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Efficacy of the ASPEN Intervention Program in Low-Resource Communities (ASPEN)

Primary Purpose

Autism Spectrum Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ASD Screening Parent ENgagement Intervention Program (ASPEN)
Sponsored by
Texas State University, San Marcos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Autism, Parent-mediated intervention, Naturalistic developmental behavioral intervention, Low resource households

Eligibility Criteria

18 Months - 6 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Texas State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Adaptive Behavior
Vineland Adaptive Behavior Scales - 3: Adaptive Behavior Composite Standard Score Minimum value = 20; Maximum value = 140; Higher scores indicate a better outcome
Adaptive Behavior
Vineland Adaptive Behavior Scales - 3: Adaptive Behavior Composite Standard Score Minimum value = 20; Maximum value = 140; Higher scores indicate a better outcome
Parenting Stress
Parenting Stress Index - Short Form Total Stress T Score Minimum value = 32; Maximum value = 92; Higher scores indicate a worse outcome
Parenting Stress
Parenting Stress Index - Short Form Total Stress T Score Minimum value = 32; Maximum value = 92; Higher scores indicate a worse outcome
Parent Empowerment
Family Outcomes Scales - Revised Minimum value = 1; Maximum value = 5; Higher scores indicate a better outcome
Parent Empowerment
Family Outcomes Scales - Revised Minimum value = 1; Maximum value = 5; Higher scores indicate a better outcome

Secondary Outcome Measures

Child Challenging Behavior
Scales of Independent Behavior-Revised: Problem Behavior Subscale Minimum value = +10; Maximum value = -74; Higher scores indicate a better outcome
Child Challenging Behavior
Minimum value = +10; Maximum value = -74; Higher scores indicate a better outcome
Family Quality of Life
PedsQL Family Impact Module: Family Functioning Minimum value = 0; Maximum value = 100; Higher scores indicate a better outcome
Family Quality of Life
PedsQL Family Impact Module: Family Functioning Minimum value = 0; Maximum value = 100; Higher scores indicate a better outcome

Full Information

First Posted
July 18, 2020
Last Updated
May 17, 2022
Sponsor
Texas State University, San Marcos
Collaborators
National Institute on Disability, Independent Living, and Rehabilitation Research
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1. Study Identification

Unique Protocol Identification Number
NCT04505488
Brief Title
Efficacy of the ASPEN Intervention Program in Low-Resource Communities
Acronym
ASPEN
Official Title
Efficacy of the ASD Screening and Parent ENgagement (ASPEN) Intervention Program in Low-Resource Communities
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 7, 2020 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas State University, San Marcos
Collaborators
National Institute on Disability, Independent Living, and Rehabilitation Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Autism, Parent-mediated intervention, Naturalistic developmental behavioral intervention, Low resource households

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
The intervention group will receive a parent manual, a resource packet, and 12 weekly sessions delivered by the clinician and peer leader.
Arm Title
Control Group
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
ASD Screening Parent ENgagement Intervention Program (ASPEN)
Other Intervention Name(s)
ASPEN
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adaptive Behavior
Description
Vineland Adaptive Behavior Scales - 3: Adaptive Behavior Composite Standard Score Minimum value = 20; Maximum value = 140; Higher scores indicate a better outcome
Time Frame
Baseline to Post-Intervention (12-14 weeks post baseline) Change
Title
Adaptive Behavior
Description
Vineland Adaptive Behavior Scales - 3: Adaptive Behavior Composite Standard Score Minimum value = 20; Maximum value = 140; Higher scores indicate a better outcome
Time Frame
Baseline to Follow-Up (24-28 weeks post baseline) Change
Title
Parenting Stress
Description
Parenting Stress Index - Short Form Total Stress T Score Minimum value = 32; Maximum value = 92; Higher scores indicate a worse outcome
Time Frame
Baseline to Post-Intervention (12-14 weeks post baseline) Change
Title
Parenting Stress
Description
Parenting Stress Index - Short Form Total Stress T Score Minimum value = 32; Maximum value = 92; Higher scores indicate a worse outcome
Time Frame
Baseline to Follow-Up (24-28 weeks post baseline) Change
Title
Parent Empowerment
Description
Family Outcomes Scales - Revised Minimum value = 1; Maximum value = 5; Higher scores indicate a better outcome
Time Frame
Baseline to Post-Intervention (12-14 weeks post baseline) Change
Title
Parent Empowerment
Description
Family Outcomes Scales - Revised Minimum value = 1; Maximum value = 5; Higher scores indicate a better outcome
Time Frame
Baseline to Follow-Up (24-28 weeks post baseline) Change
Secondary Outcome Measure Information:
Title
Child Challenging Behavior
Description
Scales of Independent Behavior-Revised: Problem Behavior Subscale Minimum value = +10; Maximum value = -74; Higher scores indicate a better outcome
Time Frame
Baseline to Post-Intervention (12-14 weeks post baseline) Change
Title
Child Challenging Behavior
Description
Minimum value = +10; Maximum value = -74; Higher scores indicate a better outcome
Time Frame
Baseline to Follow-Up (24-28 weeks post baseline) Change
Title
Family Quality of Life
Description
PedsQL Family Impact Module: Family Functioning Minimum value = 0; Maximum value = 100; Higher scores indicate a better outcome
Time Frame
Baseline to Post-Intervention (12-14 weeks post baseline) Change
Title
Family Quality of Life
Description
PedsQL Family Impact Module: Family Functioning Minimum value = 0; Maximum value = 100; Higher scores indicate a better outcome
Time Frame
Baseline to Follow-Up (24-28 weeks post baseline) Change

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sandra B Vanegas, PhD
Phone
5122454579
Email
svanegas@txstate.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sandy Magaña, PhD, MSW
Phone
5122329216
Email
smagana@austin.utexas.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra B Vanegas, PhD
Organizational Affiliation
Texas State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas State University
City
San Marcos
State/Province
Texas
ZIP/Postal Code
78666
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandra B Vanegas, PhD
Phone
512-245-4579
Email
svanegas@txstate.edu
First Name & Middle Initial & Last Name & Degree
Sandra B Vanegas, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
Data will be available 1 year after study completion.
IPD Sharing Access Criteria
Electronic data from assessments will be submitted to Inter-university Consortium for Political and Social Research within 1 year after study completion for archival and storage purposes.

Learn more about this trial

Efficacy of the ASPEN Intervention Program in Low-Resource Communities

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