Autism Spectrum DisorderNCT02339935
Improving Hospitalizations for Children With ASD
A study testing Brief Analogue Functional Analysis and No Brief AFA in people with Autism Spectrum Disorder and Autistic Disorder, run by Vanderbilt University at 1 site in United States.
Trial summary
This study aims to implement and test a specific brief Applied Behavior Analysis model for assessing and responding to severe challenging behavior during acute medical and behavioral hospitalization for children with ASD. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Autism Spectrum Disorder, Autistic Disorder
- What is being tested?
- Brief Analogue Functional Analysis and No Brief AFA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Nov 2015
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- documented diagnosis of an ASD based on clinical DSM-5 diagnostic criteria assessed by attending psychiatrist
- the presence of a significant challenging behaviors (e.g., aggression, property destruction, self-injury, elopement)
- admission to the VPH or medical floors
- individual and caregiver agreement to participate and ability to provide informed consent (and assent).
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center - MEND Clinic
Nashville, Tennessee, 37212
About this study
Official title: Improving Hospitalizations for Children With ASD: Testing the Cost and Clinical Efficacy of Integrated Behavioral Intervention
This study aims to implement and test a specific brief Applied Behavior Analysis model for assessing and responding to severe challenging behavior during acute medical and behavioral hospitalization for children with ASD. The investigators will evaluate the impact of this program by conducting a randomized trial across both medical and psychiatric hospital settings.
- Conditions
- Autism Spectrum Disorder, Autistic Disorder
- Being tested
- Brief Analogue Functional Analysis, No Brief AFA
- Keywords
- Autism Spectrum Disorder, Autism
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Analogue Functional AnalysisBehavioural
The Brief AFA seeks to identify the function of the challenging behavior by creating controlled test conditions in which specific responses are provided for challenging behavior (e.g., attention, escape from task demands, access to tangible - including variants of each as needed), as well as a control condition in which continual access to attention and preferred items is provided. It consists of a 30-90-minute abbreviated analysis comprised of a single exposure to 2-5-minute test and control conditions, along with replication of applicable test conditions and a treatment probe, which provides evidence of challenging behavior function faster than other methods.
No Brief AFAOther
These participants will receive typical standard of care procedures while hospitalized, but will not receive the additional behavioral intervention
| Study group | Role | What they receive |
|---|---|---|
| ABA Treatment Group | Experimental | 20 Children - 10 hospitalized at Vanderbilt Children's Hospital and 10 hospitalized at Vanderbilt Psychiatric hospital - will receive Brief Analogue Functional Analysis (Brief AFA) targeted to their most problematic behavior(s) while hospitalized Receives: Behavioral: Brief Analogue Functional Analysis |
| Control Group | Other | 20 Children - 10 hospitalized at Vanderbilt Children's Hospital and 10 hospitalized at Vanderbilt Psychiatric hospital - will receive all typical standard of care procedures while hospitalized, but will not receive Brief AFA Receives: Other: No Brief AFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aberrant Behavior Checklist
The ABC is a well-validated measure designed to assess for the presence of clinically significant challenging behavior in the areas of irritability and agitation, lethargy and social withdrawal, stereotypic behavior, hyperactivity and noncompliance, and inappropriate speech.
Measured: Change from Baseline ABC at Hospital Discharge (an expected average of 42 days) and 3-Months Post-Discharge
Decrease in Length of Hospitalization
Reduction in the days hospitalized past medical clearance).
Measured: Participants will be followed from admission to discharge, an expected average of 42 days
Secondary outcomes (3)
Clinical Global Impression Scales of Severity
Attending physician's impressions of participant's clinical impairment and improvement.
Measured: Baseline and Day of Patient's Discharge (an expected average of 42 days from admission)
Blinded Observational Ratings
Blinded coding of the challenging behaviors targeted in the treatment arm
Measured: Participants will be followed for duration of hospital stay, an expected average of 42 days
Physician/Nurse/Family Perception of Care
The primary medical attending, lead discharge nurse staff member, and the child's primary parent will also be asked at discharge to provide both quantitative and qualitative ratings of challenges and successes during hospitalization. Caregivers will be contacted to complete a simple interview/questionnaire 3- months post-hospitalization regarding changes in the patient's medication, medical conditions, residential/classroom placement, emergency room visits or psychiatric hospitalizations since the discharge date, as well as ratings of successes implementing components of the behavioral strategies plan utilized during the hospitalization (if applicable).
