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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the ASPEN Program for Autism treatment?

Research shows that parent-involved interventions, like the ASPEN Program, can improve communication skills and reduce symptoms in children with autism. Studies on similar programs have found that training parents to use behavioral strategies effectively helps children with autism make social and communication gains. ^{1 2 3 4 5}

Is the ASPEN Program for Autism safe for humans?

The studies reviewed focus on parent-training programs for autism, which are generally considered safe and do not increase parental stress. However, specific safety data for the ASPEN Program itself is not provided. ^{1 3 4 6 7}

How is the ASPEN Program for Autism different from other treatments for autism spectrum disorder?

The ASPEN Program is unique because it focuses on engaging parents in the screening and intervention process for autism spectrum disorder (ASD), enhancing their knowledge and self-efficacy in managing ASD symptoms. This approach is distinct from other treatments as it emphasizes parent education and involvement, which can improve parent-child interactions and provide cost-effective resources. ^{1 3 5 7 8}

Research Team

Sandra B Vanegas, PhD

Principal Investigator

University of Texas at Austin

Eligibility Criteria

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

My child is between 18 months and 6 years old.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Efficacy of a Parent-Implemented Pivotal Response Treatment for Children with Autism Spectrum Disorder. [2023]

2. United States 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. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

A Video Parent-Training Program for Families of Children with Autism Spectrum Disorder in Albania. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Pre-Post Effects of the Psychoeducational, Autism-Specific Parent Training FAUT-E. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Parent Education in Studies With Nonverbal and Minimally Verbal Participants With Autism Spectrum Disorder: A Systematic Review. [2021]

6. United States 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. [2021]

7. United States 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. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Factors associated with parent engagement in DIR/Floortime for treatment of children with autism spectrum disorder. [2022]