Telehealth Intervention for Autism Spectrum Disorder

NCT04832152 | Recruiting

• 1 other identifier: 412579-19406
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (2)

• Daily Living Skills Change Score - Pediatric Evaluation of Disabilities Inventory

  Change in daily living skills (on a scale of 0 to 25) measured with the Pediatric Evaluation of Disabilities Inventory. Change score range 0-25; higher score means better outcome.

  up to 14 weeks

• Pervasive Developmental Disorders Behavioral Inventory T Score Autism Behaviors

  Change is autism behaviors and sensory approach behaviors. Raw scores are converted to T Score. Minimum = 10 Maximum = 80

  up to 14 weeks

Secondary Outcomes (2)

• Goal Attainment Scale T Score

  up to 14 weeks

• Sensory Processing Measure

  up to 14 weeks

Study Arms (1)

Feasibility trial group

OTHER

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

Other: OT4ASD

Interventions

OT4ASD 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.

Feasibility trial group

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Montefiore Medical Center: collaborator

Study Sites (1)

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

The Bronx, New York, 10461, United States

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Roseann C Schaaf, PhD

CONTACT

6102912179; roseann.schaaf@jefferson.edu

Rachel L Dumont, M.S.

CONTACT

6107641035; rachel.dumont@jefferson.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: none. This is a feasiblity trial
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The purpose of this project is to adapt an existing, evidence-based occupational therapy intervention for children with ASD to a telehealth delivery model. The main objectives of the project are to 1) adapt the manual so that it operationalizes best-practices of occupational therapy telehealth50,51, 2) test its feasibility, and 3) evaluate preliminary outcomes. Design: In the formative research aspect of this project will use survey methodology and a modified Delphi process to adapt our current intervention to a telehealth delivery model (Aim 1). In Aim 2 we will conduct a feasibility trial (Figure 2) to assess therapists' fidelity, participant recruitment and retention, acceptability of the protocol by parents and therapists, and clinically meaningful differences.

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: April 5, 2021
• Study Start: March 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available following completion of the study and publication of findings.
• Access Criteria: Upon written request (reviewed by principal investigator) information will be shared.

Locations

US (1)