AutismT-ABANCT02202421
T-ABA Group Based Early Intervention For Parents of Children With ASD
A study testing Targeted Applied Behavior Analysis (T-ABA) in people with Autism, run by The Cleveland Clinic at 1 site in United States.
Trial summary
This study is a 10-week, randomized, parallel groups design which will evaluate the efficacy of T-ABA with combined parent training and individual child sessions versus T-ABA with individual sessions alone. Read more about this study
- Who is it for?
- Ages 24 to 71 months
- Conditions the study is for
- Autism
- What is being tested?
- Targeted Applied Behavior Analysis (T-ABA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Apr 2017
- 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 24 to 71 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical DSM-5 diagnosis of Autism Spectrum Disorder (299.00).
- Age 2.0 (24 months) to 5.99 (71 months) at time of consent.
- If participant is using neuropsychiatric medication and/or receiving therapy (PT, OT, speech, ABA, etc.), these must be stable two weeks prior to their study participation and throughout the 10 week study period.
Who cannot join
- Age less than 2.0 (24 months) or greater than 5.99 (71 months) at time of consent.
- Individuals for whom neuropsychiatric medication (dose, dosing schedule, introduction of new medication, discontinuing current medication) or therapy (frequency of intervention, provider, introduction of new therapy, discontinuing current therapy) changes may occur two weeks prior to study or during the 10 week study period.
- Any participant who has previously received Applied Behavior Analysis (ABA) therapy (any form).
- Parent and/or guardian unable to speak, read and/or understand English.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Center for Autism
Cleveland, Ohio, 44104
About this study
Official title: Targeted Applied Behavior Analysis (T-ABA) Group Based Early Intervention for Parents of Children With Autism Spectrum Disorder (ASD)
This study is a 10-week, randomized, parallel groups design which will evaluate the efficacy of T-ABA with combined parent training and individual child sessions versus T-ABA with individual sessions alone. T-ABA refers to Targeted Applied Behavior Analysis treatment, a form of behavior therapy used to promote skill development and reduce disruptive behavior in individuals with autism. Four key outcome assessment points will be used: baseline (week 0), midpoint (week 5), end-of-study (week 10), and follow-up (week 20). Participants receiving T-ABA parent training only will be offered eight individual therapy sessions at the end of the study. Total study participation is estimated to be ~ 10 weeks with a single follow-up assessment.
Read the detailed description
This is a ten week study. The child will be randomized to one of two treatment groups. Assignment is chosen by chance (like flipping a coin). The two treatment groups are T-ABA (Targeted Applied Behavior Analysis) with parent training and T-ABA with parent training and individual child sessions. For both groups, study procedures will be the same except the T-ABA with parent training and individual child sessions group will receive eight one-to-one Applied Behavior Analysis (ABA) individual therapy sessions during the course of the study. Participants in the T-ABA with parent training group will be offered eight one-to-one ABA individual therapy sessions at the conclusion of the study.
During the child's participation in this study families are asked to not make any changes to his or her current neuropsychiatric medications or therapy for two weeks before the study begins and during his or her ten week participation. Medication changes may include increasing or decreasing the dose you receive, changing the time of day the child takes medication, starting a new medication, or discontinuing a current medication. Therapy the child receives may include speech, OT, PT, counseling, play therapy, music therapy, social skills training, special education services, socialization, recreational sports, or nutritional interventions. Therapy changes may include increasing or decreasing how often the child receives therapy, changing who the child receives therapy from, beginning a new therapy or discontinuing a current therapy.
The child will be asked to complete assessments before the start of the study. The child will complete a language assessment and an eye tracking task that will measure his or her attention to different pictures and videos. Families will complete questionnaires that examine the child's medical and family history as well as his or her current symptoms, functioning, and quality of life and families will be given a language collection device. This is like a recorder that will record every time the family or the child talks. Families will place the language collection device in the pocket of the child's clothing and it will record the language environment for two days. Families will return the language collection device to us. To help us better understand your child's medical condition, we will access the child's medical records to collect any previous evaluations and diagnoses.
During weeks 1 through 4, families will attend a parent training group. Each group will be 1.5 hours long and will focus on topics such as discrete trial teaching (breaking skills into small components in order to teach new information to the child), natural environment teaching (using the environment to increase the child's motivation to communicate), assessing and treating challenging behavior, using visual supports and teaching everyday living activities such as drinking from a cup or washing hands. During these groups families will have the opportunity to view examples and practice using the skills discussed.
