A Randomized Clinical Trial for Toddlers With ASD - Full Text View

Sponsor:	Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborator:	HRSA/Maternal and Child Health Bureau
Information provided by (Responsible Party):	Rebecca Landa, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
ClinicalTrials.gov Identifier:	NCT01008800

Purpose

This research is being done to test the effectiveness of two treatments aimed at increasing language and social skills in children with autism spectrum disorder. If children show improvement in these treatments, we hope that the availability of public services for minority and low income families will be increased. Minority and low income families with children between 22 and 33 months of age with Autism Spectrum Disorders may join.

Condition	Intervention
Autism Spectrum Disorder	Behavioral: Social Communication Behavioral: Social communication

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Parent-mediated vs Center-based Intervention for Toddlers With ASD: An RCT

Resource links provided by NLM:

MedlinePlus related topics: Autism

U.S. FDA Resources

Further study details as provided by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.:

Primary Outcome Measures:

Communication and Symbolic Behavior Scales [ Time Frame: immediately after treatment ends and 6 months after treatment ends ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mullen Scales of Early Learning [ Time Frame: immediately after treatment ends and 6 months after treatment ends ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	September 2009
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Center-Based classroom intervention Center-Based classroom intervention Four days a week for 2.5 hours a day the child will participate in a classroom with peers in an attempt to increase social communication, language abilities, and other skills. Parents will also receive education sessions 1-3 times per month for 1-2 hours each. Treatment will last for 6 months.	Behavioral: Social Communication Intervention in the Center-Based classroom intervention will be conducted at the Center for Autism and Related Disorders and focuses on providing children with an invigorating, motivating learning environment in which emerging skills and knowledge are skillfully brought to a higher level of maturity, integrated with existing abilities, and used functionally. Learning with, and through, peers, provides the opportunity to address a core deficit of autism at an early age: abnormal peer relationships for developmental level (APA, 2000). Providing an enriched environment with toys, structured learning, and opportunities for ongoing engagement week may offer the children experiences that they would not otherwise have (Ramey & Ramey, 1998). Parent training sessions will focus on strategies aimed at improving child social engagement and communication. Parent education sessions will focus on topics related to autism characteristics, learning styles, interventions, and resources.
Experimental: Parent Mediated Parent training sessions are given 2 times a month at our center and once a month at home for 60-90 minutes each. Parents are taught strategies on how to interact with their children to increase their skills. Treatment will last for 6 months.	Behavioral: Social communication Parent training sessions will focus on teaching parents strategies for enhancing their child's social engagement and communication. Since parents will be using these strategies across all activities throughout the day, there is an increased likelihood of generalization. For parents of minority and underserved children, this may be the first exposure to responsive interaction strategies (Rudy & Grusec, 2001).

Arms

Assigned Interventions

Experimental: Center-Based classroom intervention

Center-Based classroom intervention

Four days a week for 2.5 hours a day the child will participate in a classroom with peers in an attempt to increase social communication, language abilities, and other skills. Parents will also receive education sessions 1-3 times per month for 1-2 hours each. Treatment will last for 6 months.

Behavioral: Social Communication

Intervention in the Center-Based classroom intervention will be conducted at the Center for Autism and Related Disorders and focuses on providing children with an invigorating, motivating learning environment in which emerging skills and knowledge are skillfully brought to a higher level of maturity, integrated with existing abilities, and used functionally. Learning with, and through, peers, provides the opportunity to address a core deficit of autism at an early age: abnormal peer relationships for developmental level (APA, 2000). Providing an enriched environment with toys, structured learning, and opportunities for ongoing engagement week may offer the children experiences that they would not otherwise have (Ramey & Ramey, 1998). Parent training sessions will focus on strategies aimed at improving child social engagement and communication. Parent education sessions will focus on topics related to autism characteristics, learning styles, interventions, and resources.

Experimental: Parent Mediated

Parent training sessions are given 2 times a month at our center and once a month at home for 60-90 minutes each. Parents are taught strategies on how to interact with their children to increase their skills. Treatment will last for 6 months.

