Functional Behavioural Skill Training for Young Children With Severe Autism

Autistic Disorder Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00518804
• Other study ID #: Reitzel 2007
• Status: Recruiting
• Phase: N/A
• First received: August 17, 2007
• Last updated: December 4, 2008
• Start date: August 2007
• Est. completion date: August 2009

Study information

• Verified date: July 2008
• Source: McMaster University
• Contact: Jo-Ann Reitzel, PhD.
• Phone: 905-521-2100
• Email: reitzel[@]hhsc.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical 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. 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 10 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autistic Disorder

Intervention

Behavioral:
• Functional Behavioural Skills Group and Parent Training

Locations

Country	Name	City	State
Canada	McMaster University	1280 Main Street West, Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parenting Sense of Competence		Before entry to and upon exit from the intervention
Primary	Child Behavioural Skills Assessment		Before entry to and upon exit from the intervention
Secondary	Child Intellectual Functioning		Before entry to and upon exit from the intervention
Secondary	Child Language Functioning		Before entry to and upon exit from the intervention
Secondary	Child Adaptive Behaviour		Before entry to and upon exit from the intervention
Secondary	Child Maladaptive Behaviour		Before entry to and upon exit from the intervention
Secondary	Caregiver Strain		Before entry to and upon exit from the intervention
Secondary	Parent Behaviour Skills Assessment		Before entry to and upon exit from the intervention

External Links

•   Description of project on funding organizations' website