T-ABA Group Based Early Intervention For Parents of Children With ASD
| Status: | Terminated |
|---|---|
| Conditions: | Neurology, Psychiatric, Psychiatric, Autism |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 10/26/2017 |
| Start Date: | January 2015 |
| End Date: | April 2017 |
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.
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.
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.
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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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