Clinical trial NCT01008800: A Randomized Clinical Trial for Toddlers With ASD
Official title: Parent-mediated vs Center-based Intervention for Toddlers With ASD: An RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Autism Spectrum Disorder
language
social
toddlers
Lead sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Sponsor class: OTHER
Collaborators: name: HRSA/Maternal and Child Health Bureau
First posted: 2009-11-06
Enrollment: 196
Sex: ALL
Minimum age (years): 22
Maximum age (years): 33
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Communication and Symbolic Behavior Scales
timeFrame: immediately after treatment ends and 6 months after treatment ends
Secondary outcomes:
measure: Mullen Scales of Early Learning
timeFrame: immediately after treatment ends and 6 months after treatment ends
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Kennedy Krieger Institute
state: Maryland
Study officials:
affiliation: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
name: Rebecca Landa, PhD, CCC-SLP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1177/1362361302006003005.
citation: 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.
citation: 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.
citation: Rutter M. Diagnosis and definition of childhood autism. J Autism Child Schizophr. 1978 Jun;8(2):139-61. doi: 10.1007/BF01537863. No abstract available.
citation: 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. doi: 10.1111/j.1469-7610.2005.01567.x.