Pivotal Response Group Treatment for Parents of Young Children With Autism

NCT01881750 | Completed Results

• 1 other identifier: SU-11022010-7151
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Autistic Disorder

Keywords

Autism PRT

Outcome Measures

Primary Outcomes (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.

  Baseline, 12 weeks

Secondary Outcomes (6)

• Parenting Stress Index Total Score

  Baseline, 12 weeks

• Family Empowerment Scale Total Score

  Baseline, 12 weeks

• Behavior Rating Inventory of Executive Function- Preschool Global Executive Composite Score

  Baseline, 12 weeks

• Repetitive Behavior Scale- Revised Total Score

  Baseline, 12 weeks

• Sensory Profile Questionnaire Sensory Seeking Raw Score

  Baseline, 12 weeks

Study Arms (2)

Pivotal Response Training (PRT)

EXPERIMENTAL

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

Behavioral: Pivotal Response Training (PRT)

Parent Education Group (PEG)

PLACEBO COMPARATOR

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

Behavioral: Parent Education Group (PEG)

Interventions

Pivotal Response Training (PRT) BEHAVIORAL

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

Pivotal Response Training (PRT)

Parent Education Group (PEG) BEHAVIORAL

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

Parent Education Group (PEG)

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead
• Autism Speaks: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (2)

• 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.

  PMID: 25346345 RESULT

• 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.

  PMID: 25911977 RESULT

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Limitations and Caveats

The moderate sample size meant that power to detect complex multicomponent patterns was limited. There is also no information available about longer term effects of the treatment.

Results Point of Contact

• Title: Antonio Hardan, MD
• Organization: Stanford University School of Medicine

hardanay@stanford.edu

650-736-1235

Study Officials

• Antonio Hardan, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 20, 2011
• First Posted: June 20, 2013
• Study Start: July 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: July 1, 2012
• Last Updated: August 16, 2019
• Results First Posted: August 16, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)