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

Autism Spectrum Disorder Clinical Trial

— SMART  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01977248
• Other study ID #: IRB13-00460
• Status: Completed
• Phase: N/A
• First received: October 14, 2013
• Last updated: February 3, 2015
• Start date: October 2013
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 12 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive
• Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital Hilliard Close to Home	Hilliard	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pervasive Developmental Disorder Behavior Inventory (PDDBI)	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)	No