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

Primary Purpose

Autistic Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pivotal Response Training (PRT)
Parent Education Group (PEG)
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autistic Disorder focused on measuring Autism PRT

Eligibility Criteria

2 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pivotal Response Training (PRT)

Parent Education Group (PEG)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Parenting Stress Index Total Score
Higher Scores Mean higher stress level and lower scores mean less stress (Range: Minimum = 36; Maximum=180).
Family Empowerment Scale Total Score
Higher Scores Mean better/more empowered and lower scores mean worse/less empowered (Range: Minimum = 24; Maximum=170).
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).
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).
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).
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).

Full Information

First Posted
July 20, 2011
Last Updated
July 10, 2019
Sponsor
Stanford University
Collaborators
Autism Speaks
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1. Study Identification

Unique Protocol Identification Number
NCT01881750
Brief Title
Pivotal Response Group Treatment for Parents of Young Children With Autism
Acronym
PRTG
Official Title
Pivotal Response Group Treatment for Parents of Young Children With Autism
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Autism Speaks

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autistic Disorder
Keywords
Autism PRT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pivotal Response Training (PRT)
Arm Type
Experimental
Arm Description
12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions.
Arm Title
Parent Education Group (PEG)
Arm Type
Placebo Comparator
Arm Description
12 week program consisting of offering/discussion information for parents. No pivotal response training provided.
Intervention Type
Behavioral
Intervention Name(s)
Pivotal Response Training (PRT)
Intervention Description
12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions.
Intervention Type
Behavioral
Intervention Name(s)
Parent Education Group (PEG)
Intervention Description
12 week program consisting of offering/discussion information for parents. No pivotal response training provided.
Primary Outcome Measure Information:
Title
Change From Baseline in Communication During Structured Lab Observation (SLO) at 12 Weeks
Description
Total frequency of child's utterances during 10 minute videotaped SLO assessment.
Time Frame
Baseline, 12 weeks
Secondary Outcome Measure Information:
Title
Parenting Stress Index Total Score
Description
Higher Scores Mean higher stress level and lower scores mean less stress (Range: Minimum = 36; Maximum=180).
Time Frame
Baseline, 12 weeks
Title
Family Empowerment Scale Total Score
Description
Higher Scores Mean better/more empowered and lower scores mean worse/less empowered (Range: Minimum = 24; Maximum=170).
Time Frame
Baseline, 12 weeks
Title
Behavior Rating Inventory of Executive Function- Preschool Global Executive Composite Score
Description
Higher scores indicate worse executive functioning and lower scores indicate better executive functioning (Range: Minimum=63; Maximum=189).
Time Frame
Baseline, 12 weeks
Title
Repetitive Behavior Scale- Revised Total Score
Description
Higher total scores mean more repetitive behaviors and lower total scores mean fewer repetitive behaviors (Range: Minimum=0; Maximum=129).
Time Frame
Baseline, 12 weeks
Title
Sensory Profile Questionnaire Sensory Seeking Raw Score
Description
Higher scores mean more typical sensory seeking behaviors and lower scores mean more abnormal sensory seeking behaviors (Range: Minimum=0; Maximum=85).
Time Frame
Baseline, 12 weeks
Title
Pediatric Quality of Life Scale Scaled Total Mean Score
Description
Higher scores mean better quality of life and lower scores mean worse quality of life (Range: Minimum=0; Maximum=100).
Time Frame
Baseline, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Hardan, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25346345
Citation
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.
Results Reference
result
PubMed Identifier
25911977
Citation
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.
Results Reference
result

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Pivotal Response Group Treatment for Parents of Young Children With Autism

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