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

February 3, 2015 updated by: Kelly Tanner, Nationwide Children's Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Hilliard, Ohio, United States, 43026
        • Nationwide Children's Hospital Hilliard Close to Home

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Upon enrollment in the study (baseline), day 1 of treatment, and end of treatment for each 12 week session (up to 4 sessions)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nationwide Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

October 14, 2013

First Submitted That Met QC Criteria

October 31, 2013

First Posted (Estimate)

November 6, 2013

Study Record Updates

Last Update Posted (Estimate)

February 4, 2015

Last Update Submitted That Met QC Criteria

February 3, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB13-00460

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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