Comparing Behavioral Assessments Using Telehealth for Children With Autism

Autism Spectrum Disorder Clinical Trial

Official title:

Comparing Behavioral Assessments Using Telehealth for Children With Autism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02456298
• Other study ID #: IRB#201501781
• Secondary ID: R01MH104363
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: May 31, 2020

Study information

• Verified date: October 2020
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months to 83 Months

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Behavioral:
• Standard FA+FCT
Standard Functional Analysis and Functional Communication Training
• Pragmatic FA+FCT
Pragmatic Functional Analysis and Functional Communication Training

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa

Sponsors (5)

Lead Sponsor	Collaborator
Matthew J O'Brien, PhD, BCBA-D	Children's Healthcare of Atlanta, Emory University, National Institute of Mental Health (NIMH), University of Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from Baseline to End of Treatment (typically within 4-6 mos.)