During week 5, families will attend a parent training group. Families and their children will also be observed and videotaped by study staff for 10 minutes during which they will be asked to use the techniques you learned during the parent group. The video tape will be kept in the child's study file and will only be viewed by study staff as part of the research study. Families will also complete questionnaires that examine the child's medical and family history as well as his or her current symptoms, functioning, and quality of life and will be given a language collection device (like a tape recorder). They will place the language collection device in the pocket of the child's clothing and it will record his or her language and language environment for 2 days. They will return the language collection device to us.
During weeks 6 through 9 families and their children will attend a one-hour weekly parent-therapist session with a study staff member. They will practice using the techniques from the parent group with their child and the study staff member will provide them with coaching and feedback. Families can also bring along specific questions they have.
During week 10, families will attend a parent-therapist session. Families and their children will also be observed and videotaped by study staff for 10 minutes during which they will practice using the techniques from the parent group with their child. They will also complete questionnaires that examine the child's current symptoms, functioning, and quality of life and they will be given a language collection device. They will place the language collection device in the pocket of the child's clothing and it will record his or her language and language environment for 2 days. Families will return the language collection device to us. The child will also complete testing with a study staff. Testing will measure the child's language and attention to pictures and videos during an eye tracking task.
Ten weeks after the study is complete, families and their children will complete the same assessment procedures that were completed during week 10 in order to measure any changes that occurred after the end of the study.
If a family is in the T-ABA with parent training and individual child sessions group, the child will also receive one-to-one ABA therapy sessions during weeks 1 through 4 and 6 through 9. During the one-to-one ABA therapy sessions the child may work with the therapist on skills such as making eye contact when his or her name is called, playing with toys, asking for favorite foods or activities using words or gestures, making choices, taking turns or responding to one-step commands. Study staff will work with families to select programming to be completed with their child during these sessions.
If a family is in the T-ABA with parent training group, they will be asked if they'd like to schedule eight one-to-one ABA therapy sessions at the conclusion of the study (after follow-up assessments have been collected).
Families will receive assessment results in a brief report provided after testing is completed at visits 1, 5, 10 and follow up.
- Conditions
- Autism
- Being tested
- Targeted Applied Behavior Analysis (T-ABA)
- Keywords
- Autism, Applied Behavior Analysis
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted Applied Behavior Analysis (T-ABA)Behavioural
Participants will be enrolled in a five week Targeted Applied Behavior Analysis (T-ABA) parent therapy group. T-ABA parent groups will be 1.5 hours in length. Following the five weeks of parent group sessions, parents will participate in five weekly one-hour parent-therapist sessions in which a therapist will work one-on-one with the parent and their child. One treatment group (T-ABA Parent Group plus Individual Therapy) will also receive eight one-hour individual therapist-child applied behavior analysis therapy sessions concurrent with the parent group and parent-therapist sessions. The second treatment group (T-ABA Parent Training Only) will be offered eight one hour individual therapist-child applied behavior analysis sessions at the conclusion of the study if desired.
| Study group | Role | What they receive |
|---|---|---|
| T-ABA Parent Training Only | Active comparator | Participants in the T-ABA Parent Training Only group will be given Targeted Applied Behavior Analysis (T-ABA) Intervention with five weeks of parent group training and five weeks of parent-therapists one-on-one sessions. They will also be offered eight one hour individual therapist-child applied behavior analysis sessions at the conclusion of the study if desired. Receives: Behavioral: Targeted Applied Behavior Analysis (T-ABA) |
| T-ABA Parent Group + Individual Therapy | Experimental | Participants in the T-ABA Parent Group plus Individual Therapy group will be given Targeted Applied Behavior Analysis (T-ABA) Intervention with five weeks of parent group training and five weeks of parent-therapists one-on-one sessions. They will also be offered eight one-hour individual therapist-child applied behavior analysis therapy sessions concurrent with the parent group and parent-therapist sessions. Receives: Behavioral: Targeted Applied Behavior Analysis (T-ABA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in child utterances
The primary objective of this study is to determine whether T-ABA with parent training and individual child sessions is superior to T-ABA with parent training alone in improving child utterances as calculated by the LENA digital language processor.
Measured: 10 weeks
Secondary outcomes (7)
Child communication
To evaluate if T-ABA with combined child sessions and parent training is superior to T-ABA with parent training alone in increasing the number of child utterances as measured using the LENA Pro language collection device.
Measured: 10 weeks
Autism and other behavioral symptoms
To evaluate if T-ABA with combined child sessions and parent training is superior to T-ABA with parent training alone in improving autism and other behavioral symptoms.
