Pathways Intervention for Autism

Overseen By Sara R Brantley, M. Ed

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas at Dallas

Disqualifiers: Neurological, Genetic disorders, others

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

Compensation: Varies

Number of Visits: 5

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two methods to assist young children suspected of or diagnosed with autism. One group will receive the Pathways intervention, where parents learn specific techniques to enhance their child's social and communication skills. The other group will attend parent education sessions without direct child involvement. The trial aims to determine which method better supports children's development and reduces parental stress. Families who speak English or Spanish, live near Dallas, Texas, and have a child aged 12 to 42 months who may have autism could be a good fit. As an unphased trial, this study offers families a unique opportunity to contribute to understanding effective autism interventions for young children.

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 these interventions are safe for children with autism?

Research has shown that non-medication programs like Pathways are generally safe. In 150 studies on similar programs for young autistic children, only 11 reported any negative effects, indicating that such effects are rare. However, more safety information is needed. Pathways trains parents to help their children, avoiding medications and medical procedures, which typically reduces risks. Although specific safety information for Pathways is limited, current research suggests it is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Pathways Intervention for autism because it offers a unique approach to early intervention. Unlike traditional autism treatments, which often involve direct therapy with the child, this method uses a Naturalistic Developmental Behavioral Intervention (NDBI) that empowers parents through coaching. This parent-mediated model allows caregivers to integrate therapeutic techniques into everyday interactions, potentially leading to more consistent and personalized support for the child. This could enhance developmental outcomes compared to conventional methods that may not fully engage the family in the therapeutic process.

What evidence suggests that this trial's treatments could be effective for autism?

In earlier studies, the Pathways Intervention, one of the treatments in this trial, has shown promise in helping young children with autism improve their social communication and language skills. Research shows that this program, which involves parents, is more effective than traditional early childhood programs at boosting early social skills and reducing stress for parents. The approach uses natural methods that easily fit into daily life. Initial findings suggest that children whose parents participate in Pathways training develop better social and communication skills compared to other programs. Additionally, parents involved in Pathways often feel less stressed, which can further help their children's development. Therefore, Pathways might offer more benefits for both children with autism and their families. Another treatment arm in this trial is the Parent Education Intervention (PEI), which focuses on individual caregiver training without the child being present. ^{1 6 7 8 9}

Who Is on the Research Team?

Pamela R Rollins, Ed.D

Principal Investigator

University of Texas at Dallas

Are You a Good Fit for This Trial?

This trial is for families in Dallas, Texas with children aged 12-42 months who are diagnosed with or suspected of having autism. Participants must speak English or Spanish at home and have no other neurological or genetic disorders. The child's autism diagnosis needs to be confirmed by a specific test called ADOS-2.

Inclusion Criteria

live in Dallas Texas within a 30-mile radius of the downtown location of the UTD/Callier Center for Communication Disorders.

My primary home language is either English or Spanish.

has an ASD diagnosis corroborated by the Autism Diagnostic Observation Schedule (ADOS-2) administered by study researchers;

Exclusion Criteria

You do not meet the requirements to participate in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Pathways or PEI intervention for 24 weeks

24 weeks

4 visits (in-person) every 12 weeks

Follow-up

Participants are monitored for changes in social communication and language, and parenting stress

12 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Parent Education Intervention (PEI)
• Pathways Intervention

Trial Overview The study compares two interventions: Pathways, which involves parents in early autism intervention, and PEI, focused on parent education. It aims to see if Pathways improves social attention and language skills more effectively than PEI and reduces parental stress over a 24-week period.

How Is the Trial Designed?

Group I: Pathways Intervention Experimental Treatment 1 Intervention

Twenty-four weeks of a manualized Naturalistic Developmental Behavioral Intervention (NDBI) parent-mediated early autism intervention that uses a coaching model.

Group II: Parent Education Intervention (PEI) Active Control 1 Intervention

Twenty-four weeks of individual caregiver training without the child being present.

Who Is Running the Clinical Trial?

The University of Texas at Dallas

Lead Sponsor

Trials

71

Recruited

108,000+

Published Research Related to This Trial

Risperidone has been found to be effective and safe in treating specific behavioral issues in children with autism spectrum disorder (ASD), such as irritability, aggression, and hyperactivity, based on a review of double-blind, placebo-controlled trials.

However, risperidone does not significantly improve the core symptoms of autism, which include social skill impairments and communication difficulties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of risperidone in children with autism spectrum disorder. Chavez, B., Chavez-Brown, M., Rey, JA.[2013]

Out of 150 studies on non-medication interventions for young autistic children, only 11 reported any adverse events, highlighting a significant gap in safety reporting in this area of research.

Among the studies that did report on participant withdrawal, 10 identified reasons that could be classified as adverse events, suggesting that researchers need to improve their methods for tracking and reporting these occurrences to better inform families and professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse event reporting in intervention research for young autistic children. Bottema-Beutel, K., Crowley, S., Sandbank, M., et al.[2023]

The Pathways Early Autism Intervention program effectively improved eye contact, social engagement, and verbal reciprocity in four boys with autism spectrum disorder, as measured by a single-subject design with multiple baselines.

