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

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Stanford University

Status

Completed

Conditions

Autistic Disorder

Treatments

Behavioral: Pivotal Response Training (PRT)
Behavioral: Parent Education Group (PEG)

Study type

Interventional

Funder types

Other

Identifiers

NCT01881750
SU-11022010-7151

Details and patient eligibility

About

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.

Full 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.

Enrollment

53 patients

Sex

All

Ages

2 to 6 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

53 participants in 2 patient groups, including a placebo group

Pivotal Response Training (PRT)
Experimental group
Description:
12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions.
Treatment:
Behavioral: Pivotal Response Training (PRT)
Parent Education Group (PEG)
Placebo Comparator group
Description:
12 week program consisting of offering/discussion information for parents. No pivotal response training provided.
Treatment:
Behavioral: Parent Education Group (PEG)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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