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

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.

Study Overview

• Status: Completed
• Conditions: Autistic Disorder
• Intervention / Treatment: Behavioral: Pivotal Response Training (PRT); Behavioral: Parent Education Group (PEG)

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.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parenting Stress Index Total Score	Higher Scores Mean higher stress level and lower scores mean less stress (Range: Minimum = 36; Maximum=180).	Baseline, 12 weeks
Family Empowerment Scale Total Score	Higher Scores Mean better/more empowered and lower scores mean worse/less empowered (Range: Minimum = 24; Maximum=170).	Baseline, 12 weeks
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).	Baseline, 12 weeks
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).	Baseline, 12 weeks
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).	Baseline, 12 weeks
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).	Baseline, 12 weeks

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Autism Speaks

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: July 20, 2011
• First Submitted That Met QC Criteria: June 17, 2013
• First Posted (Estimate): June 20, 2013

Study Record Updates

• Last Update Posted (Actual): August 16, 2019
• Last Update Submitted That Met QC Criteria: July 10, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Autism PRT
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Autistic Disorder
• Other Study ID Numbers: SU-11022010-7151

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No