Telehealth Intervention for Autism Spectrum Disorder

NCT ID: NCT04832152

Last Updated: 2024-04-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-06-30

Brief Summary

Autism Spectrum Disorder (ASD) is one of the most frequently occurring childhood-onset neurodevelopmental disorders affecting 1 in every 54 children. Most children with ASD experience challenges participating in daily activities (e.g.: eating, sleeping, bathing, grooming, playing, etc.) and receive occupational therapy intervention to address these. The COVID-19 pandemic has restricted in-person therapy for many of these children and there is an urgent need for evidence-based, validated telehealth intervention. This project will adapt an evidence-based occupational therapy intervention, termed OT4ASD to a telehealth delivery model. The aims of the project are to: 1) adapt the existing intervention protocol to a telehealth delivery model, 2) train therapists and evaluate the therapist's ability to conduct OT4ASD, 3) determine if OT4ASD delivered via the telehealth is acceptable and feasible to parents and interventionists; and 4) whether children improve in the daily living skills. OT4ASD follows a systematic protocol and uses active, individually-tailored sensory motor activities that are specifically designed to address the child's needs. The investigators believe this will be the first telehealth manualized protocol to address the sensory motor symptoms of ASD and measure outcomes at the daily life activity and participation levels.

Detailed Description

Autism Spectrum Disorder (ASD) is one of the most frequently occurring childhood-onset neurodevelopmental disorders affecting 1 in every 54 children1. As a lifelong condition, individuals with ASD experience a range of intellectual, behavioral, sensory, motor, and functional challenges that impact successful participation in daily life activities and tasks. As a result, occupational therapy (OT) intervention is a frequently requested and utilized service in ASD, and clinically validated OT approaches are needed. In a series of studies funded by the NIH and autism foundations, our team manualized and studied an OT intervention that targets the sensory and motor factors impacting participation in daily life activities and tasks and showed significant improvements in those that received the intervention in comparison to controls 2-4. In this project, the investigators plan to adapt our existing protocol to a telehealth model of service delivery, and evaluate its feasibility and preliminary effectiveness.

The COVID-19 global pandemic created a call to action for healthcare providers to design unique and innovative methods for therapeutic service delivery. This shift creates an urgent need for remote solutions so that therapeutic services can be delivered in safely and effectively. Since the onset of the COVID-19 pandemic, families have reported regression in adaptive functioning in addition to a negative impact on social skills and increased anxiety, and an impact to daily routines of children with ASD5. In a recent survey of families with children with ASD, 95% of the parents reported that disruptions in services/therapies negatively impacted their child's behaviors and only 35% of families were receiving telehealth services/therapies6. To address these increased needs for children with ASD and to meet the need of manualized telehealth intervention, the investigators propose to adapt the existing intervention to a telehealth delivery model. This intervention, termed occupational therapy for children with Autism Spectrum Disorder (OT4ASD) targets the sensory motor factors that impact behavior and participation in life activities and tasks. This project is significant in that it will address the need for evidence-based OT services for children with ASD using an innovative telehealth model. Given that many children with ASD require treatment for the sensory and motor symptoms that impact their optimal participation in a range of daily life activities and tasks, and that the current COVID 19 pandemic has compromised access to this therapy, this project is urgently needed.

Innovation: Telehealth offers an emerging and innovative approach for OT intervention. Research shows that children with ASD require intensive intervention to assure best outcomes and telehealth offers an innovative solution for providing therapy during a pandemic. To the investigator's knowledge, this will be the first telehealth manualized protocol to address the sensory motor symptoms of ASD and measure outcomes at the activity and participation levels of the ICF framework. Importantly, the investigators will adapt an evidence-based, manualized intervention with solid data on outcomes to a telehealth model. The protocol will operationalize the data-driven decision making (DDDM) approach into an on-line format. DDDM is innovative in that it explicitly guides the therapist to contextualize intervention within the child and family's real life participation challenges and use data from assessment to individualize the intervention. DDDM measures outcomes at the proximal (sensory and motor factors) and distal (functional/participation-based goals) levels facilitating an intervention that is context-specific and participation-oriented.

Methods: The project will first adapt the existing protocol into a telehealth delivery model using a formative approach that includes a modified Delphi process to obtain input and consensus from experts in telehealth and autism interventions and key stakeholders (parents and clinical interventionists). Next, the investigators will conduct a feasibility trial to assess the acceptability, satisfaction and implementation fidelity as well as gather data on clinically meaningful outcomes. Outcomes will be measured at the proximal and distal levels using validated outcome measures to assure information gained is relevant and scientifically rigorous. Data from the feasibility trial will be used to support an R01 application to conduct a randomized trial of OT4ASD.

To implement the project, the investigators utilize a highly skilled team of clinicians and scientists with experience in conducting randomized trials in autism who will work collaboratively to translate knowledge gained into useful information that will impact the lives of families and children with ASD. Our approach is consistent with contemporary models of evidence-based practice and rehabilitation science promoting promote high integrity, evidence-based information from research that targets relevant and meaningful areas for each child and family. The timeline is ambitious and the investigators feel well-equipped to meet it given past experiences and expertise.

In summary, this project addresses an urgent need to provide rehabilitation services to children with ASD using remote technology. It will operationalize best practices in telehealth to adapt an existing evidence-based OT intervention and utilize a skilled and experienced team of investigators. As such, this project is consistent with the AACPDM mission to promote excellence in research and services for persons with childhood-onset disabilities.

Conditions

Autism Spectrum Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Feasibility trial group

One group (arm) trial where all will receive treatment.

Group Type: OTHER

OT4ASD

Intervention Type: OTHER

Occupational therapy will focus on education and coaching of families/caregivers of children with autism spectrum disorder to help them adapt their daily routines to address their child's sensory needs.

Interventions

OT4ASD

Occupational therapy will focus on education and coaching of families/caregivers of children with autism spectrum disorder to help them adapt their daily routines to address their child's sensory needs.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Diagnosis of Autism Spectrum Disorder
• Between the ages of 4 years 0 months and 12 years 0 months
• Evidence of sensory symptoms based on the Sensory Processing Measure
• Family is willing to participate
• Physically able to participate in active, sensorimotor activities

Exclusion Criteria

• Primary (visual or auditory) uncorrected sensory deficits
• Do not meet age or diagnostic criteria

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Montefiore Medical Center

OTHER

Sponsor Role: collaborator

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rose R. Kennedy Children's Evaluation and Rehabilitation Center (CERC) at Montefiore

The Bronx, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Roseann C Schaaf, PhD

Role: CONTACT

roseann.schaaf@jefferson.edu

6102912179

Rachel L Dumont, M.S.

Role: CONTACT

rachel.dumont@jefferson.edu

6107641035

Facility Contacts

Elizabeth C Ridgway, OTD

Role: primary

elizabeth.ridgway@einsteinmed.org

718-839-7101

Daniella Soba, OTD

Role: backup

dsoba@montefiore.org

718-839-7104

Other Identifiers

412579-19406

Identifier Type: -

Identifier Source: org_study_id