Autism Spectrum DisorderNCT02456298
Comparing Behavioral Assessments Using Telehealth for Children With Autism
A study testing Standard FA+FCT and Pragmatic FA+FCT in people with Autism Spectrum Disorder, run by Matthew J O'Brien, PhD, BCBA-D at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 83 months
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Standard FA+FCT and Pragmatic FA+FCT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to 31 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 83 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Confirmed diagnosis of autism spectrum disorder
- Significant behavior problems requiring treatment
- At least one parent willing to be trained in behavior analysis via telehealth
Who cannot join
- Unstable or degenerative neurological disorder
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Standard FA+FCT, Pragmatic FA+FCT
- Keywords
- Telehealth, Applied behavior analysis
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard FA+FCTBehavioural
Standard Functional Analysis and Functional Communication Training
Pragmatic FA+FCTBehavioural
Pragmatic Functional Analysis and Functional Communication Training
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Pragmatic FA+FCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline to End of Treatment (typically within 4-6 mos.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2015 (estimated)
- Study startJun 2015
- Primary completion31 May 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Matthew J O'Brien, PhD, BCBA-D
- Sponsor type
- University, hospital or other
- Collaborators
- University of Houston, Emory University, Children's Healthcare of Atlanta, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor-investigator, Matthew J O'Brien, PhD, BCBA-D, University of Iowa
- Investigators
- Matthew J O'Brien, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02456298
- Sponsor's protocol ID
- IRB#201501781
- Other IDs
- R01MH104363
- Status last verified
- Oct 2020
- First submitted
- 26 May 2015
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Behavioral Assessments Using Telehealth for Children With Autism
- ClinicalTrials.gov ID
- NCT02456298
- Acronym / sponsor ID
- IRB#201501781
- Conditions
- Autism Spectrum Disorder
- Keywords
- Telehealth, Applied behavior analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Matthew J O'Brien, PhD, BCBA-DUniversity, hospital or other
- Collaborators
- University of Houston, Emory University, Children's Healthcare of Atlanta, National Institute of Mental Health (NIMH)
- Study start
- Jun 2015
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 28 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard FA+FCT | Active comparator | Behavioral: Standard FA+FCTParents 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. |
| Pragmatic FA+FCT | Experimental | Behavioral: Pragmatic FA+FCTParents 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. |
Who may qualify
- Ages
- 18 to 83 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Confirmed diagnosis of autism spectrum disorder
- Significant behavior problems requiring treatment
- At least one parent willing to be trained in behavior analysis via telehealth
Key exclusion criteria (1 listed)
- Unstable or degenerative neurological disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard FA+FCTStandard Functional Analysis and Functional Communication Training | Behavioural | Standard FA+FCT |
| Pragmatic FA+FCTPragmatic Functional Analysis and Functional Communication Training | Behavioural | Pragmatic FA+FCT |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Autism Spectrum Disorder
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew J O'Brien, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard FA+FCT and Pragmatic FA+FCT in people with Autism Spectrum Disorder, run by Matthew J O'Brien, PhD, BCBA-D at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Reduction in Problem Behavior (time frame: Change from Baseline to End of Treatment (typically within 4-6 mos.)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.