Clinical trial NCT01179841: Intervention for Toddlers at Risk for Autism Spectrum Disorders (ASD)
Official title: A Comprehensive Approach to Intervention for Toddlers at Risk for ASD
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: Autism Speaks
First posted: 2010-08-11
Enrollment: 49
Sex: ALL
Minimum age (years): 11
Maximum age (years): 21
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 an early intervention model for very young children at high risk for autism spectrum disorders (ASD) and their families. If children show improvement in this intervention, the investigators hope that the availability of public services of this type will be increased. Children between 11 months and 21 months old with Autism Spectrum Disorders, or with social and communication delays that indicate high risk for Autism Spectrum Disorders, and their parents may join the study. Treatment must start prior to the second birthday.


Eligibility criteria: Inclusion Criteria:

* Children will be ascertained between 11 months and 21 months of age
* Must be able to enter the study prior to their second birthday
* Must then pass an eligibility assessment to determine whether the child meets criteria for ASD and thus qualifies for the study. This assessment will consist of the Baby ADOS and the Mullen Scales of Early Learning. Children must meet criteria for ASD or autism on the ADOS, score more than one standard deviation below the mean on the Receptive or Expressive Language scale of the MSEL, and have a clinical judgment of ASD to be eligible for enrollment into treatment.
* 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 Enrichment/Training condition must agree to attend the training sessions

Exclusion Criteria:

* Fail hearing or vision screening (by pediatrician's office, audiologist, or ophthalmologist)
* Family's first language being other than English (language measures are normed on English speakers, putting non-English speakers at a disadvantage. In addition, the treatment is delivered in English. Children from non-English speaking homes may not make progress, but for reasons other than the efficacy of the intervention.)
* Head injury (because this may cause some of the symptoms, which may not be due to autism and therefore we would not be able to assess the effects of the intervention on autism)
* Identified reason for the autism (e.g., fragile X syndrome, Rett syndrome, Tuberous Sclerosis)
* Inability of the family to attend the playgroup sessions and parent trainings
* Parents whose hearing or vision is not within normal limits after correction (e.g., hearing aid, glasses)
* Parents with developmental delays, language or learning impairments, or a psychiatric diagnosis IF the impairment would interfere with parent training (PI will assess on a case by case basis by talking to the parent)
* Foster children
* Refusal to allow videotaping of the children's assessments or intervention or to allow videotaped footage to be used for teaching purposes.

Primary outcomes:
measure: Developmental Level
timeFrame: 3 months into treatment, 6 months into treatment, and 6 months after treatment ends
Secondary outcomes:
measure: Communication
timeFrame: 3 months after treatment starts
measure: Communication
timeFrame: 6 months into treatment
measure: Communication
timeFrame: 6 months after treatment ends
measure: Presence and Severity of Autism
timeFrame: 3 months after treatment starts
measure: Presence and Severity of Autism
timeFrame: 6 months into treatment
measure: Presence and Severity of Autism
timeFrame: 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: Keen D, Rodger S, Doussin K, Braithwaite M. A pilot study of the effects of a social-pragmatic intervention on the communication and symbolic play of children with autism. Autism. 2007 Jan;11(1):63-71. doi: 10.1177/1362361307070901.
citation: Solomon R, Necheles J, Ferch C, Bruckman D. Pilot study of a parent training program for young children with autism: the PLAY Project Home Consultation program. Autism. 2007 May;11(3):205-24. doi: 10.1177/1362361307076842.
citation: Howlin P, Gordon RK, Pasco G, Wade A, Charman T. The effectiveness of Picture Exchange Communication System (PECS) training for teachers of children with autism: a pragmatic, group randomised controlled trial. J Child Psychol Psychiatry. 2007 May;48(5):473-81. doi: 10.1111/j.1469-7610.2006.01707.x.