Measured: 10 weeks
Language Scores
To evaluate if T-ABA with combined child sessions and parent training is superior to T-ABA with parent training alone in improving language scores on cognitive testing.
Measured: 10 weeks
Adaptive Behavior
To evaluate if T-ABA with combined child sessions and parent training is superior to T-ABA with parent training alone in improving adaptive behavior.
Measured: 10 weeks
Eye Tracking
To evaluate if T-ABA with combined child sessions and parent training is superior to T-ABA with parent training alone in improving eye tracking of social targets.
Measured: 10 weeks
Global Functioning
To evaluate if T-ABA with combined child sessions and parent training is superior to T-ABA with parent training alone in improving global functioning via VB-MAPP.
Measured: 10 weeks
Quality of Life
To evaluate if T-ABA with combined child sessions and parent training is superior to T-ABA with parent training alone in improving quality of life.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2014 (estimated)
- Study startJan 2015
- Primary completionApr 2017
- Study completionApr 2017
Why it stopped: PI and study coordinator both left the institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- O'Neill Foundation, CVS Caremark
- Responsible party
- Sponsor
- Investigators
- Thomas W Frazier, PhD, Principal investigator, Cleveland Clinic Center for Autism
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02202421
- Sponsor's protocol ID
- CCF IRB 14-429
- Acronym
- T-ABA
- Status last verified
- Oct 2017
- First submitted
- 22 Jul 2014
- Last updated
- 24 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. Fifth ed. Arlington, VA: American Psychiatric Association; 2013.
Kohler, F.W. Examining the services received by young children with autism and their families: A survey of parent responses. Focus on Autism and Other Developmental Disabilities. 1999;14:150-158.
Stoner JB, Bock SJ, Thompson JR, Angell ME, Heyl BS, Crowley EP. Welcome to our world: Parent perceptions of interactions between parents of young children with ASD and educational professionals. Focus on Autism and Other Developmental Disabilities. 2005;20:39-51.
Kogan MD, Strickland BB, Blumberg SJ, Singh GK, Perrin JM, van Dyck PC. A national profile of the health care experiences and family impact of autism spectrum disorder among children in the United States, 2005-2006. Pediatrics. 2008 Dec;122(6):e1149-58. doi: 10.1542/peds.2008-1057.
PubMed 19047216Minjarez MB, Williams SE, Mercier EM, Hardan AY. Pivotal response group treatment program for parents of children with autism. J Autism Dev Disord. 2011 Jan;41(1):92-101. doi: 10.1007/s10803-010-1027-6.
PubMed 20440638Coolican J, Smith IM, Bryson SE. Brief parent training in pivotal response treatment for preschoolers with autism. J Child Psychol Psychiatry. 2010 Dec;51(12):1321-30. doi: 10.1111/j.1469-7610.2010.02326.x.
PubMed 21073457
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Applied Behavior Analysis (T-ABA) Group Based Early Intervention for Parents of Children With Autism Spectrum Disorder (ASD)
- ClinicalTrials.gov ID
- NCT02202421
- Acronym / sponsor ID
- T-ABA / CCF IRB 14-429
- Conditions
- Autism
- Keywords
- Autism, Applied Behavior Analysis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI and study coordinator both left the institution.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- O'Neill Foundation, CVS Caremark
- Study start
- Jan 2015
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 29 Jul 2014 (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 is a 10-week, randomized, parallel groups design which will evaluate the efficacy of T-ABA with combined parent training and individual child sessions versus T-ABA with individual sessions alone. T-ABA refers to Targeted Applied Behavior Analysis treatment, a form of behavior therapy used to promote skill development and reduce disruptive behavior in individuals with autism. Four key outcome assessment points will be used: baseline (week 0), midpoint (week 5), end-of-study (week 10), and follow-up (week 20). Participants receiving T-ABA parent training only will be offered eight individual therapy sessions at the end of the study. Total study participation is estimated to be ~ 10 weeks with a single follow-up assessment.
Detailed description
This is a ten week study. The child will be randomized to one of two treatment groups. Assignment is chosen by chance (like flipping a coin). The two treatment groups are T-ABA (Targeted Applied Behavior Analysis) with parent training and T-ABA with parent training and individual child sessions. For both groups, study procedures will be the same except the T-ABA with parent training and individual child sessions group will receive eight one-to-one Applied Behavior Analysis (ABA) individual therapy sessions during the course of the study. Participants in the T-ABA with parent training group will be offered eight one-to-one ABA individual therapy sessions at the conclusion of the study.
