ASPEN Program for Autism

(ASPEN Trial)

Recruiting at 1 trial location

Overseen By Sandra B Vanegas, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas at Austin

Disqualifiers: Non-English/Spanish speaker, Age, No ASD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 16

320 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist parents of young children with autism or those at risk by offering the ASD Screening Parent ENgagement Intervention Program (ASPEN). ASPEN teaches effective communication and behavior strategies. It includes 12 sessions where parents receive guidance on child development and self-care, with coaching to apply these strategies at home. The trial divides participants into two groups: one receives the full program, and the other gets a manual and check-ins. Families may qualify if they have a child aged 18 months to 6 years with autism or at risk, and live in a low-resource household (such as having Medicaid or a lower income). As an unphased trial, this study provides families the chance to access potentially beneficial strategies and support early in their child's development.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the ASPEN program is safe for young children with developmental delays?

Research shows that the ASPEN Program is a parent-led approach, where parents learn methods to assist their children. Studies have found that programs like ASPEN, which focus on parents, are generally well-received. They offer education and support, ensuring safety for both parents and children. No reports of problems or safety issues have emerged with the ASPEN Program itself, suggesting it is a safe choice for families seeking to help their children with developmental delays. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ASPEN Program for Autism because it takes a fresh approach by directly involving parents in the intervention process. Unlike traditional therapies that often rely solely on clinician-led sessions, ASPEN combines a parent manual, resource packet, and structured weekly sessions delivered by both a clinician and a peer leader. This dual approach is designed to enhance parent engagement and empowerment, potentially leading to more sustainable, long-term benefits for children with autism spectrum disorder (ASD). This method not only fosters a supportive community but also equips parents with practical tools and knowledge to support their child's development.

What evidence suggests that the ASPEN Program is effective for autism?

Research has shown that programs like ASPEN, which actively involve parents, can significantly aid children with autism. One study found that these programs enhance children's development by teaching parents how to support their child's learning. In this trial, the ASPEN program provides parents with tools to address social and behavioral issues. Participants in the intervention group will receive 12 weekly sessions led by a clinician and peer leader. Studies suggest this approach can enhance learning and provide social support, leading to improved family relationships. Meanwhile, the control group will receive a parent manual and resource packet with phone check-ins. Research also indicates that programs like ASPEN, which consider cultural differences, effectively engage parents and improve outcomes for both children and parents. ^{1 2 3 6 7}

Who Is on the Research Team?

Sandra B Vanegas, PhD

Principal Investigator

University of Texas at Austin

Are You a Good Fit for This Trial?

This trial is for primary caregivers of children aged 18 months to 6 years who have or are at risk for Autism/ASD, based on specific assessments. Caregivers should have a high school education or less, live in low-income households (200% below the Federal Poverty Level), and have Medicaid.

Inclusion Criteria

-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

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

The intervention group receives 12 weekly sessions delivered by a clinician and peer leader, focusing on psychoeducation and coaching for parents.

12 weeks

12 sessions (in-person or virtual)

Control

The control group receives a parent manual and resource packet with four phone check-ins.

12-14 weeks

4 phone check-ins

Follow-up

Participants are monitored for changes in adaptive behavior, parenting stress, and parent empowerment.

12-14 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ASD Screening Parent ENgagement Intervention Program (ASPEN)

Trial Overview The ASPEN program aims to improve social communication and behavior in young children with developmental delays through parent-mediated intervention. It includes psychoeducation, evidence-based strategies coaching, and support over 12 sessions by student clinicians and peer leaders.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

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

Group II: Control Group Active Control 1 Intervention

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.

ASD Screening Parent ENgagement Intervention Program (ASPEN) is already approved in United States for the following indications:

Approved in United States as ASPEN Program for:

• Developmental delays in young children
• Social communication difficulties
• Behavioral difficulties in early childhood

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials

387

Recruited

86,100+

Texas State University, San Marcos

Lead Sponsor

Trials

6

Recruited

540+

National Institute on Disability, Independent Living, and Rehabilitation Research

Collaborator

Trials

83

Recruited

10,500+

Published Research Related to This Trial

A video-enriched parent-training program for parents of children with Autism Spectrum Disorder (ASD) in Albania was found to be comprehensible and valuable, indicating its potential for effective delivery in low-resource settings.

The program modestly improved parents' knowledge of behavioral strategies and increased their self-efficacy, suggesting it could help parents develop effective teaching techniques for their children with ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Video Parent-Training Program for Families of Children with Autism Spectrum Disorder in Albania. Dai, YG., Brennan, L., Como, A., et al.[2022]

Involving parents in interventions for children with Autism Spectrum Disorder (ASD) is crucial, especially for Latinx families, as it enhances education about ASD, improves parent-child interactions, and provides access to resources.

