Functional Behavioural Skill Training for Young Children With Severe Autism

LAY SUMMARY:

IBI is costly and there are currently long waitlists of children who are in need of treatment. The investigators have clinical and ethical obligations to determine more appropriate alternatives to IBI for children making few gains because all children with autism deserve treatment based on their needs. This study is designed to determine the effectiveness of a functional skills group intervention, based on the principles of applied behaviour analysis, for children responding slowly to IBI. Specifically, it will investigate the effectiveness of functional behavioural skills training in addition to IBI at increasing a child's independence in day to day communication and self-help skills and reducing behaviour problems, as well as increasing parental competence and decreasing caregiver strain compared with IBI alone. Having an effective alternative to IBI for children making few gains is relevant from the standpoint of i) preventing exposure to potentially intrusive interventions for those children making few gains in IBI, ii) allowing children making few gains in IBI to access effective treatment, iii) opening limited IBI spots for children who would benefit from IBI, and iv) making better use of limited health resources. Overall, the results will be of interest to parent, clinicians, researchers and funding bodies.

HYPOTHESES

Four main hypotheses are presented to examine the effectiveness of involvement in the ABA functional skills group in improving parent training and functional skills and behaviour in young children with ASD who do not master the ELM. We focus our hypotheses on child measures of functional self help skills, behaviour and cognition as well as parental measures of caregiver strain and sense of competence.

Participants (i.e. children predicted to have poor response to IBI alone) who attend the functional skills group for 8 months will have:

1. greater decreases in interfering behaviour as measured on the Developmental Behaviour Checklist and ratings of behaviour during observations compared to children receiving IBI alone.
2. greater increases in self-help as measured on the Vineland Adaptive Behaviour Scales II, and greater independence in eating, toileting, requesting, hand washing, and responding to name as measured by independent ratings of these skills compared with those children receiving IBI alone.
3. parents of these children will have greater improvements in their sense of competence as a parent and greater reductions in caregiver strain, compared with parents of children receiving IBI alone.
4. a similar pattern of little or no change in cognitive function compared with children who receive only IBI based on the Stanford Binet. In other words, there will be no difference between the experimental and control group on the measure of cognitive functioning

Study Overview

• Status: Unknown
• Conditions: Autistic Disorder
• Intervention / Treatment: Behavioral: Functional Behavioural Skills Group and Parent Training

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • 1280 Main Street West, Hamilton, Ontario, Canada, L8S 4L8
      • Recruiting
      • McMaster University
      • Contact: Jo-Ann Reitzel, PhD.; Phone Number: 77922 905-521-2100; Email: reitzel@hhsc.ca
      • Principal Investigator: Jo-Ann Reitzel, PhD
      • Sub-Investigator: Peter Szatmari, MD, MSc
      • Sub-Investigator: Lonnie Zwaigenbaum, MD, MSc
      • Sub-Investigator: Jane Summers, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children receiving Intensive Behavioural Intervention from the Hamilton Niagara Regional Early Autism Intervention Program who do not master the Early Learning Measure after 4 months of treatment

Exclusion Criteria:

• Children receiving Intensive Behavioural Intervention from the Hamilton Niagara Regional Early Autism Intervention Program who master the Early Learning Measure after 4 months of treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Parenting Sense of Competence	Before entry to and upon exit from the intervention
Child Behavioural Skills Assessment	Before entry to and upon exit from the intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
Child Intellectual Functioning	Before entry to and upon exit from the intervention
Child Language Functioning	Before entry to and upon exit from the intervention
Child Adaptive Behaviour	Before entry to and upon exit from the intervention
Child Maladaptive Behaviour	Before entry to and upon exit from the intervention
Caregiver Strain	Before entry to and upon exit from the intervention
Parent Behaviour Skills Assessment	Before entry to and upon exit from the intervention

Collaborators and Investigators

• Sponsor: Hamilton Health Sciences Corporation
• Investigators: Principal Investigator: Jo-Ann Reitzel, PhD., McMaster University, Department of Psychiatry and Behavioural Neurosciences

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Study Completion (Anticipated): August 1, 2009

Study Registration Dates

• First Submitted: August 17, 2007
• First Submitted That Met QC Criteria: August 17, 2007
• First Posted (Estimate): August 21, 2007

Study Record Updates

• Last Update Posted (Estimate): December 5, 2008
• Last Update Submitted That Met QC Criteria: December 4, 2008
• Last Verified: July 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Autistic Disorder
• Other Study ID Numbers: Reitzel 2007