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Completed

NCT Number: NCT01881750

Pivotal Response Group Treatment for Parents of Young Children With Autism

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.

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Key information

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pivotal Response Training (PRT)

Behavioral

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

Parent Education Group (PEG)

Behavioral

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

Primary outcomes

  1. Change From Baseline in Communication During Structured Lab Observation (SLO) at 12 Weeks

    Time frame: Baseline, 12 weeks

    Total frequency of child's utterances during 10 minute videotaped SLO assessment.

Secondary outcomes

  1. Parenting Stress Index Total Score

    Time frame: Baseline, 12 weeks

    Higher Scores Mean higher stress level and lower scores mean less stress (Range: Minimum = 36; Maximum=180).

  2. Family Empowerment Scale Total Score

    Time frame: Baseline, 12 weeks

    Higher Scores Mean better/more empowered and lower scores mean worse/less empowered (Range: Minimum = 24; Maximum=170).

  3. Behavior Rating Inventory of Executive Function- Preschool Global Executive Composite Score

    Time frame: Baseline, 12 weeks

    Higher scores indicate worse executive functioning and lower scores indicate better executive functioning (Range: Minimum=63; Maximum=189).

  4. Repetitive Behavior Scale- Revised Total Score

    Time frame: Baseline, 12 weeks

    Higher total scores mean more repetitive behaviors and lower total scores mean fewer repetitive behaviors (Range: Minimum=0; Maximum=129).

  5. Sensory Profile Questionnaire Sensory Seeking Raw Score

    Time frame: Baseline, 12 weeks

    Higher scores mean more typical sensory seeking behaviors and lower scores mean more abnormal sensory seeking behaviors (Range: Minimum=0; Maximum=85).

  6. Pediatric Quality of Life Scale Scaled Total Mean Score

    Time frame: Baseline, 12 weeks

    Higher scores mean better quality of life and lower scores mean worse quality of life (Range: Minimum=0; Maximum=100).

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Autism Speaks

Registry information

Acronym: PRTG

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 20, 2013
Registry last updated
Aug 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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