OT Intervention Via Telehealth for Children With ASD and ADHD

NCT03957993 | Completed

• 1 other identifier: 2017-5623
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autism Spectrum Disorder; Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (2)

Occupational Therapy via Telehealth

EXPERIMENTAL

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

Standard of Care Occupational Therapy

ACTIVE COMPARATOR

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

Interventions

Occupational Therapy via Telehealth OTHER

The caregiver will be with the participant in their home environment receiving occupational therapy via Telehealth (video-calling) with the occupational therapist.

Occupational Therapy via Telehealth

Standard of Care Occupational Therapy OTHER

The caregiver and participant will be in the clinic receiving occupational therapy in-person with the occupational therapist.

Standard of Care Occupational Therapy

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders

Study Officials

• Karen Harpster, PhD, OTR/L

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The therapist who assesses the outcomes is a different therapist than the treating (intervention) therapist.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomized to the Telehealth arm of the study or the Standard Care arm of the study.

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: May 21, 2019
• Study Start: August 6, 2018
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: July 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)