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Comparing Behavioral Assessments Using Telehealth for Children With Autism

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ClinicalTrials.gov Identifier: NCT02456298
Recruitment Status : Recruiting
First Posted : May 28, 2015
Last Update Posted : December 11, 2018
Sponsor:
Collaborators:
University of Houston - Clear Lake
Emory University
Children's Healthcare of Atlanta
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Scott D. Lindgren, University of Iowa

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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: Standard FA+FCT Behavioral: Pragmatic FA+FCT Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparing Behavioral Assessments Using Telehealth for Children With Autism
Study Start Date : June 2015
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard FA+FCT
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.
Behavioral: Standard FA+FCT
Standard Functional Analysis and Functional Communication Training

Experimental: Pragmatic FA+FCT
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.
Behavioral: Pragmatic FA+FCT
Pragmatic Functional Analysis and Functional Communication Training




Primary Outcome Measures :
  1. Percent Reduction in Problem Behavior [ Time Frame: Change from Baseline to End of Treatment (typically within 4-6 mos.) ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Months to 83 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT02456298


Contacts
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Contact: Scott D Lindgren, PhD 319-353-6142 scott-lindgren@uiowa.edu

Locations
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United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Scott D Lindgren, PhD    319-353-6142    scott-lindgren@uiowa.edu   
Sponsors and Collaborators
Scott D. Lindgren
University of Houston - Clear Lake
Emory University
Children's Healthcare of Atlanta
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Scott D Lindgren, PhD University of Iowa
Principal Investigator: Matthew J O'Brien, PhD University of Iowa

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Responsible Party: Scott D. Lindgren, Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT02456298     History of Changes
Other Study ID Numbers: IRB#201501781
R01MH104363 ( U.S. NIH Grant/Contract )
First Posted: May 28, 2015    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Clinical Study Report (CSR)
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.
Access Criteria: Access criteria are established by NDAR. Additional information about data access for scientists can be obtained at the URL listed below.
URL: https://ndar.nih.gov/learn_about_ndar_for_scientists.html

Keywords provided by Scott D. Lindgren, University of Iowa:
Telehealth
Applied behavior analysis

Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders