OT Intervention Via Telehealth for Children With ASD and ADHD

Not Applicable

Completed

• Conditions: Autism Spectrum Disorder; Attention Deficit Hyperactivity Disorder

• Registration Number: NCT03957993
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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.

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 Timeline

• Study Start: 2018-08-06
• Study First Submitted: 2019-05-10
• Study First Submitted QC: 2019-05-20
• Study First Posted: 2019-05-21
• Primary Completion: 2019-12-30
• Study Completion: 2019-12-30
• Status Verified: 2020-06
• Last Update Submitted: 2020-07-14
• Last Update Posted: 2020-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Goal Attainment Scale	Baseline and approximately 2 weeks after treatment (approximately 14 weeks after baseline measurement)	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)
Change in Canadian Occupational Performance Measure	Baseline and approximately 2 weeks after treatment (approximately 14 weeks after baseline measurement)	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).

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States