Functional Behavioural Skill Training for Young Children With Severe Autism
Primary Purpose
Autistic Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Functional Behavioural Skills Group and Parent Training
Sponsored by
About this trial
This is an interventional treatment trial for Autistic Disorder
Eligibility Criteria
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
Sites / Locations
- McMaster UniversityRecruiting
Outcomes
Primary Outcome Measures
Parenting Sense of Competence
Child Behavioural Skills Assessment
Secondary Outcome Measures
Child Intellectual Functioning
Child Language Functioning
Child Adaptive Behaviour
Child Maladaptive Behaviour
Caregiver Strain
Parent Behaviour Skills Assessment
Full Information
NCT ID
NCT00518804
First Posted
August 17, 2007
Last Updated
December 4, 2008
Sponsor
Hamilton Health Sciences Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00518804
Brief Title
Functional Behavioural Skill Training for Young Children With Severe Autism
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Unknown status
Study Start Date
August 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hamilton Health Sciences Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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:
greater decreases in interfering behaviour as measured on the Developmental Behaviour Checklist and ratings of behaviour during observations compared to children receiving IBI alone.
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.
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autistic Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Functional Behavioural Skills Group and Parent Training
Primary Outcome Measure Information:
Title
Parenting Sense of Competence
Time Frame
Before entry to and upon exit from the intervention
Title
Child Behavioural Skills Assessment
Time Frame
Before entry to and upon exit from the intervention
Secondary Outcome Measure Information:
Title
Child Intellectual Functioning
Time Frame
Before entry to and upon exit from the intervention
Title
Child Language Functioning
Time Frame
Before entry to and upon exit from the intervention
Title
Child Adaptive Behaviour
Time Frame
Before entry to and upon exit from the intervention
Title
Child Maladaptive Behaviour
Time Frame
Before entry to and upon exit from the intervention
Title
Caregiver Strain
Time Frame
Before entry to and upon exit from the intervention
Title
Parent Behaviour Skills Assessment
Time Frame
Before entry to and upon exit from the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jo-Ann Reitzel, PhD.
Phone
905-521-2100
Ext
77922
Email
reitzel@hhsc.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Tamara Lazoff, BScH.
Phone
905-521-2100
Ext
77631
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jo-Ann Reitzel, PhD.
Organizational Affiliation
McMaster University, Department of Psychiatry and Behavioural Neurosciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University
City
1280 Main Street West, Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4L8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jo-Ann Reitzel, PhD.
Phone
905-521-2100
Ext
77922
Email
reitzel@hhsc.ca
First Name & Middle Initial & Last Name & Degree
Jo-Ann Reitzel, PhD
First Name & Middle Initial & Last Name & Degree
Peter Szatmari, MD, MSc
First Name & Middle Initial & Last Name & Degree
Lonnie Zwaigenbaum, MD, MSc
First Name & Middle Initial & Last Name & Degree
Jane Summers, PhD
12. IPD Sharing Statement
Learn more about this trial
Functional Behavioural Skill Training for Young Children With Severe Autism
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