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Functional Behavioural Skill Training for Young Children With Severe Autism

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ClinicalTrials.gov Identifier: NCT00518804
Recruitment Status : Unknown
Verified July 2008 by McMaster University.
Recruitment status was:  Recruiting
First Posted : August 21, 2007
Last Update Posted : December 5, 2008
Sponsor:
Information provided by:
McMaster University

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:

  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

Condition or disease Intervention/treatment Phase
Autistic Disorder Behavioral: Functional Behavioural Skills Group and Parent Training Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : August 2007
Estimated Study Completion Date : August 2009



Primary Outcome Measures :
  1. Parenting Sense of Competence [ Time Frame: Before entry to and upon exit from the intervention ]
  2. Child Behavioural Skills Assessment [ Time Frame: Before entry to and upon exit from the intervention ]

Secondary Outcome Measures :
  1. Child Intellectual Functioning [ Time Frame: Before entry to and upon exit from the intervention ]
  2. Child Language Functioning [ Time Frame: Before entry to and upon exit from the intervention ]
  3. Child Adaptive Behaviour [ Time Frame: Before entry to and upon exit from the intervention ]
  4. Child Maladaptive Behaviour [ Time Frame: Before entry to and upon exit from the intervention ]
  5. Caregiver Strain [ Time Frame: Before entry to and upon exit from the intervention ]
  6. Parent Behaviour Skills Assessment [ Time Frame: Before entry to and upon exit from the intervention ]


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Ages Eligible for Study:   3 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00518804


Contacts
Contact: Jo-Ann Reitzel, PhD. 905-521-2100 ext 77922 reitzel@hhsc.ca
Contact: Tamara Lazoff, BScH. 905-521-2100 ext 77631

Locations
Canada, Ontario
McMaster University Recruiting
1280 Main Street West, Hamilton, Ontario, Canada, L8S 4L8
Contact: Jo-Ann Reitzel, PhD.    905-521-2100 ext 77922    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         
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Investigators
Principal Investigator: Jo-Ann Reitzel, PhD. McMaster University, Department of Psychiatry and Behavioural Neurosciences

Additional Information:
Responsible Party: Dr. Jo-Ann Reitzel, McMaster University
ClinicalTrials.gov Identifier: NCT00518804     History of Changes
Other Study ID Numbers: Reitzel 2007
First Posted: August 21, 2007    Key Record Dates
Last Update Posted: December 5, 2008
Last Verified: July 2008

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders