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Completed

NCT Number: NCT01179841

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

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.

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Key information

Conditions

Autism Spectrum Disorder Behavior Child Development Disorders, Pervasive Communication Language Mental Disorders Neurodevelopmental Disorders

Age range

11 month–21 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kennedy Krieger Institute

Baltimore, Maryland, 21211, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Playgroup

Behavioral

The playgroup will be conducted at our center and focuses on providing an invigorating learning environment in which emerging skills/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 abnormal peer relationships for developmental level. Providing an enriched environment with toys, structured learning, and opportunities for ongoing engagement we offer the children experiences that they would not otherwise have. 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, learning styles, interventions, and resources.

Parent Training

Behavioral

The 1-2 hour individual therapeutic sessions with parent training in the home or clinic (1x every week over six months) are based on our own program which is in development. This program focuses on teaching parents how to encourage social and communication skills in their toddlers and also provides comprehensive information about development. Sessions will focus on knowledge of autism, current access to services, general knowledge of strategies used to facilitate child development, advocacy, knowledge of how to access services, and coping strategies.

Other names: Enrichment Sessions

Primary outcomes

  1. Developmental Level

    Time frame: 3 months into treatment, 6 months into treatment, and 6 months after treatment ends

    Using the Mullen Scales of Early Learning to assess.

Secondary outcomes

  1. Communication

    Time frame: 3 months after treatment starts

    Using Communication and Symbolic Behavior Scales to assess.

  2. Communication

    Time frame: 6 months into treatment

    Using Communication and Symbolic Behavior Scales to assess.

  3. Communication

    Time frame: 6 months after treatment ends

    Using Communication and Symbolic Behavior Scales to assess.

  4. Presence and Severity of Autism

    Time frame: 3 months after treatment starts

    Using Autism Diagnostic Observation Schedule to assess.

  5. Presence and Severity of Autism

    Time frame: 6 months into treatment

    Using Autism Diagnostic Observation Schedule to assess.

  6. Presence and Severity of Autism

    Time frame: 6 months after treatment ends

    Using Autism Diagnostic Observation Schedule to assess.

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Autism Speaks

Registry information

Official study title

A Comprehensive Approach to Intervention for Toddlers at Risk for ASD

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Aug 11, 2010
Registry last updated
Mar 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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