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Autistic DisorderPRTGNCT01881750

Pivotal Response Group Treatment for Parents of Young Children With Autism

A study testing Pivotal Response Training (PRT) and Parent Education Group (PEG) in people with Autistic Disorder, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a research study examining the effectiveness of pivotal response treatment group (PRTG) in targeting language skills in young children with autism. Research has demonstrated that behavioral interventions, such as Pivotal Response Training (PRT), lead to improvements in the core symptoms of autism. Read more about this study

Who is it for?
Ages 2 to 6 years
Conditions the study is for
Autistic Disorder
What is being tested?
Pivotal Response Training (PRT) and Parent Education Group (PEG)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
53 participants
Where
1 siteUnited States
Study dates
Jul 2010to Jul 2012
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 2 to 6 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Diagnosis of Autism Spectrum Disorder (ASD) based on Autism Diagnostic Interview - Revised (ADI-R), Autism Diagnostic Observation Schedule (ADOS), Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), and expert clinical opinion
  • Outpatients between 2.0 and 6 years of age of either gender
  • Children of all cognitive levels will be included as long as they are able to participate in the testing procedures to the extent that valid standard scores can be obtained
  • Language delay as measured by the Preschool Language Scale 4th ed. (PLS-4)
  • Participants must have the ability to make meaningful vocalizations, defined as the ability to make contingent vocalizations when prompted (i.e., vocal sound showing intent to communicate, but not necessarily clear words)
  • Stable psychotropic medication(s) or biomedical interventions for at least one month prior to baseline measurements with no anticipated changes during study participation
Show all 13Show fewer
  • Stable behavioral treatment (Applied Behavioral Analysis, Floortime, or other interventions), speech therapy, and school placement for at least 2 months prior to baseline measurements with no expected changes during study participation
  • No more than 60 minutes of 1:1 speech therapy per week
  • The availability of at least one parent who can consistently participate in the group treatment and related activities of the research study
  • Be male or female in good medical health
  • Will be starting PRTG after the first magnetic resonance image (MRI) scan has occured and, if agreeable, blood draw or saliva sample
  • Parents intend on continuing PRTG for a minimum of 12 weeks
  • Parents must be 18 years of age or older.

Who cannot join

  • A current or life-time diagnosis of severe psychiatric disorder (e.g., bipolar disorder…)
  • A genetic abnormality, such as Fragile X, based on genetic testing, done as indicated
  • Presence of active medical problem (e.g., unstable seizure disorder or heart disease)
  • Participants taking psychotropic medications will not be included if their medications have not been stable for over a week
  • Parents who do not have the ability to videotape parent and child interactions on a weekly basis
  • Parents who are not willing to implement intervention strategies for at least one hour a day
  • Parents who plan to alternate which parent attends the group sessions.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford University School of Medicine

    Stanford, California, 94305

Other trials in United States

About this study

This is a research study examining the effectiveness of pivotal response treatment group (PRTG) in targeting language skills in young children with autism. Research has demonstrated that behavioral interventions, such as Pivotal Response Training (PRT), lead to improvements in the core symptoms of autism. The purpose of this study is to further examine the effectiveness of teaching pivotal response treatment to parents of children with autism in a group format. To determine the effectiveness of pivotal response training group (PRTG) it will be compared to another parent education group by conducting a randomized controlled 12-week trial.

Read the detailed description

This is a research study examining the effectiveness of pivotal response treatment group (PRTG) in targeting language skills in young children with autism. Research has demonstrated that behavioral interventions, such as Pivotal Response Training (PRT), lead to improvements in the core symptoms of autism. Researchers have begun to develop strategies to investigate the effectiveness of teaching parents how to implement PRT in a group format, as opposed to an individual format. Preliminary data has demonstrated that teaching PRT in a group format has shown to be effective in teaching parents and increasing children's communication skills. The purpose of this study is to further examine the effectiveness of teaching pivotal response treatment to parents of children with autism in a group format. To determine the effectiveness of pivotal response training group (PRTG) it will be compared to another parent education group by conducting a randomized controlled 12-week trial. PRTG will aim to teach parents pivotal response training strategies, whereas the parent psychoeducational group (PEG) will aim to teach parents information with regards to assessment and treatment for children with autism. By conducting this research it will improve researchers understanding of group treatment options for individuals with autism and allow us to help in the development of therapeutic approaches that can meet the increasing service demands for families.

