OT Intervention Via Telehealth for Children With ASD and ADHD

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03957993
• Other study ID #: 2017-5623
• Status: Completed
• Phase: N/A
• Start date: August 6, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: June 2020
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Autism Spectrum Disorder
• Disease

Intervention

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.
• Standard of Care Occupational Therapy
The caregiver and participant will be in the clinic receiving occupational therapy in-person with the occupational therapist.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)