Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pivotal Response Group Treatment for Parents of Young Children With Autism (PRTG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01881750
Recruitment Status : Completed
First Posted : June 20, 2013
Results First Posted : August 16, 2019
Last Update Posted : August 16, 2019
Sponsor:
Collaborator:
Autism Speaks
Information provided by (Responsible Party):
Antonio Hardan, Stanford University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Autistic Disorder Behavioral: Pivotal Response Training (PRT) Behavioral: Parent Education Group (PEG) Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pivotal Response Group Treatment for Parents of Young Children With Autism
Study Start Date : July 2010
Actual Primary Completion Date : June 2012
Actual Study Completion Date : July 2012

Arm Intervention/treatment
Experimental: Pivotal Response Training (PRT)
12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions.
Behavioral: Pivotal Response Training (PRT)
12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions.

Placebo Comparator: Parent Education Group (PEG)
12 week program consisting of offering/discussion information for parents. No pivotal response training provided.
Behavioral: Parent Education Group (PEG)
12 week program consisting of offering/discussion information for parents. No pivotal response training provided.




Primary Outcome Measures :
  1. Change From Baseline in Communication During Structured Lab Observation (SLO) at 12 Weeks [ Time Frame: Baseline, 12 weeks ]
    Total frequency of child's utterances during 10 minute videotaped SLO assessment.


Secondary Outcome Measures :
  1. Parenting Stress Index Total Score [ Time Frame: Baseline, 12 weeks ]
    Higher Scores Mean higher stress level and lower scores mean less stress (Range: Minimum = 36; Maximum=180).

  2. Family Empowerment Scale Total Score [ Time Frame: Baseline, 12 weeks ]
    Higher Scores Mean better/more empowered and lower scores mean worse/less empowered (Range: Minimum = 24; Maximum=170).

  3. Behavior Rating Inventory of Executive Function- Preschool Global Executive Composite Score [ Time Frame: Baseline, 12 weeks ]
    Higher scores indicate worse executive functioning and lower scores indicate better executive functioning (Range: Minimum=63; Maximum=189).

  4. Repetitive Behavior Scale- Revised Total Score [ Time Frame: Baseline, 12 weeks ]
    Higher total scores mean more repetitive behaviors and lower total scores mean fewer repetitive behaviors (Range: Minimum=0; Maximum=129).

  5. Sensory Profile Questionnaire Sensory Seeking Raw Score [ Time Frame: Baseline, 12 weeks ]
    Higher scores mean more typical sensory seeking behaviors and lower scores mean more abnormal sensory seeking behaviors (Range: Minimum=0; Maximum=85).

  6. Pediatric Quality of Life Scale Scaled Total Mean Score [ Time Frame: Baseline, 12 weeks ]
    Higher scores mean better quality of life and lower scores mean worse quality of life (Range: Minimum=0; Maximum=100).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01881750


Locations
Layout table for location information
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Autism Speaks
Investigators
Layout table for investigator information
Principal Investigator: Antonio Hardan, MD Stanford University

Publications of Results:
Layout table for additonal information
Responsible Party: Antonio Hardan, Professor, Stanford University
ClinicalTrials.gov Identifier: NCT01881750     History of Changes
Other Study ID Numbers: SU-11022010-7151
First Posted: June 20, 2013    Key Record Dates
Results First Posted: August 16, 2019
Last Update Posted: August 16, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Antonio Hardan, Stanford University:
Autism PRT
Additional relevant MeSH terms:
Layout table for MeSH terms
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders