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Autistic DisorderNCT00518804

Functional Behavioural Skill Training for Young Children With Severe Autism

A study testing Functional Behavioural Skills Group and Parent Training in people with Autistic Disorder, run by Hamilton Health Sciences Corporation at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 3 to 10 years
Conditions the study is for
Autistic Disorder
What is being tested?
Functional Behavioural Skills Group and Parent Training
How many people
32 participants
Where
1 siteCanada
Study dates
Aug 2007to Aug 2009
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 10 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Jo-Ann Reitzel, PhD. contact

905-521-2100 ext. 77922

reitzel@hhsc.ca

Tamara Lazoff, BScH. contact

905-521-2100 ext. 77631

Canada1 site, 1 recruiting
  • McMaster University

    1280 Main Street West, Hamilton, Ontario, L8S 4L8

    Jo-Ann Reitzel, PhD., 905-521-2100 ext. 77922, reitzel@hhsc.ca

    Jo-Ann Reitzel, PhD

    Recruiting

Other trials in Canada

About this study

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.

Read more

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
Being tested
Functional Behavioural Skills Group and Parent Training
Medical subject headings
Autistic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Functional Behavioural Skills Group and Parent TrainingBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Parenting Sense of Competence

    Measured: Before entry to and upon exit from the intervention

  2. Child Behavioural Skills Assessment

    Measured: Before entry to and upon exit from the intervention

Secondary outcomes (6)
  1. Child Intellectual Functioning

    Measured: Before entry to and upon exit from the intervention

  2. Child Language Functioning

    Measured: Before entry to and upon exit from the intervention

  3. Child Adaptive Behaviour

    Measured: Before entry to and upon exit from the intervention

  4. Child Maladaptive Behaviour

    Measured: Before entry to and upon exit from the intervention

  5. Caregiver Strain

    Measured: Before entry to and upon exit from the intervention

  6. Parent Behaviour Skills Assessment

    Measured: Before entry to and upon exit from the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2007 (estimated)
  2. Study startAug 2007
  3. Study completionAug 2009 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00518804
Sponsor's protocol ID
Reitzel 2007
Status last verified
Jul 2008
First submitted
17 Aug 2007
Last updated
5 Dec 2008
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Functional Behavioural Skills Group and Parent Training in people with Autistic Disorder, run by Hamilton Health Sciences Corporation at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jo-Ann Reitzel, PhD. (905-521-2100 ext. 77922, reitzel@hhsc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Parenting Sense of Competence (time frame: Before entry to and upon exit from the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2008.

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