Child Development Disorders, PervasiveNCT02153203
Using the Prevent-Teach-Reinforce Model to Reduce Problem Behaviors in Children With Autism Spectrum Disorders
A study testing Prevent-Teach-Reinforce Model and Individual Parent Training Session in people with Child Development Disorders, Pervasive, run by Université de Montréal at 3 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages Up to 12 years
- Conditions the study is for
- Child Development Disorders, Pervasive
- What is being tested?
- Prevent-Teach-Reinforce Model and Individual Parent Training Session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 3 sitesCanada
- Study dates
- Oct 2014to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical diagnosis of autism spectrum disorder
- Must exhibit problem behavior
Who cannot join
- Already receiving services to reduce problem behaviors at home
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
West Montreal Readaptation Centre
Lachine, Quebec
CRDITED de Montréal
Montreal, Quebec, H3L 3T1
Gold Centre
Montreal, Quebec
About this study
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.
- Conditions
- Child Development Disorders, Pervasive
- Being tested
- Prevent-Teach-Reinforce Model, Individual Parent Training Session
- Keywords
- Autism spectrum disorder, Problem behavior
- Medical subject headings
- Child Development Disorders, Pervasive, Autism Spectrum Disorder, Problem Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevent-Teach-Reinforce ModelBehavioural
Implementation of the model once to twice per week over a period of 8 weeks
Individual Parent Training SessionOther
One 2- to 3-hour individual parent training session on the assessment and treatment of problem behavior
| Study group | Role | What they receive |
|---|---|---|
| Behavioral approach | Experimental | The Prevent-Teach-Reinforce Model will be implemented with families in their home settings. Receives: 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. Receives: Other: Individual Parent Training Session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in parental report of problem behavior at 8 weeks
Problem behavior scale of the Problem Behavior Inventory
Measured: Prior to the start of the intervention and 8 weeks later
Secondary outcomes (8)
Change from baseline in quality of life at 8 weeks
Beach Center Family Quality of Life Scale
Measured: Prior to the start of the intervention and 8 weeks later
Change from baseline in parental report of stress at 20 weeks
Parenting Stress Index Short Form
Measured: Prior to the start of the intervention and 20 weeks later
Change from baseline in parental report of stress at 8 weeks
Parenting Stress Index Short Form
Measured: Prior to the start of the intervention and 8 weeks later
Change from baseline in quality of life at 20 weeks
Beach Center Family Quality of Life Scale
Measured: Prior to the start of the intervention and 20 weeks later
Social validity of the intervention
Treatment Acceptability Rating Form - Revised
Measured: After 8 weeks of intervention
Change from baseline in parental report of problem behavior at 20 weeks
Problem behavior scale of the Problem Behavior Inventory
Measured: Prior to the start of the intervention and 20 weeks later
Change from baseline in parental report of positive social behavior at 20 weeks
Positive social behavior scale of the Nisonger Child Behavior Rating Form
Measured: Prior to the start of the intervention and 20 weeks later
Change from baseline in parental report of positive social behavior at 8 weeks
Positive social behavior scale of the Nisonger Child Behavior Rating Form
Measured: Prior to the start of the intervention and 8 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2014 (estimated)
- Study startOct 2014
- Primary completionJun 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child Development Disorders, PervasiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Lanovaz, Université de Montréal
- Investigators
- Marc Lanovaz, Principal investigator, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02153203
- Sponsor's protocol ID
- CERFAS-2014-15-058-P
- Status last verified
- Oct 2016
- First submitted
- 29 May 2014
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using the Prevent-Teach-Reinforce Model to Reduce Problem Behaviors in Children With Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT02153203
- Acronym / sponsor ID
- CERFAS-2014-15-058-P
- Conditions
- Child Development Disorders, Pervasive
- Keywords
- Autism spectrum disorder, Problem behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 2 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral approach | Experimental | Behavioral: Prevent-Teach-Reinforce ModelThe Prevent-Teach-Reinforce Model will be implemented with families in their home settings. |
| Educational approach | Active comparator | Other: Individual Parent Training SessionEach 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. |
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Clinical diagnosis of autism spectrum disorder
- Must exhibit problem behavior
Key exclusion criteria (1 listed)
- Already receiving services to reduce problem behaviors at home
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prevent-Teach-Reinforce ModelImplementation of the model once to twice per week over a period of 8 weeks | Behavioural | Behavioral approach |
| Individual Parent Training SessionOne 2- to 3-hour individual parent training session on the assessment and treatment of problem behavior | Other | Educational approach |
Primary outcome
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
8 secondary outcomes
Change from baseline in quality of life at 8 weeks
Time frame: 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
Change from baseline in parental report of stress at 8 weeks
Time frame: 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
Social validity of the intervention
Time frame: After 8 weeks of intervention
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Lanovaz principal investigator
Université de Montréal
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prevent-Teach-Reinforce Model and Individual Parent Training Session in people with Child Development Disorders, Pervasive, run by Université de Montréal at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2016.