NCT00518804

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. 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. 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. 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. 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 21, 2007

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

December 5, 2008

Status Verified

July 1, 2008

First QC Date

August 17, 2007

Last Update Submit

December 4, 2008

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Interventions

Eligibility Criteria

Age3 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University

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

RECRUITING

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Jo-Ann Reitzel, PhD.

    McMaster University, Department of Psychiatry and Behavioural Neurosciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jo-Ann Reitzel, PhD.

CONTACT

Tamara Lazoff, BScH.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 17, 2007

First Posted

August 21, 2007

Study Start

August 1, 2007

Study Completion

August 1, 2009

Last Updated

December 5, 2008

Record last verified: 2008-07

Locations