Clinical trial NCT01881750: Pivotal Response Group Treatment for Parents of Young Children With Autism
Official title: Pivotal Response Group Treatment for Parents of Young Children With Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autistic Disorder
Keywords: Autism PRT
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Autism Speaks
First posted: 2013-06-20
Enrollment: 53
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change From Baseline in Communication During Structured Lab Observation (SLO) at 12 Weeks
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Parenting Stress Index Total Score
timeFrame: Baseline, 12 weeks
measure: Family Empowerment Scale Total Score
timeFrame: Baseline, 12 weeks
measure: Behavior Rating Inventory of Executive Function- Preschool Global Executive Composite Score
timeFrame: Baseline, 12 weeks
measure: Repetitive Behavior Scale- Revised Total Score
timeFrame: Baseline, 12 weeks
measure: Sensory Profile Questionnaire Sensory Seeking Raw Score
timeFrame: Baseline, 12 weeks
measure: Pediatric Quality of Life Scale Scaled Total Mean Score
timeFrame: Baseline, 12 weeks
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Antonio Hardan, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.