Recruiting

Telehealth Intervention

Sponsor:

Thomas Jefferson University

Code:

NCT04832152

Conditions

Autism Spectrum Disorder

Eligibility Criteria

Sex: All

Age: 4 - 12

Healthy Volunteers: Accepted

Interventions

OT4ASD

Study Details

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

Study ID

NCT04832152

Start date

Mar 1, 2023

Status verified date

Apr, 2024

Completion date

Jun 30, 2024

Anticipated

Primary completion date

Jun 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 12

Healthy Volunteers: Accepted

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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Feasibility trial group

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

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.

Primary outcome measure

  • Daily Living Skills Change Score - Pediatric Evaluation of Disabilities Inventory [ Time Frame: up to 14 weeks ]
  • Pervasive Developmental Disorders Behavioral Inventory T Score Autism Behaviors [ Time Frame: up to 14 weeks ]

Central Contacts and Locations

Central contacts

Locations

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

Recruiting

Bronx, New York, United States, 10461

Contacts

More Information

Sponsor

Thomas Jefferson University

Last update posted

Apr 22, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2024-04-22.