NCT02153203

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 2, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

October 25, 2016

Status Verified

October 1, 2016

Enrollment Period

1.7 years

First QC Date

May 29, 2014

Last Update Submit

October 24, 2016

Conditions

Keywords

Autism spectrum disorderProblem behavior

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (8)

  • Change from baseline in quality of life at 8 weeks

    Prior to the start of the intervention and 8 weeks later

  • Change from baseline in parental report of stress at 20 weeks

    Prior to the start of the intervention and 20 weeks later

  • Change from baseline in parental report of stress at 8 weeks

    Prior to the start of the intervention and 8 weeks later

  • Change from baseline in quality of life at 20 weeks

    Prior to the start of the intervention and 20 weeks later

  • Social validity of the intervention

    After 8 weeks of intervention

  • +3 more secondary outcomes

Study Arms (2)

Behavioral approach

EXPERIMENTAL

The Prevent-Teach-Reinforce Model will be implemented with families in their home settings.

Behavioral: Prevent-Teach-Reinforce Model

Educational approach

ACTIVE COMPARATOR

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.

Other: Individual Parent Training Session

Interventions

Implementation of the model once to twice per week over a period of 8 weeks

Behavioral approach

One 2- to 3-hour individual parent training session on the assessment and treatment of problem behavior

Educational approach

Eligibility Criteria

AgeUp to 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Clinical diagnosis of autism spectrum disorder
  • Must exhibit problem behavior

You may not qualify if:

  • Already receiving services to reduce problem behaviors at home

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

West Montreal Readaptation Centre

Lachine, Quebec, Canada

Location

CRDITED de Montréal

Montreal, Quebec, H3L 3T1, Canada

Location

Gold Centre

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Child Development Disorders, PervasiveAutism Spectrum DisorderProblem Behavior

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental DisordersBehavioral SymptomsBehaviorChild Behavior

Study Officials

  • Marc Lanovaz

    Université de Montréal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 29, 2014

First Posted

June 2, 2014

Study Start

October 1, 2014

Primary Completion

June 1, 2016

Study Completion

September 1, 2016

Last Updated

October 25, 2016

Record last verified: 2016-10

Locations