Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

OT Via Telehealth (ASD and ADHD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03957993
Recruitment Status : Recruiting
First Posted : May 21, 2019
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Attention Deficit Hyperactivity Disorder Other: Occupational Therapy via Telehealth Other: Standard of Care Occupational Therapy Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 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.
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 : August 6, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change in Goal Attainment Scale [ Time Frame: 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)

  2. Change in Canadian Occupational Performance Measure [ Time Frame: 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03957993


Contacts
Layout table for location contacts
Contact: Karen L Harpster, PhD, OTR/L 513-803-3604 karen.harspter@cchmc.org
Contact: Jason Long, PhD 513-803-3595 jason.long@cchmc.org

Locations
Layout table for location information
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Karen L Harpster, PhD, OTR/L    513-803-3604    kare.harpster@cchmc.org   
Contact: Jason Long, PhD    513-803-3595    jason.long@cchmc.org   
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati

Layout table for additonal information
Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT03957993     History of Changes
Other Study ID Numbers: 2017-5623
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make individual participant data available to other researchers.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Attention Deficit Disorder with Hyperactivity
Autism Spectrum Disorder
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Child Development Disorders, Pervasive