- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02153203
Using the Prevent-Teach-Reinforce Model to Reduce Problem Behaviors in Children With Autism Spectrum Disorders
October 24, 2016 updated by: Marc Lanovaz, Université de Montréal
Children with autism spectrum disorders often engage in problem behaviors such as self-injury, destruction, aggression, and stereotypy.
Prior research has clearly shown that these problem behaviors may interfere with learning, daily functioning, and social participation.
As such, engaging in problem behaviors has a negative impact on the health and quality of life of children with autism spectrum disorders and their families.
One promising solution to reduce problem behaviors in this population is the Prevent-Teach-Reinforce (PTR) model, which relies on the evidence-based practices of positive behavior support.
Although the use of PTR has been gaining considerably support in schools, the model has never been evaluated as part of a rigorous large-scale study using parents as interventionists.
Thus, the purpose of the project is to conduct an assessment of the effectiveness of a home-based version of the PTR model in reducing problem behaviors in children with autism spectrum disorders and in improving families' quality of life.
Our hypotheses are that implementing the PTR will (a) produce larger reductions in problem behaviors than participating in an individual parent training session, (b) increase engagement in prosocial behaviors, (c) decrease parental stress, and (c) improve the quality of life of the family.
The results of the study will allow an examination of whether PTR is an effective and acceptable model to reduce problem behaviors at home in this population.
Given that problem behaviors incur high societal costs when they persist into adolescence and adulthood, the study may potentially lead to large cost reductions in the treatment of difficulties associated with autism spectrum disorders.
By reducing engagement in problem behaviors, the implementation of the model may also promote and facilitate the social participation as well as improve the quality of life and health of children with autism spectrum disorders and their families.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
42
Phase
- 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 Locations
-
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Quebec
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Lachine, Quebec, Canada
- West Montreal Readaptation Centre
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Montreal, Quebec, Canada
- Gold Centre
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Montréal, Quebec, Canada, H3L 3T1
- CRDITED de Montréal
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-
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
Ages Eligible for Study
No older than 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Clinical diagnosis of autism spectrum disorder
- Must exhibit problem behavior
Exclusion Criteria:
- Already receiving services to reduce problem behaviors at home
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Behavioral approach
The Prevent-Teach-Reinforce Model will be implemented with families in their home settings.
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Implementation of the model once to twice per week over a period of 8 weeks
|
Active Comparator: Educational approach
Each child's parent will participate in one 2- to 3-hour individual parent training session on the assessment and treatment of problem behavior in children with autism spectrum disorders.
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One 2- to 3-hour individual parent training session on the assessment and treatment of problem behavior
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in parental report of problem behavior at 8 weeks
Time Frame: Prior to the start of the intervention and 8 weeks later
|
Problem behavior scale of the Problem Behavior Inventory
|
Prior to the start of the intervention and 8 weeks later
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in quality of life at 8 weeks
Time Frame: Prior to the start of the intervention and 8 weeks later
|
Beach Center Family Quality of Life Scale
|
Prior to the start of the intervention and 8 weeks later
|
Change from baseline in parental report of stress at 20 weeks
Time Frame: Prior to the start of the intervention and 20 weeks later
|
Parenting Stress Index Short Form
|
Prior to the start of the intervention and 20 weeks later
|
Change from baseline in parental report of stress at 8 weeks
Time Frame: Prior to the start of the intervention and 8 weeks later
|
Parenting Stress Index Short Form
|
Prior to the start of the intervention and 8 weeks later
|
Change from baseline in quality of life at 20 weeks
Time Frame: Prior to the start of the intervention and 20 weeks later
|
Beach Center Family Quality of Life Scale
|
Prior to the start of the intervention and 20 weeks later
|
Social validity of the intervention
Time Frame: After 8 weeks of intervention
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Treatment Acceptability Rating Form - Revised
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After 8 weeks of intervention
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Change from baseline in parental report of problem behavior at 20 weeks
Time Frame: Prior to the start of the intervention and 20 weeks later
|
Problem behavior scale of the Problem Behavior Inventory
|
Prior to the start of the intervention and 20 weeks later
|
Change from baseline in parental report of positive social behavior at 20 weeks
Time Frame: Prior to the start of the intervention and 20 weeks later
|
Positive social behavior scale of the Nisonger Child Behavior Rating Form
|
Prior to the start of the intervention and 20 weeks later
|
Change from baseline in parental report of positive social behavior at 8 weeks
Time Frame: Prior to the start of the intervention and 8 weeks later
|
Positive social behavior scale of the Nisonger Child Behavior Rating Form
|
Prior to the start of the intervention and 8 weeks later
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marc Lanovaz, Université de Montréal
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
October 1, 2014
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
May 29, 2014
First Submitted That Met QC Criteria
May 29, 2014
First Posted (Estimate)
June 2, 2014
Study Record Updates
Last Update Posted (Estimate)
October 25, 2016
Last Update Submitted That Met QC Criteria
October 24, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CERFAS-2014-15-058-P
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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