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OpenTrials
Completed

NCT Number: NCT03957993

OT Intervention Via Telehealth for Children With ASD and ADHD

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.

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Key information

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Standard of Care Occupational Therapy

Other

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

Primary outcomes

  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).

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 21, 2019
Registry last updated
Jul 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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