behavioral:
• ASD Screening Parent ENgagement Intervention Program (ASPEN)
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.

Locations

Country	Name	City	State
United States	Texas State University	San Marcos	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Texas State University, San Marcos	National Institute on Disability, Independent Living, and Rehabilitation Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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