During the child's participation in this study families are asked to not make any changes to his or her current neuropsychiatric medications or therapy for two weeks before the study begins and during his or her ten week participation. Medication changes may include increasing or decreasing the dose you receive, changing the time of day the child takes medication, starting a new medication, or discontinuing a current medication. Therapy the child receives may include speech, OT, PT, counseling, play therapy, music therapy, social skills training, special education services, socialization, recreational sports, or nutritional interventions. Therapy changes may include increasing or decreasing how often the child receives therapy, changing who the child receives therapy from, beginning a new therapy or discontinuing a current therapy.
The child will be asked to complete assessments before the start of the study. The child will complete a language assessment and an eye tracking task that will measure his or her attention to different pictures and videos. Families will complete questionnaires that examine the child's medical and family history as well as his or her current symptoms, functioning, and quality of life and families will be given a language collection device. This is like a recorder that will record every time the family or the child talks. Families will place the language collection device in the pocket of the child's clothing and it will record the language environment for two days. Families will return the language collection device to us. To help us better understand your child's medical condition, we will access the child's medical records to collect any previous evaluations and diagnoses.
During weeks 1 through 4, families will attend a parent training group. Each group will be 1.5 hours long and will focus on topics such as discrete trial teaching (breaking skills into small components in order to teach new information to the child), natural environment teaching (using the environment to increase the child's motivation to communicate), assessing and treating challenging behavior, using visual supports and teaching everyday living activities such as drinking from a cup or washing hands. During these groups families will have the opportunity to view examples and practice using the skills discussed.
During week 5, families will attend a parent training group. Families and their children will also be observed and videotaped by study staff for 10 minutes during which they will be asked to use the techniques you learned during the parent group. The video tape will be kept in the child's study file and will only be viewed by study staff as part of the research study. Families will also complete questionnaires that examine the child's medical and family history as well as his or her current symptoms, functioning, and quality of life and will be given a language collection device (like a tape recorder). They will place the language collection device in the pocket of the child's clothing and it will record his or her language and language environment for 2 days. They will return the language collection device to us.
During weeks 6 through 9 families and their children will attend a one-hour weekly parent-therapist session with a study staff member. They will practice using the techniques from the parent group with their child and the study staff member will provide them with coaching and feedback. Families can also bring along specific questions they have.
During week 10, families will attend a parent-therapist session. Families and their children will also be observed and videotaped by study staff for 10 minutes during which they will practice using the techniques from the parent group with their child. They will also complete questionnaires that examine the child's current symptoms, functioning, and quality of life and they will be given a language collection device. They will place the language collection device in the pocket of the child's clothing and it will record his or her language and language environment for 2 days. Families will return the language collection device to us. The child will also complete testing with a study staff. Testing will measure the child's language and attention to pictures and videos during an eye tracking task.
Ten weeks after the study is complete, families and their children will complete the same assessment procedures that were completed during week 10 in order to measure any changes that occurred after the end of the study.
If a family is in the T-ABA with parent training and individual child sessions group, the child will also receive one-to-one ABA therapy sessions during weeks 1 through 4 and 6 through 9. During the one-to-one ABA therapy sessions the child may work with the therapist on skills such as making eye contact when his or her name is called, playing with toys, asking for favorite foods or activities using words or gestures, making choices, taking turns or responding to one-step commands. Study staff will work with families to select programming to be completed with their child during these sessions.
If a family is in the T-ABA with parent training group, they will be asked if they'd like to schedule eight one-to-one ABA therapy sessions at the conclusion of the study (after follow-up assessments have been collected).
Families will receive assessment results in a brief report provided after testing is completed at visits 1, 5, 10 and follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T-ABA Parent Training Only | Active comparator | Behavioral: Targeted Applied Behavior Analysis (T-ABA)Participants in the T-ABA Parent Training Only group will be given Targeted Applied Behavior Analysis (T-ABA) Intervention with five weeks of parent group training and five weeks of parent-therapists one-on-one sessions. They will also be offered eight one hour individual therapist-child applied behavior analysis sessions at the conclusion of the study if desired. |
| T-ABA Parent Group + Individual Therapy | Experimental | Behavioral: Targeted Applied Behavior Analysis (T-ABA)Participants in the T-ABA Parent Group plus Individual Therapy group will be given Targeted Applied Behavior Analysis (T-ABA) Intervention with five weeks of parent group training and five weeks of parent-therapists one-on-one sessions. They will also be offered eight one-hour individual therapist-child applied behavior analysis therapy sessions concurrent with the parent group and parent-therapist sessions. |
Who may qualify
- Ages
- 24 to 71 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Clinical DSM-5 diagnosis of Autism Spectrum Disorder (299.00).
