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Pivotal Response Group Treatment for Parents of Young Children With Autism

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ClinicalTrials.gov Identifier: NCT01881750
Recruitment Status : Unknown
Verified June 2013 by Antonio Hardan, Stanford University.
Recruitment status was:  Active, not recruiting
First Posted : June 20, 2013
Last Update Posted : June 20, 2013
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 Behavioral: Parent Education Group 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 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 : September 2010
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : September 2013

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

Placebo Comparator: PEG Behavioral: Parent Education Group
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 parent-child and clinician-child interactions at 6, 12, and 24 weeks [ Time Frame: 6, 12 and 24 weeks ]

Secondary Outcome Measures :
  1. Parenting Stress Index [ Time Frame: 6, 12 and 24 weeks ]
  2. Family Empowerment Scale [ Time Frame: 6, 12 and 24 weeks ]
  3. Behavior Rating Inventory of Executive Function [ Time Frame: 6, 12 and 24 weeks ]
  4. Repetitive Behavior Scale [ Time Frame: 6, 12 and 24 weeks ]
  5. Sensory Profile Questionnaire [ Time Frame: 6, 12 and 24 weeks ]
  6. Pediatric Quality of Life Scale [ Time Frame: 6, 12 and 24 weeks ]


Information from the National Library of Medicine

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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
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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Autism Speaks
Investigators
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Principal Investigator: Antonio Hardan, MD Stanford University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Antonio Hardan, Associate 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
Last Update Posted: June 20, 2013
Last Verified: June 2013

Keywords provided by Antonio Hardan, Stanford University:
Autism PRT

Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders