What side effects are associated with this type of intervention?

Parent-mediated early interventions for autism spectrum disorder, such as the Pathways program, generally focus on improving social communication, joint attention, and language development while reducing parental stress. These interventions are typically behavioral and educational in nature and are considered low-risk. Common side effects are minimal but may include temporary increases in parental stress or frustration as they learn and implement new strategies. There are no significant adverse effects reported for these types of interventions, making them a safe option for early autism treatment.

What other types of research exist?

<ol> <li>Navigator ACT: A manualized Acceptance and Commitment Therapy group intervention for parents of children with disabilities, including autism, aimed at reducing parental distress and improving coping strategies.</li> <li></li> </ol> BVERS (Building Vocabulary and Early Reading Strategies): An 11-week listening comprehension intervention delivered remotely, with a parent instructional component, showing feasibility and parental satisfaction. 3. Online Executive Function Training: An online parent training program for executive function intervention, developed with stakeholder guidance, showing positive feedback from parents.

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Behavioural Intervention

Pathways Intervention for Autism

Q: What prior FDA approvals exist?

The FDA has approved several medications for the treatment of irritability associated with Autism Spectrum Disorder (ASD), such as risperidone and aripiprazole. However, there are no specific FDA-approved drugs that directly target social orienting, joint attention, social communication, and language development. Most interventions in these areas are behavioral and educational rather than pharmacological. The Pathways trial, which focuses on parent-mediated early autism intervention, represents a non-pharmacological approach aimed at these developmental areas.

N/A

Recruiting

Led By Pamela R Rollins, Ed.D

Research Sponsored by The University of Texas at Dallas

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

are between 12-42 months old at the start of the study;

have no other known neurological or genetic concerns or disorders;

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed for changes from baseline to 24 weeks and from 24-to-36 weeks

Awards & highlights

Summary

This trial tests if Pathways is better than PEI for helping autistic children develop social skills and reducing parental stress. Parents enrolled will receive one of two treatments and assessments of their child at intervals.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial focuses on educational interventions rather than medications, traditional side effects are not applicable. However, there may be varying levels of stress or emotional impact associated with the intensity of the programs on both children and their parents.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My child is between 1 and 3.5 years old.

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I do not have any known neurological or genetic disorders.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed for changes from baseline to 24 weeks and from 24-to-36 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed for changes from baseline to 24 weeks and from 24-to-36 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed for changes from baseline to 24 weeks and from 24-to-36 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in child language

Change in child social communication

Changes in child Joint attention

+2 more

Secondary outcome measures

Changes in motor skills

Changes in parenting stress

changes in child adaptive functioning

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Pathways InterventionExperimental Treatment1 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 Control1 Intervention

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

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Parent-mediated early interventions for Autism, such as the Pathways program, work by training parents to use targeted strategies to enhance their child's social orienting, joint attention, social communication, and language development during daily interactions. These interventions leverage the natural parent-child relationship to create a consistent and supportive learning environment, leading to meaningful improvements in the child's abilities. Additionally, reducing parental stress through these programs is essential as it fosters a more stable and nurturing family dynamic, which is beneficial for the child's overall development.

Novel treatments in autism spectrum disorder.Pharmacological and dietary-supplement treatments for autism spectrum disorder: a systematic review and network meta-analysis.Parent-mediated early intervention for young children with autism spectrum disorders (ASD).