Cultural factors such as language, family dynamics, community support, and the therapeutic relationship must be considered when designing interventions for Latinx families to ensure effective participation and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using the Ecological Validity Model to adapt parent-involved interventions for children with Autism Spectrum Disorder in the Latinx community: A conceptual review. Martinez-Torres, K., Boorom, O., Nogueira Peredo, T., et al.[2023]

Out of 1,231 studies evaluated, only 36 included a parent education component aimed at improving expressive verbal communication in nonverbal or minimally verbal children with autism spectrum disorder, highlighting a significant gap in research.

The review found considerable variability in the design and implementation of parent education programs, with unclear descriptions and few studies measuring how well parents implemented the interventions, suggesting a need for more standardized approaches in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent Education in Studies With Nonverbal and Minimally Verbal Participants With Autism Spectrum Disorder: A Systematic Review. Koegel, LK., Bryan, KM., Su, PL., et al.[2021]

The FAUT-E parent training program significantly improved children's behavior, as evidenced by a medium effect size on the Aberrant Behavior Checklist after the intervention and at a follow-up three months later, indicating its efficacy in managing behaviors associated with autism spectrum disorder.

The training was easy to implement and did not increase parental stress, suggesting it is a safe and practical option for parents of children newly diagnosed with ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-Post Effects of the Psychoeducational, Autism-Specific Parent Training FAUT-E. Medda, JE., Kitzerow, J., Schlitt, S., et al.[2021]

The six-week parent training program for Pivotal Response Treatment (PRT) effectively taught four parents to implement the intervention with high fidelity, enhancing their interactions with their children with autism spectrum disorder (ASD).

Parents reported high satisfaction with the program, indicating that PRT parent training is a promising, efficient, and cost-effective treatment model for improving parent-child interactions in ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a Parent-Implemented Pivotal Response Treatment for Children with Autism Spectrum Disorder. Bozkus-Genc, G., Yucesoy-Ozkan, S.[2023]

Parents who are married, have lower income, and possess a better understanding of DIR/Floortime theory are more likely to engage effectively in the treatment, which is crucial for children with autism spectrum disorder (ASD).

Higher levels of parental engagement in DIR/Floortime techniques, particularly when practiced for more than one hour a day, are significantly associated with better developmental outcomes for children with ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors associated with parent engagement in DIR/Floortime for treatment of children with autism spectrum disorder. Praphatthanakunwong, N., Kiatrungrit, K., Hongsanguansri, S., et al.[2022]

In a pilot study involving 30 young children with Autism Spectrum Disorder (ASD), the Project ImPACT intervention showed significant improvements in child communication skills after 12 weeks compared to a community comparison group.

The study also found that higher parenting stress at the beginning negatively impacted the social gains of children, highlighting the importance of addressing parent factors in interventions for ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Effectiveness of Project ImPACT: A Parent-Mediated Intervention for Children with Autism Spectrum Disorder Delivered in a Community Program. Stadnick, NA., Stahmer, A., Brookman-Frazee, L.[2023]

A new online program for caregivers of children with Autism Spectrum Disorder (ASD) was developed to help parents learn effective interventions, and about two-thirds of the enrolled parents completed all 14 modules.

Parents found the program to be clear, enjoyable, and useful, reporting improvements in their children's skills and behavior, highlighting its potential as a valuable resource despite some barriers to completion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Acceptability of a New Program for Caregivers of Children with Autism Spectrum Disorder: Online Parent Training in Early Behavioral Intervention. Dai, YG., Thomas, RP., Brennan, L., et al.[2021]

Citations

1. socialwork.utexas.edu socialwork.utexas.edu/projects/efficacy-of-the-asd-screening-and-parent-engagement-aspen-intervention-program-in-low-resource-communities/

Efficacy of the ASD Screening and Parent ENgagement ... The goal of this project is to examine the efficacy of the ASPEN intervention, a culturally-informed parent-mediated intervention (PMI) program when delivered ...

2. withpower.com withpower.com/trial/phase-autism-spectrum-disorder-6-2020-7c591

ASPEN Program for Autism (ASPEN Trial) The ASPEN Program is unique because it focuses on engaging parents in the screening and intervention process for autism spectrum disorder (ASD), enhancing their ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11017782/

Advances in Supporting Parents in Interventions for Autism ... Parents and caregivers should be involved in intervention programs for children with autism spectrum disorder (ASD) to improve developmental outcomes and reduce ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10539413/

Effects of Parent-Implemented Interventions on Outcomes ... Children with autism spectrum disorder (ASD) have been shown to benefit from parent-implemented interventions (PIIs). This meta-analysis ...

5. aspenprogramtx.org aspenprogramtx.org/

ASPEN Program The ASD Screening and Parent ENgagement (ASPEN) Program is a parent-mediated intervention program, that is, parents are trained to be the primary ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9340799/

Adapting parent-focused interventions for diverse caregivers ... The ASD Screening and Parent ENgagement (ASPEN) intervention program used a randomized controlled trial to measure the efficacy of parent education combined ...

7. disabilitystudies.utexas.edu disabilitystudies.utexas.edu/aspen

ASPEN Program - the Texas Center for Disability Studies The ASPEN Program is a parent-mediated intervention that is designed to provide information and empower parents of young children with developmental delays.