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| Name | Class |
|---|---|
| Autism Speaks | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pivotal Response Training (PRT) | Experimental | 12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions. |
|
| Parent Education Group (PEG) | Placebo Comparator | 12 week program consisting of offering/discussion information for parents. No pivotal response training provided. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pivotal Response Training (PRT) | Behavioral | 12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Parenting Stress Index Total Score | Higher Scores Mean higher stress level and lower scores mean less stress (Range: Minimum = 36; Maximum=180). | Baseline, 12 weeks |
| Family Empowerment Scale Total Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Hardan, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25346345 | Result | 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. | |
| 25911977 | 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. |
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One hundred and thirty-five potential subjects were screened after inquiring about the study; 104 signed a consent form. Forty one did not meet eligibility criteria and 10 decided not to participate before baseline measures.
Recruitment occurred over 2 years (July 2010-June 2012). Participants were recruited through distribution of fliers at clinics and autism awareness events, referral by local professionals, and word of mouth.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pivotal Response Training (PRT) | Pivotal Response Training: 12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions. |
| FG001 | Parent Education Group (PEG) | Parent Education Group: 12 week program consisting of offering/discussion information for parents. No pivotal response training provided. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pivotal Response Training (PRT) | Pivotal Response Training: 12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions. |
| BG001 | Parent Education Group (PEG) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants with available data. | Posted | Mean | Standard Deviation | Utterances | Baseline, 12 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pivotal Response Training (PRT) | Pivotal Response Training: 12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Antonio Hardan, MD | Stanford University School of Medicine | 650-736-1235 | hardanay@stanford.edu |
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| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| Parent Education Group (PEG) | Behavioral | 12 week program consisting of offering/discussion information for parents. No pivotal response training provided. |
|
Higher Scores Mean better/more empowered and lower scores mean worse/less empowered (Range: Minimum = 24; Maximum=170).
| Baseline, 12 weeks |
| Behavior Rating Inventory of Executive Function- Preschool Global Executive Composite Score | Higher scores indicate worse executive functioning and lower scores indicate better executive functioning (Range: Minimum=63; Maximum=189). | Baseline, 12 weeks |
| Repetitive Behavior Scale- Revised Total Score | Higher total scores mean more repetitive behaviors and lower total scores mean fewer repetitive behaviors (Range: Minimum=0; Maximum=129). | Baseline, 12 weeks |
| Sensory Profile Questionnaire Sensory Seeking Raw Score | Higher scores mean more typical sensory seeking behaviors and lower scores mean more abnormal sensory seeking behaviors (Range: Minimum=0; Maximum=85). | Baseline, 12 weeks |
| Pediatric Quality of Life Scale Scaled Total Mean Score | Higher scores mean better quality of life and lower scores mean worse quality of life (Range: Minimum=0; Maximum=100). | Baseline, 12 weeks |
Parent Education Group: 12 week program consisting of offering/discussion information for parents. No pivotal response training provided.
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Secondary | Parenting Stress Index Total Score | Higher Scores Mean higher stress level and lower scores mean less stress (Range: Minimum = 36; Maximum=180). | Participants with available data. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 12 weeks |
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| Secondary | Family Empowerment Scale Total Score | Higher Scores Mean better/more empowered and lower scores mean worse/less empowered (Range: Minimum = 24; Maximum=170). | Participants with available data. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 12 weeks |
|
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| Secondary | Behavior Rating Inventory of Executive Function- Preschool Global Executive Composite Score | Higher scores indicate worse executive functioning and lower scores indicate better executive functioning (Range: Minimum=63; Maximum=189). | Participants with available data. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 12 weeks |
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| Secondary | Repetitive Behavior Scale- Revised Total Score | Higher total scores mean more repetitive behaviors and lower total scores mean fewer repetitive behaviors (Range: Minimum=0; Maximum=129). | Participants with available data. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 12 weeks |
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| Secondary | Sensory Profile Questionnaire Sensory Seeking Raw Score | Higher scores mean more typical sensory seeking behaviors and lower scores mean more abnormal sensory seeking behaviors (Range: Minimum=0; Maximum=85). | Participants with available data. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 12 weeks |
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| Secondary | Pediatric Quality of Life Scale Scaled Total Mean Score | Higher scores mean better quality of life and lower scores mean worse quality of life (Range: Minimum=0; Maximum=100). | Participants with available data. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 12 weeks |
|
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| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | Parent Education Group (PEG) | Parent Education Group: 12 week program consisting of offering/discussion information for parents. No pivotal response training provided. | 0 | 26 | 0 | 26 |
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