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

NCT01977248 | Completed

• 1 other identifier: IRB13-00460
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder; Autistic Disorder

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

SMART therapy

EXPERIMENTAL

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

Sensorimotor Affect Relationship-based Therapy (SMART) BEHAVIORAL

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.

SMART therapy

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (1)

Nationwide Children's Hospital Hilliard Close to Home

Hilliard, Ohio, 43026, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Kelly J Tanner, MOT

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Occupational Therapy Research Coordinator

Study Record Dates

• First Submitted: October 14, 2013
• First Posted: November 6, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 4, 2015

Record last verified: 2015-02

Locations

US (1)