Intervention for Toddlers at Risk for Autism Spectrum Disorders (ASD)

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

Status

Completed

Conditions

Autism Spectrum Disorder

Treatments

Behavioral: Parent Training

Behavioral: Playgroup

Study type

Interventional

Funder types

Other

Identifiers

NCT01179841

NA_00006553

Details and patient eligibility

About

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.

Enrollment

49 patients

Sex

All

Ages

11 to 21 months old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

49 participants in 2 patient groups

Playgroup and Parent Training

Experimental group

Description:

1. One to two-hour individual therapeutic sessions with parent training in the home or clinic, 1x every week over six months; 2. parent training/enrichment once a week in our clinic for 20 sessions at 1-2 hours; 3. a playgroup session for 1-2 hours 2x week for 6 months in our clinic and 4. Community treatment as usual.

Treatment:

Behavioral: Parent Training

Behavioral: Playgroup

Parent Training

Active Comparator group

Description:

1. Parent enrichment sessions once a week for 20 sessions (for 1-2 hours) 2. Community treatment as usual.

Treatment:

Behavioral: Parent Training