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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02153203
Other study ID # CERFAS-2014-15-058-P
Secondary ID
Status Completed
Phase N/A
First received May 29, 2014
Last updated October 24, 2016
Start date October 2014
Est. completion date September 2016

Study information

Verified date October 2016
Source Université de Montréal
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date September 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender Both
Age group N/A to 12 Years
Eligibility Inclusion Criteria:

- Clinical diagnosis of autism spectrum disorder

- Must exhibit problem behavior

Exclusion Criteria:

- Already receiving services to reduce problem behaviors at home

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Prevent-Teach-Reinforce Model
Implementation of the model once to twice per week over a period of 8 weeks
Other:
Individual Parent Training Session
One 2- to 3-hour individual parent training session on the assessment and treatment of problem behavior

Locations

Country Name City State
Canada West Montreal Readaptation Centre Lachine Quebec
Canada Gold Centre Montreal Quebec
Canada CRDITED de Montréal Montréal Quebec

Sponsors (1)

Lead Sponsor Collaborator
Université de Montréal

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in parental report of problem behavior at 8 weeks Problem behavior scale of the Problem Behavior Inventory Prior to the start of the intervention and 8 weeks later No
Secondary Change from baseline in quality of life at 8 weeks Beach Center Family Quality of Life Scale Prior to the start of the intervention and 8 weeks later No
Secondary Change from baseline in parental report of stress at 20 weeks Parenting Stress Index Short Form Prior to the start of the intervention and 20 weeks later No
Secondary Change from baseline in parental report of stress at 8 weeks Parenting Stress Index Short Form Prior to the start of the intervention and 8 weeks later No
Secondary Change from baseline in quality of life at 20 weeks Beach Center Family Quality of Life Scale Prior to the start of the intervention and 20 weeks later No
Secondary Social validity of the intervention Treatment Acceptability Rating Form - Revised After 8 weeks of intervention No
Secondary Change from baseline in parental report of problem behavior at 20 weeks Problem behavior scale of the Problem Behavior Inventory Prior to the start of the intervention and 20 weeks later No
Secondary Change from baseline in parental report of positive social behavior at 20 weeks Positive social behavior scale of the Nisonger Child Behavior Rating Form Prior to the start of the intervention and 20 weeks later No
Secondary Change from baseline in parental report of positive social behavior at 8 weeks Positive social behavior scale of the Nisonger Child Behavior Rating Form Prior to the start of the intervention and 8 weeks later No
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