Measured: Day of Patient's Discharge (an expected average of 42 days from admission)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Sanders, Vanderbilt University
- Investigators
- Kevin Sanders, MD, Principal investigator, MEND Clinic - Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02339935
- Sponsor's protocol ID
- 141265
- Status last verified
- Sep 2015
- First submitted
- 30 Dec 2014
- Last updated
- 27 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Sanders K, Staubitz J, Juarez AP, Marler S, Browning W, McDonnell E, Altstein L, Macklin EA, Warren Z. Addressing Challenging Behavior During Hospitalizations for Children with Autism: A Pilot Applied Behavior Analysis Randomized Controlled Trial. Autism Res. 2020 Jul;13(7):1072-1078. doi: 10.1002/aur.2308. Epub 2020 Apr 23.
PubMed 32329237
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Hospitalizations for Children With ASD: Testing the Cost and Clinical Efficacy of Integrated Behavioral Intervention
- ClinicalTrials.gov ID
- NCT02339935
- Acronym / sponsor ID
- 141265
- Conditions
- Autism Spectrum Disorder, Autistic Disorder
- Keywords
- Autism Spectrum Disorder, Autism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 16 Jan 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.
This study aims to implement and test a specific brief Applied Behavior Analysis model for assessing and responding to severe challenging behavior during acute medical and behavioral hospitalization for children with ASD. The investigators will evaluate the impact of this program by conducting a randomized trial across both medical and psychiatric hospital settings.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABA Treatment Group | Experimental | Behavioral: Brief Analogue Functional Analysis20 Children - 10 hospitalized at Vanderbilt Children's Hospital and 10 hospitalized at Vanderbilt Psychiatric hospital - will receive Brief Analogue Functional Analysis (Brief AFA) targeted to their most problematic behavior(s) while hospitalized |
| Control Group | Other | Other: No Brief AFA20 Children - 10 hospitalized at Vanderbilt Children's Hospital and 10 hospitalized at Vanderbilt Psychiatric hospital - will receive all typical standard of care procedures while hospitalized, but will not receive Brief AFA |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- documented diagnosis of an ASD based on clinical DSM-5 diagnostic criteria assessed by attending psychiatrist
- the presence of a significant challenging behaviors (e.g., aggression, property destruction, self-injury, elopement)
- admission to the VPH or medical floors
- individual and caregiver agreement to participate and ability to provide informed consent (and assent).
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Brief Analogue Functional AnalysisThe Brief AFA seeks to identify the function of the challenging behavior by creating controlled test conditions in which specific responses are provided for challenging behavior (e.g., attention, escape from task demands, access to tangible - including variants of each as needed), as well as a control condition in which continual access to attention and preferred items is provided. It consists of a 30-90-minute abbreviated analysis comprised of a single exposure to 2-5-minute test and control conditions, along with replication of applicable test conditions and a treatment probe, which provides evidence of challenging behavior function faster than other methods. | Behavioural | ABA Treatment Group |
| No Brief AFAThese participants will receive typical standard of care procedures while hospitalized, but will not receive the additional behavioral intervention | Other | Control Group |
Primary outcome
Aberrant Behavior Checklist
Time frame: Change from Baseline ABC at Hospital Discharge (an expected average of 42 days) and 3-Months Post-Discharge
The ABC is a well-validated measure designed to assess for the presence of clinically significant challenging behavior in the areas of irritability and agitation, lethargy and social withdrawal, stereotypic behavior, hyperactivity and noncompliance, and inappropriate speech.
Decrease in Length of Hospitalization
Time frame: Participants will be followed from admission to discharge, an expected average of 42 days
Reduction in the days hospitalized past medical clearance).
3 secondary outcomes
Clinical Global Impression Scales of Severity
Time frame: Baseline and Day of Patient's Discharge (an expected average of 42 days from admission)
Blinded Observational Ratings
Time frame: Participants will be followed for duration of hospital stay, an expected average of 42 days
Physician/Nurse/Family Perception of Care
Time frame: Day of Patient's Discharge (an expected average of 42 days from admission)
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 27 Apr 2016.
- Derived from this study: PubMed 32329237Sanders K, Staubitz J, Juarez AP, Marler S, Browning W, McDonnell E, Altstein L, Macklin EA, Warren Z. Addressing Challenging Behavior During Hospitalizations for Children with Autism: A Pilot Applied Behavior Analysis Randomized Controlled Trial. Autism Res. 2020 Jul;13(7):1072-1078. doi: 10.1002/aur.2308. Epub 2020 Apr 23.
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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.
Kevin Sanders, MD principal investigator
MEND Clinic - Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Analogue Functional Analysis and No Brief AFA in people with Autism Spectrum Disorder and Autistic Disorder, run by Vanderbilt University 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 4 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 27 Apr 2016. 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?
Aberrant Behavior Checklist (time frame: Change from Baseline ABC at Hospital Discharge (an expected average of 42 days) and 3-Months Post-Discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02339935, which also lists 1 linked publication.
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 27 Apr 2016.