Comparing Behavioral Assessments Using Telehealth for Children With Autism

NCT02456298 | Completed DMC

• 2 other identifiers: IRB#201501781R01MH104363
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Keywords

Telehealth; Applied behavior analysis

Outcome Measures

Primary Outcomes (1)

• 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.)

Study Arms (2)

Standard FA+FCT

ACTIVE COMPARATOR

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

Pragmatic FA+FCT

EXPERIMENTAL

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

Interventions

Standard FA+FCT BEHAVIORAL

Standard Functional Analysis and Functional Communication Training

Standard FA+FCT

Pragmatic FA+FCT BEHAVIORAL

Pragmatic Functional Analysis and Functional Communication Training

Pragmatic FA+FCT

Eligibility Criteria

• Age: 18 Months - 83 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Unstable or degenerative neurological disorder

Sponsors & Collaborators

• Matthew J O'Brien, PhD, BCBA-D: lead
• University of Houston: collaborator
• Emory University: collaborator
• Children's Healthcare of Atlanta: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Matthew J O'Brien, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Psychologist/Assistant Professor

Study Record Dates

• First Submitted: May 26, 2015
• First Posted: May 28, 2015
• Study Start: June 1, 2015
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (1)