Parents found the intervention beneficial and easy to integrate into their daily routines, highlighting its potential for broader application in state-funded early intervention programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A community-based early intervention program for toddlers with autism spectrum disorders. Rollins, PR., Campbell, M., Hoffman, RT., et al.[2019]

Adults with autism spectrum disorders (ASD) have significantly higher rates of prescription drug use and polypharmacy compared to adults without ASD, with nearly 75% of those with ASD having over 20 prescription drug claims annually.

The study found that 85% of adults with ASD used at least one psychotropic medication, with common prescriptions including antipsychotics and anticonvulsants, highlighting the need for careful monitoring of treatment efficacy and safety due to the high rates of polypharmacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prescription Drug Use and Polypharmacy Among Medicaid-Enrolled Adults with Autism: A Retrospective Cross-Sectional Analysis. Vohra, R., Madhavan, S., Sambamoorthi, U., et al.[2020]

In a study involving 510 pediatric patients with autism spectrum disorder, aripiprazole demonstrated a high continuation rate of treatment, with 84.6% of patients still on the medication after 24 weeks, indicating its effectiveness and tolerability in real-world settings.

The treatment led to a significant reduction in irritability symptoms, as measured by the Aberrant Behavior Checklist, with a mean score change of -5.7 after 4 weeks, showing that aripiprazole can effectively manage irritability in children and adolescents with ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aripiprazole in the real-world treatment for irritability associated with autism spectrum disorder in children and adolescents in Japan: 52-week post-marketing surveillance. Sugimoto, Y., Yamamura, K., Takayama, T., et al.[2021]

The implementation of the ASD Care Pathway (ASD-CP) in a public hospital child psychiatric service led to a 40% reduction in the average length of hospital stays for youth with autism spectrum disorder, from 22.4 days to 13.4 days.

Crisis interventions, such as holds and restraints, decreased by 77% after the ASD-CP was implemented, indicating a potential improvement in the management of patients with ASD, although these results approached statistical significance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does an Autism Spectrum Disorder Care Pathway Improve Care for Children and Adolescents with ASD in Inpatient Psychiatric Units? Kuriakose, S., Filton, B., Marr, M., et al.[2018]

The renovation of the clinical pathways (CP) program at a children's hospital significantly improved efficiency, reducing the time to complete pathways from a median of 15 months to just 5 months, which is a 70% increase in efficiency.

Following the program's improvements, the hospital saw a 78% increase in the total number of clinical pathways developed, indicating enhanced multidisciplinary participation and better integration into the electronic health record.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Strategy for the Renovation of a Clinical Pathways Program. Pugh-Bernard, A., Nickels, S., Melendez, J., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9123830/

Reexamining Pathways Early Autism Intervention in ... We reexamined the efficacy of Pathways early autism intervention using generalized measures of social communication and language skills.

2. pathwaysndbi.com pathwaysndbi.com/pathways-research/

Pathways Research This study examined Pathways Early Autism Intervention, a community-based, parent-mediated, intensive behavioral and developmental intervention program.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4064565/

Predictors of Outcomes in Autism Early Intervention Response to early intervention programs in autism is variable. However, the factors associated with positive versus poor treatment outcomes remain unknown.

4. mentalhealthjournal.org mentalhealthjournal.org/articles/pathways-early-intervention-program-for-toddlers-with-autism.html

Pathways early intervention program for toddlers with autism Pathways was found to be more effective than traditional ECI programs in improving early foundational social communication skills and in reducing parental ...

5. cureus.com cureus.com/articles/400356-the-impact-of-early-intensive-behavioral-and-developmental-interventions-on-key-developmental-outcomes-in-young-children-with-autism-spectrum-disorder-a-narrative-review

The Impact of Early Intensive Behavioral and ... Autism Spectrum Disorder (ASD) affects multiple developmental domains, and early intervention is critical for optimizing long-term outcomes.

6. mentalhealthjournal.org mentalhealthjournal.org/articles/pathways-early-intervention-program-for-toddlers-with-autism.pdf

pathways-early-intervention-program-for-toddlers-with- ... Effects of a brief Early Start Denver. Model (ESDM)-based parent intervention on toddlers at risk for autism spectrum disorders: a randomized controlled trial.

7. withpower.com withpower.com/trial/phase-autism-spectrum-disorder-9-2022-92199

Pathways Intervention for Autism · Info for Participants Out of 150 studies on non-medication interventions for young autistic children, only 11 reported any adverse events, highlighting a significant gap in safety ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1876201825001418

Accelerating autism spectrum disorder care: A rapid review ... This rapid review examines these approaches' current applications, benefits, limitations, and ethical considerations while identifying key research gaps and ...

9. jamanetwork.com jamanetwork.com/journals/jamapediatrics/fullarticle/2784066

Effect of Preemptive Intervention on Developmental ... This randomized clinical trial examines whether preemptive intervention compared with usual care reduces the severity of autism symptoms and ...