Behavioral: Social communication

Parent training sessions will focus on teaching parents strategies for enhancing their child's social engagement and communication. Since parents will be using these strategies across all activities throughout the day, there is an increased likelihood of generalization. For parents of minority and underserved children, this may be the first exposure to responsive interaction strategies (Rudy & Grusec, 2001).

Eligibility

Ages Eligible for Study:	22 Months to 33 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Participants must be 22 to 33 months old
Children must meet criteria for ASD or autism on the ADOS plus receive a clinical judgment of PDD-NOS or autism by the study team
Children must have an age equivalent of 8 months or greater for non-verbal ability based on the Mullen Visual Reception and Fine Motor scales
Parents must agree to participate in the study and commit to having their child participate in the intervention to which they are randomized for 6 months
The parent (or other primary caregiver, such as grandparent) in the Parent-Mediated condition must agree to attend the training sessions three times per month
Parents must be between the ages of 16 and 50 years old
Families who qualify for medical assistance and/or have racial/ethnic minority backgrounds will be prioritized for recruitment and participation in this study. On the TSI, we will ask participants if they qualify for medical assistance or if they are of a racial minority or have a first degree relative of a racial minority. Families who do not fit these criteria will be notified that they may be eligible to participate if additional space is available.
It is not required that English be their primary language, but they must be fluent in English (or if the child is nonverbal he/she must hear English most of the time at home)

Exclusion Criteria:

Head injury prior to enrollment in the study
Major hearing or visual impairment after correction
Non-febrile seizures
PKU (Phenylketonuria)
Congenital Rubella (German measles)
Neurofibromatosis
Tuberous Sclerosis
Fragile X
A fall resulting in a loss of consciousness or other severe head injury
Velo-Cardio Facial Syndrome
Any other known genetic syndrome
No foster children may participate
The child must not be adopted

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01008800

Contacts

Contact: Rebecca Landa, PhD, CCC-SLP	443-923-7680
Contact: Catherine Walton, MS	443-923-7608	waltonc@kennedykrieger.org

Locations

United States, Maryland
Kennedy Krieger Institute	Recruiting
Baltimore, Maryland, United States, 21211
Contact: Rebecca Landa, PhD, CCC-SLP 443-923-7551 landa@kennedykrieger.org
Contact: Catherine Walton, MS 443-923-7630 waltonc@kennedykrieger.org
Principal Investigator: Rebecca Landa, PhD, CCC-SLP

Sponsors and Collaborators

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

HRSA/Maternal and Child Health Bureau

Investigators

Principal Investigator:

Rebecca Landa, PhD, CCC-SLP

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

More Information

Publications:

Sofronoff K, Farbotko M. The effectiveness of parent management training to increase self-efficacy in parents of children with Asperger syndrome. Autism. 2002 Sep;6(3):271-86.

Tannock R, Girolametto L, Siegel LS. Language intervention with children who have developmental delays: effects of an interactive approach. Am J Ment Retard. 1992 Sep;97(2):145-60.

McGee, G. G., Morrier, M. J., & Daly,T. (1999).An incidental teaching approach to early intervention for toddlers with autism. Journal of the Association for Persons with Severe Handicaps, 24, 133-146.

Rutter M. Diagnosis and definition of childhood autism. J Autism Child Schizophr. 1978 Jun;8(2):139-61. No abstract available.

Kasari C, Freeman S, Paparella T. Joint attention and symbolic play in young children with autism: a randomized controlled intervention study. J Child Psychol Psychiatry. 2006 Jun;47(6):611-20. Erratum in: J Child Psychol Psychiatry. 2007 May;48(5):523.

Responsible Party:	Rebecca Landa, Principal Investigator, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
ClinicalTrials.gov Identifier:	NCT01008800 History of Changes
Other Study ID Numbers:	R40 MC 15594-01, NA_00030329
Study First Received:	November 5, 2009
Last Updated:	August 29, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.:

Autism Spectrum Disorder
language
social
toddlers

Additional relevant MeSH terms:

Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on February 09, 2012