OT Intervention Via Telehealth for Children With ASD and ADHD

Pilot Study: Addressing Home-Based Functional Challenges Via Telehealth-Based Occupational Therapy

This study aims to measure the impact of a telehealth-based model of occupational therapy (OT) treatment on clinical outcomes for children with autism spectrum disorder (ASD) and/or attention deficit hyperactivity disorder (ADHD). Half of the participants will receive clinic-based, in-person services and half of the participants will receive video-based, Telehealth services.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder; Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Other: Occupational Therapy via Telehealth; Other: Standard of Care Occupational Therapy

Detailed Description

Children with autism spectrum disorder (ASD) and/or attention deficit hyperactivity disorder (ADHD) often receive occupational therapy (OT), which traditionally takes place in a clinical setting. This setting may present barriers and distractors that make it hard for children to achieve their OT goals. Telehealth-based sessions provide an alternative, allowing the therapist to be virtually present within the home.Once enrolled, children will randomly be assigned to be in one of two groups: (1) Standard, in which children will receive clinic-based services as per standard of care OR (2) Telehealth, in which children will receive in-home services on a video-based platform on a timeline identical to what they would receive if they were in the Standard group. Children in both groups will participate for the duration of the episode of care, estimated to last 10-12 weeks. Assessments will be completed at initial evaluation, discharge, and three months following discharge.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Has a Autism Spectrum Disorder and/or Attention Deficit Hyperactivity Disorder
• Has an active occupational therapy referral
• Has occupational therapy goals that are directly related to performance of activities of daily living that might reasonably be affected by the environment (as determined by an evaluating therapist)

Exclusion Criteria:

• Does not have Autism Spectrum Disorder or Attention Deficit Hyperactivity Disorder
• Does not have an active occupational therapy referral
• Does not have occupational therapy goals that are directly related to performance of activities of daily living that might reasonably be affected by the environment (as determined by an evaluating therapist)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Occupational Therapy via Telehealth; Participants in the telehealth-based model will undergo occupational therapy treatment via a telehealth-based video chat platform for the entire episode of care (generally 10-12 weeks in duration). The patient will use the video chat client to connect to his/her occupational therapist, and the therapist will conduct the session over this virtual connection.	Other: Occupational Therapy via Telehealth; The caregiver will be with the participant in their home environment receiving occupational therapy via Telehealth (video-calling) with the occupational therapist.
Active Comparator: Standard of Care Occupational Therapy; Participants in the standard of care model will undergo occupational therapy treatment via traditional in- person encounters in an outpatient clinic setting for the entire episode of care (generally 10-12 weeks). These children will receive routine occupational treatment via in-person sessions with an occupational therapist conducted in an outpatient clinic setting.	Other: Standard of Care Occupational Therapy; The caregiver and participant will be in the clinic receiving occupational therapy in-person with the occupational therapist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Goal Attainment Scale	The Goal Attainment Scale is a criterion-referenced, individualized outcome measure used to assess progress on goals that are important to the child and their family. The Goal Attainment Scale is reliable, valid and responsive to change. The status of goal attainment is rated on a scale of +2 to -2 (+2 is much more than expected, -2 is much less than expected)	Baseline and approximately 2 weeks after treatment (approximately 14 weeks after baseline measurement)
Change in Canadian Occupational Performance Measure	The Canadian Occupational Performance Measure is a valid, reliable, and sensitive assessment tool that measures the caregiver/patient's perception of the participant's performance and satisfaction on goals that are important to the child and his/her caregiver. The performance and satisfaction are rated on a scale from 1-10 (1 is low performance/satisfaction, 10 is high performance/satisfaction).	Baseline and approximately 2 weeks after treatment (approximately 14 weeks after baseline measurement)

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2018
• Primary Completion (Actual): December 30, 2019
• Study Completion (Actual): December 30, 2019

Study Registration Dates

• First Submitted: May 10, 2019
• First Submitted That Met QC Criteria: May 20, 2019
• First Posted (Actual): May 21, 2019

Study Record Updates

• Last Update Posted (Actual): July 16, 2020
• Last Update Submitted That Met QC Criteria: July 14, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Disease; Attention Deficit Disorder with Hyperactivity; Autism Spectrum Disorder
• Other Study ID Numbers: 2017-5623

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is not a plan to make individual participant data available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No