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Comparing Behavioral Assessments Using Telehealth for Children With Autism

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard FA+FCT
Pragmatic FA+FCT
Sponsored by
Matthew J O'Brien, PhD, BCBA-D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Telehealth, Applied behavior analysis

Eligibility Criteria

18 Months - 83 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Confirmed diagnosis of autism spectrum disorder
  • Significant behavior problems requiring treatment
  • At least one parent willing to be trained in behavior analysis via telehealth

Exclusion Criteria:

  • Unstable or degenerative neurological disorder

Sites / Locations

  • University of Iowa

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard FA+FCT

Pragmatic FA+FCT

Arm Description

Parents are coached via weekly telehealth visits to use Functional Analysis (FA) to assess problem behavior and Functional Communication Training (FCT) to treat the problem behavior identified.

Parents are coached via weekly telehealth visits to use a brief, streamlined version of Functional Analysis (FA) to assess problem behavior and to follow that assessment with Functional Communication Training (FCT) to treat the problem behavior identified. The version of FCT used in the Pragmatic arm involves significantly less data scoring and graphing than the version used in the Standard arm.

Outcomes

Primary Outcome Measures

Percent Reduction in Problem Behavior
Rate of problem behavior (destruction, aggression, self-injury, noncompliance, etc.) is computed by scoring the frequency of these target behaviors during observation sessions completed before treatment and at the end of treatment.

Secondary Outcome Measures

Full Information

First Posted
May 26, 2015
Last Updated
October 2, 2020
Sponsor
Matthew J O'Brien, PhD, BCBA-D
Collaborators
University of Houston, Emory University, Children's Healthcare of Atlanta, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT02456298
Brief Title
Comparing Behavioral Assessments Using Telehealth for Children With Autism
Official Title
Comparing Behavioral Assessments Using Telehealth for Children With Autism
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
May 31, 2020 (Actual)
Study Completion Date
May 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Matthew J O'Brien, PhD, BCBA-D
Collaborators
University of Houston, Emory University, Children's Healthcare of Atlanta, National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The main purpose of this study is to determine the most efficient way for families to reduce problem behavior in their children with an autism spectrum disorder. Parents will be trained using telehealth to use applied behavior analysis (ABA) procedures to improve child behavior and communication. The study compares an established type of ABA assessment and treatment to a briefer, more streamlined version of this same type of assessment/treatment.
Detailed Description
Managing challenging behavior in autism spectrum disorders (ASD) can profoundly improve quality of life for children and families. However, many families lack access to research-based treatment, such as applied behavior analysis (ABA). This study is a randomized trial comparing outcomes of treatment for ASD using either a standard Functional Analysis Plus Functional Communication Training (FA+FCT) package or a pragmatic version that offers a briefer, less time-intensive model of FA+FCT. Both types of FA+FCT are provided via telehealth in family homes to maximize generalizability to real-life settings. Providing ABA through telehealth makes an effective treatment accessible across geographic barriers so that no child is excluded based on where they live. The study also examines key family factors that influence successful outcomes. The study has 3 primary aims: (1) To assess outcomes for ABA telehealth by assigning children to either a Pragmatic FA+FCT group or to a group receiving Standard FA+FCT. Outcomes will be compared based on the percent reduction in problem behavior, communication increases, time to achieve outcomes, treatment fidelity, family acceptance of treatment, and generalization and maintenance of treatment gains. (2) The study will assess the relation of family factors to treatment efficacy and acceptability by assessing parent stress, mood, and social support in relation to outcomes. (3) Cost effectiveness will be assessed in relation to the treatment methods used and the efficiency of ABA telehealth. The study will include 102 children who meet eligibility criteria from among a larger sample of 150 children. Thirty-six children will receive intervention in each of three states: Iowa, Georgia, and Texas. Study design is a randomized trial using an intent-to-treat analysis. Half of the sample will be randomized to Pragmatic FA+FCT and half to Standard FA+FCT. Treatment will be provided via telehealth using FCT, which is a function-based ABA technique in which parents are trained to be therapists under the direction of behavior consultants. Study procedures typically are completed within 6 months, and follow-up assessments occur 6 months after treatment completion. Data analyses include comparisons between assessment groups, single-case designs examining responses in individual children, cost analyses, and regression analyses of the effects of family factors on outcomes. The investigators prior research shows that problem behavior can be reduced by over 90% in most children with ASD after 4-6 months of telehealth treatment. If Pragmatic FA+FCT can reduce problem behavior at rates comparable to Standard FA+FCT, then treatment can be started sooner and families can achieve successful outcomes at lower cost. Although pragmatic FA+FCT provides less behavioral information, it may be more resistant to treatment relapse because it does not involve reinforcing high rates of problem behavior.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Telehealth, Applied behavior analysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
152 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard FA+FCT
Arm Type
Active Comparator
Arm Description
Parents are coached via weekly telehealth visits to use Functional Analysis (FA) to assess problem behavior and Functional Communication Training (FCT) to treat the problem behavior identified.
Arm Title
Pragmatic FA+FCT
Arm Type
Experimental
Arm Description
Parents are coached via weekly telehealth visits to use a brief, streamlined version of Functional Analysis (FA) to assess problem behavior and to follow that assessment with Functional Communication Training (FCT) to treat the problem behavior identified. The version of FCT used in the Pragmatic arm involves significantly less data scoring and graphing than the version used in the Standard arm.
Intervention Type
Behavioral
Intervention Name(s)
Standard FA+FCT
Intervention Description
Standard Functional Analysis and Functional Communication Training
Intervention Type
Behavioral
Intervention Name(s)
Pragmatic FA+FCT
Intervention Description
Pragmatic Functional Analysis and Functional Communication Training
Primary Outcome Measure Information:
Title
Percent Reduction in Problem Behavior
Description
Rate of problem behavior (destruction, aggression, self-injury, noncompliance, etc.) is computed by scoring the frequency of these target behaviors during observation sessions completed before treatment and at the end of treatment.
Time Frame
Change from Baseline to End of Treatment (typically within 4-6 mos.)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
83 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed diagnosis of autism spectrum disorder Significant behavior problems requiring treatment At least one parent willing to be trained in behavior analysis via telehealth Exclusion Criteria: Unstable or degenerative neurological disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew J O'Brien, PhD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data for individual participants will be made available through the National Database for Autism Research (NDAR) using the access tools and procedures implemented within NDAR. NDAR is one of the databases that is part of the NIMH Data Archive.
IPD Sharing Time Frame
Descriptive data will be available as soon as the study has been completed and data have been entered in NDAR. Experimental data will not be available until all treatment and follow-up data have been completed and the initial publications for the study have been published.
IPD Sharing Access Criteria
Access criteria are established by NDAR. Additional information about data access for scientists can be obtained at the URL listed below.
IPD Sharing URL
https://nda.nih.gov/

Learn more about this trial

Comparing Behavioral Assessments Using Telehealth for Children With Autism

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