Functional Behavioural Skill Training for Young Children With Severe Autism

December 4, 2008 updated by: Hamilton Health Sciences Corporation

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Jo-Ann Reitzel, PhD.
  • Phone Number: 77922 905-521-2100
  • Email: reitzel@hhsc.ca

Study Contact Backup

  • Name: Tamara Lazoff, BScH.
  • Phone Number: 77631 905-521-2100

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Parenting Sense of Competence
Time Frame: Before entry to and upon exit from the intervention
Before entry to and upon exit from the intervention
Child Behavioural Skills Assessment
Time Frame: Before entry to and upon exit from the intervention
Before entry to and upon exit from the intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Child Intellectual Functioning
Time Frame: Before entry to and upon exit from the intervention
Before entry to and upon exit from the intervention
Child Language Functioning
Time Frame: Before entry to and upon exit from the intervention
Before entry to and upon exit from the intervention
Child Adaptive Behaviour
Time Frame: Before entry to and upon exit from the intervention
Before entry to and upon exit from the intervention
Child Maladaptive Behaviour
Time Frame: Before entry to and upon exit from the intervention
Before entry to and upon exit from the intervention
Caregiver Strain
Time Frame: Before entry to and upon exit from the intervention
Before entry to and upon exit from the intervention
Parent Behaviour Skills Assessment
Time Frame: Before entry to and upon exit from the intervention
Before entry to and upon exit from the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hamilton Health Sciences Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jo-Ann Reitzel, PhD., McMaster University, Department of Psychiatry and Behavioural Neurosciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2007

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 21, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 5, 2008

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2008

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Reitzel 2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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