Being tested
Pivotal Response Training (PRT), Parent Education Group (PEG)
Keywords
Autism PRT
Medical subject headings
Autistic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pivotal Response Training (PRT)Behavioural

    12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions.

  • Parent Education Group (PEG)Behavioural

    12 week program consisting of offering/discussion information for parents. No pivotal response training provided.

Study groups in NCT01881750
Study groupRoleWhat they receive
Pivotal Response Training (PRT)Experimental12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions.
Receives: Behavioral: Pivotal Response Training (PRT)
Parent Education Group (PEG)Placebo comparator12 week program consisting of offering/discussion information for parents. No pivotal response training provided.
Receives: Behavioral: Parent Education Group (PEG)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Communication During Structured Lab Observation (SLO) at 12 Weeks

    Total frequency of child's utterances during 10 minute videotaped SLO assessment.

    Measured: Baseline, 12 weeks

Secondary outcomes (6)

  1. Parenting Stress Index Total Score

    Higher Scores Mean higher stress level and lower scores mean less stress (Range: Minimum = 36; Maximum=180).

    Measured: Baseline, 12 weeks

  2. Family Empowerment Scale Total Score

    Higher Scores Mean better/more empowered and lower scores mean worse/less empowered (Range: Minimum = 24; Maximum=170).

    Measured: Baseline, 12 weeks

  3. Behavior Rating Inventory of Executive Function- Preschool Global Executive Composite Score

    Higher scores indicate worse executive functioning and lower scores indicate better executive functioning (Range: Minimum=63; Maximum=189).

    Measured: Baseline, 12 weeks

  4. Repetitive Behavior Scale- Revised Total Score

    Higher total scores mean more repetitive behaviors and lower total scores mean fewer repetitive behaviors (Range: Minimum=0; Maximum=129).

    Measured: Baseline, 12 weeks

  5. Sensory Profile Questionnaire Sensory Seeking Raw Score

    Higher scores mean more typical sensory seeking behaviors and lower scores mean more abnormal sensory seeking behaviors (Range: Minimum=0; Maximum=85).

    Measured: Baseline, 12 weeks

  6. Pediatric Quality of Life Scale Scaled Total Mean Score

    Higher scores mean better quality of life and lower scores mean worse quality of life (Range: Minimum=0; Maximum=100).

    Measured: Baseline, 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2013 (estimated)
  2. Study startJul 2010
  3. Primary completionJun 2012
  4. Study completionJul 2012

Resources

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
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01881750
Sponsor's protocol ID
SU-11022010-7151
Acronym
PRTG
Status last verified
Jul 2019
First submitted
20 Jul 2011
Last updated
16 Aug 2019
Data monitoring committee
No
Individual data sharing
No

Publications

  • Hardan AY, Gengoux GW, Berquist KL, Libove RA, Ardel CM, Phillips J, Frazier TW, Minjarez MB. A randomized controlled trial of Pivotal Response Treatment Group for parents of children with autism. J Child Psychol Psychiatry. 2015 Aug;56(8):884-92. doi: 10.1111/jcpp.12354. Epub 2014 Oct 27.

    PubMed 25346345

  • Gengoux GW, Berquist KL, Salzman E, Schapp S, Phillips JM, Frazier TW, Minjarez MB, Hardan AY. Pivotal Response Treatment Parent Training for Autism: Findings from a 3-Month Follow-Up Evaluation. J Autism Dev Disord. 2015 Sep;45(9):2889-98. doi: 10.1007/s10803-015-2452-3.

    PubMed 25911977

Questions about this trial

What is this clinical trial studying?

A study testing Pivotal Response Training (PRT) and Parent Education Group (PEG) in people with Autistic Disorder, run by Stanford University at 1 site in United States.

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 13 inclusion and 7 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 16 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 16 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Communication During Structured Lab Observation (SLO) at 12 Weeks (time frame: Baseline, 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01881750, which also lists 2 linked publications.

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 16 Aug 2019.

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