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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Nationwide Children's Hospital
Sponsor:
Information provided by (Responsible Party):
Kelly Tanner, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01977248
First received: October 14, 2013
Last updated: May 30, 2014
Last verified: May 2014
  Purpose

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 Intervention
Autism Spectrum Disorder
Autistic Disorder
Behavioral: Sensorimotor Affect Relationship-based Therapy (SMART)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sensorimotor Affect Relationship-based Therapy (SMART) for Children With Autism Spectrum Disorders Ages 2-12

Resource links provided by NLM:


Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    Parent-report questionnaire.


Estimated Enrollment: 40
Study Start Date: October 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   2 Years to 12 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01977248

Contacts
Contact: Gina Vasiloff, MA 614-355-8225 gina.vasiloff@nationwidechildrens.org
Contact: Jenna Aubuchon, MS 614-722-3989 jenna.aubuchon@nationwidechildrens.org

Locations
United States, Ohio
Nationwide Children's Hospital Hilliard Close to Home Recruiting
Hilliard, Ohio, United States, 43026
Contact: Gina Vasiloff, MA    614-355-8225    gina.vasiloff@nationwidechildrens.org   
Contact: Cynthia Preston, BA    614-760-1600    cynthia.preston@nationwidechildrens.org   
Principal Investigator: Kelly J Tanner, MOT         
Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
Principal Investigator: Kelly J Tanner, MOT Nationwide Children's Hospital
  More Information

No publications provided

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
Study First Received: October 14, 2013
Last Updated: May 30, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Disease
Mental Disorders
Mental Disorders Diagnosed in Childhood
Pathologic Processes

ClinicalTrials.gov processed this record on November 27, 2014