Efficacy of the ASPEN Intervention Program in Low-Resource Communities

NCT ID: NCT04505488

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-07

Study Completion Date

2025-09-29

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.

Detailed Description

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Conditions

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Autism Spectrum Disorder

Keywords

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Autism Parent-mediated intervention Naturalistic developmental behavioral intervention Low resource households

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention Group

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

Group Type EXPERIMENTAL

ASD Screening Parent ENgagement Intervention Program (ASPEN)

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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ASPEN

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
Minimum Eligible Age

18 Months

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Disability, Independent Living, and Rehabilitation Research

FED

Sponsor Role collaborator

University of Texas at Austin

OTHER

Sponsor Role lead

Responsible Party

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Sandra B. Vanegas

Research Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sandra B Vanegas, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Austin

Locations

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University of Texas at Austin

Austin, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sandra B Vanegas, PhD

Role: CONTACT

Phone: 5122454579

Email: [email protected]

Sandy MagaƱa, PhD, MSW

Role: CONTACT

Phone: 5122329216

Email: [email protected]

Facility Contacts

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Sandra B Vanegas, PhD

Role: primary

Other Identifiers

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90IFST0004

Identifier Type: -

Identifier Source: org_study_id