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CompletedNCT01977248SMARTUpdated Feb 4, 2015

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

An interventional study of Sensorimotor Affect Relationship-based Therapy (SMART) in Autism Spectrum Disorder and Autistic Disorder, sponsored by Nationwide Children's Hospital. Completed at 1 site in United States. Open to participants aged 2 Years to 12 Years. Per ClinicalTrials.gov, last updated 2015-02-04.

Sponsored by Nationwide Children's Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
37
Allocation
Not applicable
Ages
2 Years to 12 Years
Sex
All
01

Study 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.

02

Conditions studied

03

In context

Autistic Disorder

1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.

This study's enrollment of 37 is below the median of 45 across 1,044 interventional studies indexed under Autistic Disorder.

Browse Autistic Disorder studies →

Lead sponsor

Nationwide Children's Hospital is the lead sponsor of 231 studies on the registry; 43 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 8 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
37 participants (actual)

Study arms

  • 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)

Interventions

  • BehavioralSensorimotor 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.

06

What researchers measure

Primary outcomes

  1. Pervasive Developmental Disorder Behavior Inventory (PDDBI)

    Parent-report questionnaire.

    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)

07

Study locations

1 site
  • Nationwide Children's Hospital Hilliard Close to Home
    Hilliard, Ohio 43026, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01977248
Lead sponsor
Nationwide Children's Hospital
Responsible party
Kelly Tanner (Occupational Therapy Research Coordinator, Nationwide Children's Hospital) — Principal investigator
First posted
Nov 6, 2013
Start date
Oct 2013
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Feb 4, 2015

Study contacts

Kelly J Tanner, MOT
principal investigator · Nationwide Children's Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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