N/A
N=53
Pivotal Response Group Treatment for Parents of Young Children With Autism
Autistic Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01881750 ↗Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Change From Baseline in Communication During Structured Lab Observation (SLO) at 12 Weeks — 45.7; 40.8; 64.5; 51.4 Utterances — p=0.42
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pivotal Response Training (PRT) (Behavioral); Parent Education Group (PEG) (Behavioral)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Communication During Structured Lab Observation (SLO) at 12 Weeks |
45.7; 40.8; 64.5; 51.4 | 0.42 |
| SECONDARY Parenting Stress Index Total Score |
92.04; 98.38; 90.91; 95.95 | — |
| SECONDARY Family Empowerment Scale Total Score |
127.78; 121.73; 130.14; 121.68 | — |
| SECONDARY Behavior Rating Inventory of Executive Function- Preschool Global Executive Composite Score |
124.19; 124.19; 113.28; 119.91 | — |
| SECONDARY Repetitive Behavior Scale- Revised Total Score |
21.70; 26.23; 20.04; 30.05 | — |
| SECONDARY Sensory Profile Questionnaire Sensory Seeking Raw Score |
60.81; 60.92; 61.52; 65.52 | — |
| SECONDARY Pediatric Quality of Life Scale Scaled Total Mean Score |
64.86; 67.18; 67.38; 67.45 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01881750). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.