OT Intervention Via Telehealth for Children With ASD and ADHD

Sponsor

Children's Hospital Medical Center, Cincinnati (Other)

Overall Status

Completed

CT.gov ID

NCT03957993

Collaborator

(none)

Enrollment

Location

Arms

16.8

Actual Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autism Spectrum Disorder Attention Deficit Hyperactivity Disorder	Other: Occupational Therapy via Telehealth Other: Standard of Care Occupational Therapy	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Single (Outcomes Assessor)

Masking Description:

The therapist who assesses the outcomes is a different therapist than the treating (intervention) therapist.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 6, 2018

Actual Primary Completion Date :

Dec 30, 2019

Actual Study Completion Date :

Dec 30, 2019

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229

Sponsors and Collaborators

Children's Hospital Medical Center, Cincinnati

Investigators

Principal Investigator: Karen Harpster, PhD, OTR/L, Children's Hospital Medical Center, Cincinnati

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Children's Hospital Medical Center, Cincinnati

ClinicalTrials.gov Identifier:

NCT03957993

Other Study ID Numbers:

2017-5623

First Posted:

May 21, 2019

Last Update Posted:

Jul 16, 2020

Last Verified:

Jun 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Disease

Attention Deficit Disorder with Hyperactivity

Autism Spectrum Disorder

Study Results

No Results Posted as of Jul 16, 2020