- Age 2.0 (24 months) to 5.99 (71 months) at time of consent.
- If participant is using neuropsychiatric medication and/or receiving therapy (PT, OT, speech, ABA, etc.), these must be stable two weeks prior to their study participation and throughout the 10 week study period.
Key exclusion criteria (4 listed)
- Age less than 2.0 (24 months) or greater than 5.99 (71 months) at time of consent.
- Individuals for whom neuropsychiatric medication (dose, dosing schedule, introduction of new medication, discontinuing current medication) or therapy (frequency of intervention, provider, introduction of new therapy, discontinuing current therapy) changes may occur two weeks prior to study or during the 10 week study period.
- Any participant who has previously received Applied Behavior Analysis (ABA) therapy (any form).
- Parent and/or guardian unable to speak, read and/or understand English.
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 |
|---|---|---|
| Targeted Applied Behavior Analysis (T-ABA)Participants will be enrolled in a five week Targeted Applied Behavior Analysis (T-ABA) parent therapy group. T-ABA parent groups will be 1.5 hours in length. Following the five weeks of parent group sessions, parents will participate in five weekly one-hour parent-therapist sessions in which a therapist will work one-on-one with the parent and their child. One treatment group (T-ABA Parent Group plus Individual Therapy) will also receive eight one-hour individual therapist-child applied behavior analysis therapy sessions concurrent with the parent group and parent-therapist sessions. The second treatment group (T-ABA Parent Training Only) will be offered eight one hour individual therapist-child applied behavior analysis sessions at the conclusion of the study if desired. | Behavioural | T-ABA Parent Group + Individual Therapy, T-ABA Parent Training Only |
Primary outcome
Increase in child utterances
Time frame: 10 weeks
The primary objective of this study is to determine whether T-ABA with parent training and individual child sessions is superior to T-ABA with parent training alone in improving child utterances as calculated by the LENA digital language processor.
7 secondary outcomes
Child communication
Time frame: 10 weeks
Autism and other behavioral symptoms
Time frame: 10 weeks
Language Scores
Time frame: 10 weeks
Adaptive Behavior
Time frame: 10 weeks
Eye Tracking
Time frame: 10 weeks
Global Functioning
Time frame: 10 weeks
Quality of Life
Time frame: 10 weeks
Results and safety
The study was stopped early (reason given: PI and study coordinator both left the institution.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2017.
- BackgroundAmerican Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. Fifth ed. Arlington, VA: American Psychiatric Association; 2013.
- BackgroundKohler, F.W. Examining the services received by young children with autism and their families: A survey of parent responses. Focus on Autism and Other Developmental Disabilities. 1999;14:150-158.
- BackgroundStoner JB, Bock SJ, Thompson JR, Angell ME, Heyl BS, Crowley EP. Welcome to our world: Parent perceptions of interactions between parents of young children with ASD and educational professionals. Focus on Autism and Other Developmental Disabilities. 2005;20:39-51.
- Background: PubMed 19047216Kogan MD, Strickland BB, Blumberg SJ, Singh GK, Perrin JM, van Dyck PC. A national profile of the health care experiences and family impact of autism spectrum disorder among children in the United States, 2005-2006. Pediatrics. 2008 Dec;122(6):e1149-58. doi: 10.1542/peds.2008-1057.
- Background: PubMed 20440638Minjarez MB, Williams SE, Mercier EM, Hardan AY. Pivotal response group treatment program for parents of children with autism. J Autism Dev Disord. 2011 Jan;41(1):92-101. doi: 10.1007/s10803-010-1027-6.
- Background: PubMed 21073457Coolican J, Smith IM, Bryson SE. Brief parent training in pivotal response treatment for preschoolers with autism. J Child Psychol Psychiatry. 2010 Dec;51(12):1321-30. doi: 10.1111/j.1469-7610.2010.02326.x.
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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.
Thomas W Frazier, PhD principal investigator
Cleveland Clinic Center for Autism
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted Applied Behavior Analysis (T-ABA) in people with Autism, run by The Cleveland Clinic 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 4 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: stopped early, as of the sponsor's last update on 24 Oct 2017. 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 was stopped early (reason given: PI and study coordinator both left the institution.). Results are not available in the source record.
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?
Increase in child utterances (time frame: 10 weeks). 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 NCT02202421, which also lists 6 linked publications.
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 24 Oct 2017.