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T-ABA Group Based Early Intervention For Parents of Children With ASD (T-ABA)

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ClinicalTrials.gov Identifier: NCT02202421
Recruitment Status : Terminated (PI and study coordinator both left the institution.)
First Posted : July 29, 2014
Last Update Posted : October 24, 2017
Sponsor:
Collaborators:
O'Neill Foundation
CVS Caremark
Information provided by (Responsible Party):
The Cleveland Clinic

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Autism Behavioral: Targeted Applied Behavior Analysis (T-ABA) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Targeted Applied Behavior Analysis (T-ABA) Group Based Early Intervention for Parents of Children With Autism Spectrum Disorder (ASD)
Study Start Date : January 2015
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: T-ABA Parent Training Only
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.
Behavioral: 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.

Experimental: T-ABA Parent Group + Individual Therapy
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.
Behavioral: 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Child communication [ Time Frame: 10 weeks ]
    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.

  2. Autism and other behavioral symptoms [ Time Frame: 10 weeks ]
    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.

  3. Language Scores [ Time Frame: 10 weeks ]
    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.

  4. Adaptive Behavior [ Time Frame: 10 weeks ]
    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.

  5. Eye Tracking [ Time Frame: 10 weeks ]
    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.

  6. Global Functioning [ Time Frame: 10 weeks ]
    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.

  7. Quality of Life [ Time Frame: 10 weeks ]
    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.


Other Outcome Measures:
  1. Demographics and Clinical Variables [ Time Frame: 10 weeks ]
    To evaluate whether baseline demographic and clinical variables (age, sex, IQ, parent education, parent occupation level, presence of a genetic syndrome) significantly predict patient outcomes.

  2. Parent Fidelity [ Time Frame: 10 weeks ]
    To assess if parent fidelity of T-ABA treatment predicts greater improvement in outcomes.

  3. Parent Education [ Time Frame: 10 weeks ]
    To evaluate parents' increased understanding of autism and strategies to manage their child's behavior, evaluated by a pre-/post-test regarding autism and therapeutic options.



Information from the National Library of Medicine

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Ages Eligible for Study:   24 Months to 71 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02202421


Locations
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United States, Ohio
Cleveland Clinic Center for Autism
Cleveland, Ohio, United States, 44104
Sponsors and Collaborators
The Cleveland Clinic
O'Neill Foundation
CVS Caremark
Investigators
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Principal Investigator: Thomas W Frazier, PhD Cleveland Clinic Center for Autism

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.

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Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02202421     History of Changes
Other Study ID Numbers: CCF IRB 14-429
First Posted: July 29, 2014    Key Record Dates
Last Update Posted: October 24, 2017
Last Verified: October 2017

Keywords provided by The Cleveland Clinic:
Autism
Applied Behavior Analysis

Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders