Comparing Behavioral Assessments Using Telehealth for Children With Autism
|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: NCT02456298|
Recruitment Status : Recruiting
First Posted : May 28, 2015
Last Update Posted : December 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorder||Behavioral: Standard FA+FCT Behavioral: Pragmatic FA+FCT||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|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|
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
- 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.
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
|Contact: Scott D Lindgren, PhDfirstname.lastname@example.org|
|United States, Iowa|
|University of Iowa||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: Scott D Lindgren, PhD 319-353-6142 email@example.com|
|Principal Investigator:||Scott D Lindgren, PhD||University of Iowa|
|Principal Investigator:||Matthew J O'Brien, PhD||University of Iowa|