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

NCT02202421 | Terminated

• 1 other identifier: CCF IRB 14-429
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism

Keywords

Autism; Applied Behavior Analysis

Outcome Measures

Primary Outcomes (1)

• 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.

  10 weeks

Secondary Outcomes (7)

• Child communication

  10 weeks

• Autism and other behavioral symptoms

  10 weeks

• Language Scores

  10 weeks

• Adaptive Behavior

  10 weeks

• Eye Tracking

  10 weeks

Other Outcomes (3)

• Demographics and Clinical Variables

  10 weeks

• Parent Fidelity

  10 weeks

• Parent Education

  10 weeks

Study Arms (2)

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.

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.

Behavioral: Targeted Applied Behavior Analysis (T-ABA)

Interventions

Targeted Applied Behavior Analysis (T-ABA) BEHAVIORAL

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.

T-ABA Parent Group + Individual Therapy; T-ABA Parent Training Only

Eligibility Criteria

• Age: 24 Months - 71 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• O'Neill Foundation: collaborator
• CVS Caremark: collaborator

Study Sites (1)

Cleveland Clinic Center for Autism

Cleveland, Ohio, 44104, United States

Location

Related Publications (6)

• American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. Fifth ed. Arlington, VA: American Psychiatric Association; 2013.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 19047216 BACKGROUND

• Minjarez 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.

  PMID: 20440638 BACKGROUND

• Coolican 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.

  PMID: 21073457 BACKGROUND

MeSH Terms

Conditions

Autistic Disorder

Interventions

tyrosine-4-azobenzenearsonate

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Thomas W Frazier, PhD

  Cleveland Clinic Center for Autism

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2014
• First Posted: July 29, 2014
• Study Start: January 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: October 24, 2017

Record last verified: 2017-10

Locations

US (1)