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

58 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial compares two programs for young children with autism. One program trains parents to help their kids develop social and communication skills, while the other provides parents with information about autism. The study aims to see which program is more effective in improving children's skills and reducing parental stress.

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 treatment Pathways Intervention for Autism?

Research shows that care pathways, which guide clinicians through evidence-based care, have improved outcomes in various conditions like schizophrenia and asthma. These pathways help standardize care and ensure best practices, which could suggest potential benefits for autism treatment as well. ^{1 2 3 4 5}

Is the Pathways Intervention for Autism safe for humans?

There is limited safety data available for non-medication interventions like the Pathways Intervention for Autism. A review of 150 studies found that only a few reported adverse events or effects, suggesting a need for better reporting on safety in such interventions. ^{6 7 8 9 10}

How is the Pathways Intervention treatment for autism different from other treatments?

The Pathways Intervention is unique because it is a community-based, parent-mediated program that focuses on improving social interaction and communication skills in young children with autism. It involves weekly home visits where caregivers are trained to engage in face-to-face interactions and eye contact with their children, making it an accessible and practical option for families. ^{11 12 13 14 15}

Research Team

Pamela R Rollins, Ed.D

Principal Investigator

University of Texas at Dallas

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

References

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

Effect of introducing a care pathway to standardize treatment and nursing of schizophrenia. [2021]

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

A Strategy for the Renovation of a Clinical Pathways Program. [2022]

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

Pathways for Improving Inpatient Pediatric Asthma Care (PIPA): A Multicenter, National Study. [2020]

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

Successful incorporation of the Severe Head Injury Guidelines into a phased-outcome clinical pathway. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Mental health. For good measure. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Adverse event reporting in intervention research for young autistic children. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Prescription Drug Use and Polypharmacy Among Medicaid-Enrolled Adults with Autism: A Retrospective Cross-Sectional Analysis. [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

A Phase II Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Arbaclofen Administered for the Treatment of Social Function in Children and Adolescents With Autism Spectrum Disorders: Study Protocol for AIMS-2-TRIALS-CT1. [2021]

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

Role of risperidone in children with autism spectrum disorder. [2013]

10. England 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. [2021]

11. England pubmed.ncbi.nlm.nih.gov

A community-based early intervention program for toddlers with autism spectrum disorders. [2019]

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

Reexamining Pathways Early Autism Intervention in Children Before and After the Third Birthday: A Randomized Control Trial. [2023]

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

Development of a continuum of services for children and adults with autism and other severe behavior disorders. [2019]

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

Does an Autism Spectrum Disorder Care Pathway Improve Care for Children and Adolescents with ASD in Inpatient Psychiatric Units? [2018]

15. Switzerland pubmed.ncbi.nlm.nih.gov

Implementation of a Parent-Mediated Discrete Trial Teaching Intervention for Children with Autism Spectrum Disorder. [2023]