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Sensorimotor Affect Relationship-based Therapy (SMART) for Children With Autism Spectrum Disorders Ages 2-12 (SMART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01977248
Recruitment Status : Completed
First Posted : November 6, 2013
Last Update Posted : February 4, 2015
Sponsor:
Information provided by (Responsible Party):
Kelly Tanner, Nationwide Children's Hospital

Brief Summary:
The SMART Program at Nationwide Children's Hospital is an interdisciplinary social skills group that teaches children with autism spectrum disorders (ASD) ages 2-12 the fundamental social skills necessary to build and maintain relationships. The manualized curriculum addresses skills such as joint attention, eye contact, play, and peer engagement. Currently individual goals are set for each child who participates and this is documented in the daily treatment note. In order to research group outcomes, the investigators will use parent questionnaires (an addition to current clinical practices) to measure changes in behavior after each 12 week session for up to one year of treatment. The investigators hypothesize that maladaptive behaviors will decrease and adaptive behaviors will increase in children with ASD after participation in the SMART program.

Condition or disease Intervention/treatment
Autism Spectrum Disorder Autistic Disorder Behavioral: Sensorimotor Affect Relationship-based Therapy (SMART)

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sensorimotor Affect Relationship-based Therapy (SMART) for Children With Autism Spectrum Disorders Ages 2-12
Study Start Date : October 2013
Primary Completion Date : December 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: SMART therapy
The Sensorimotor Affect Relationship-based Therapy (SMART) program is an interdisciplinary program that teaches children ages 2-12.5 the fundamental skills necessary to build and maintain relationships. Sessions last for 12 weeks at a time and address skills such as: tolerance for sitting and structure, joint attention, eye contact, transitions between activities, participation in group activities, communication skills, and play skills.
Behavioral: Sensorimotor Affect Relationship-based Therapy (SMART)
The SMART Program is an interdisciplinary program that teaches children ages 2-12.5 the fundamental skills necessary to build and maintain relationships. Sessions last for 12 weeks at a time and address skills such as: tolerance for sitting and structure, joint attention, eye contact, transitions between activities, participation in group activities, communication skills, and play skills.



Primary Outcome Measures :
  1. Pervasive Developmental Disorder Behavior Inventory (PDDBI) [ Time Frame: Upon enrollment in the study (baseline), day 1 of treatment, and end of treatment for each 12 week session (up to 4 sessions) ]
    Parent-report questionnaire.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages 2 to 12.5
  • Diagnosis of ASD OR who meet a minimum ASD cutoff score on a screening questionnaire (SCQ or ASQ:SE, depending on age)

Exclusion Criteria:

  • Non-English speaking
  • Uncorrected vision disorder
  • Moderate to severe hearing loss
  • Non-ambulatory
  • Previous participation in a SMART group
  • Accompaniment by aide
  • Extreme behavioral disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01977248


Locations
United States, Ohio
Nationwide Children's Hospital Hilliard Close to Home
Hilliard, Ohio, United States, 43026
Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
Principal Investigator: Kelly J Tanner, MOT Nationwide Children's Hospital

Responsible Party: Kelly Tanner, Occupational Therapy Research Coordinator, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01977248     History of Changes
Other Study ID Numbers: IRB13-00460
First Posted: November 6, 2013    Key Record Dates
Last Update Posted: February 4, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders